Assessment and effects of Therapeutic Patient Education for patients in hemodialysis: A systematic review

International Journal of Nursing Studies 48 (2011) 1570–1586

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Review

Assessment and effects of Therapeutic Patient Education for patients in hemodialysis: A systematic review Lae¨titia Idier a,*, Aure´lie Untas b, Miche`le Koleck a, Philippe Chauveau c, Nicole Rascle a a

Laboratory of Health Psychology and Quality of Life EA4139, University Bordeaux Segalen, 3 ter Place de la Victoire, 33076 Bordeaux cedex, France Laboratory of Psychopathology and Health Processus EA 4057, University Paris Descartes, Sorbonnes Paris Cite´, France c AURAD Aquitaine (Association for the use of artificial kidney at home and out-center), Gradignan, France b

A R T I C L E I N F O

A B S T R A C T

Article history: Received 6 May 2011 Received in revised form 17 August 2011 Accepted 22 August 2011

Objective: This review examined the impact of Therapeutic Patient Education (TPE) programs in hemodialysis and the assessment of these programs. Review methods and data sources: A systematic review was performed. Bibliographical research was done with a database in the social and human sciences (PsychINFO, PsycARTICLES, SocINDEX with Full Text and the Psychology and Behavioural Sciences Collection). References were also searched in several reviews specialized in nephrologydialysis and in patient education. Articles were classified according three different outcomes: (1) physiological outcomes, (2) psychosocial outcomes, (3) or combined criteria. Results: 35 articles were selected. The majority dealt with purely physiological outcomes (18) and the minority concerned only psychosocial outcomes (4). Fifteen articles discussed both physiological and psychosocial outcomes, i.e. combined criteria. Beneficial effects were shown such as improvements in knowledge, adherence and quality of life. Most educational interventions were performed by nurses. Conclusion: This systematic review found that educational programs in dialysis have become more numerous and efficient, with a prevalence of assessment based on physiological outcomes. TPE is a global management method based on both the physiological and the psychological well-being of the patient. Studies that take into account both physiological and psychosocial variables are very useful for understanding the effects of TPE programs on dialysis patients. The review shows that nurses play an important role in TPE and that they require varied communicational, educational, animation and assessment skills. These positive effects are encouraging for nurses to stimulate the development of TPE programs for dialysis patients in their multidisciplinary teams. The nurse’s role is important for the commitment of each health caregiver (nurse, physician, dietician, pharmacist, psychologist, etc.) for the global management of patients in the TPE process. ß 2011 Elsevier Ltd. All rights reserved.

Keywords: Dialysis patients Therapeutic Patient Education Effects of Therapeutic Patient Education Physiological outcomes Psychosocial outcomes Systematic review

What is already known about the topic?  Patients with End-Stage Renal Disease who are treated by hemodialysis need to acquire specific skills to manage their chronic disease.

* Corresponding author. Tel.: +33 05 57 57 18 11; fax: +33 05 56 31 42 11. E-mail address: [email protected] (L. Idier). 0020-7489/$ – see front matter ß 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.ijnurstu.2011.08.006

 Therapeutic Patient Education (TPE) has been developed to help patients and their families. A TPE program with dialysis patients may be beneficial for them to manage their lives in the best possible way. What this paper adds  The review shows that a range of interventions has demonstrated several positive effects on adherence, knowledge, quality of life, and so on.

L. Idier et al. / International Journal of Nursing Studies 48 (2011) 1570–1586

 While the assessment of psychosocial outcomes in TPE programs is necessary to improve understanding of the educational effects of TPE, the assessment of physiological outcomes is predominant. The combination of these psychosocial and physiological criteria could help to evaluate impact and long-term effects.  The nurse’s role is very important to conduct TPE interventions and initiate multidisciplinary programs and assessment to obtain an overall understanding of the patient. 1. Introduction 1.1. Definition of Therapeutic Patient Education Therapeutic Patient Education (TPE) is important for nursing practice and other professionals who work with chronic disease patients. According to the consensual definition of the World Health Organization (WHO) (1996), ‘‘TPE helps patients acquire or maintain the skills they need to manage their life with a chronic disease in the best possible way. It covers organized activities, including psychosocial support, designed to make patients fully aware about their disease and to inform them about care, hospital organization and procedures, and health- and disease-related behaviors. It helps patients and their families understand and deal with the disease and its treatment together, in order to maintain or even improve quality of life’’. Two main goals can summarize TPE interventions: improve adherence and quality of life in order to better manage life with disease. Another goal is to better collaborate with caregivers. 1.2. Organization of Therapeutic Patient Education Under the heading of ‘‘TPE’’, a wide range of organized, structured and diverse activities can be observed. TPE can consist in a single intervention as a ‘‘TPE intervention’’ or in several interventions as ‘‘TPE programs’’. It can be composed of various individual or collective activities: creating awareness, advising, learning, training, sharing experiences and knowledge between patients, providing psychosocial support, etc. TPE interventions can be done by a single health professional but should be performed by a multidisciplinary team (nurses, physician, dietician, pharmacist, psychologist, etc.). 1.3. Therapeutic Patient Education in hemodialysis: rationale TPE programs and publications are the most highly developed in endocrinology as the first patient education activities were undertaken in diabetology after the discovery of insulin (Albano et al., 2008). TPE is more recent in hemodialysis patients. Hemodialysis is the most frequent technique of renal replacement therapy for patients with end stage renal disease. The patients need to be treated for 4 h, three times a week as a standard protocol. This entails numerous alterations and adjustments in the life of the patient and his family. Individuals must reorganize their lives to fit in with the rhythm of the dialysis sessions. The dietetic regime is restrictive (low in salt, phosphorus, potassium

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and fluid). The mean medication count is higher than 10 pills or capsules a day. In this perspective, non-adherence is commonly observed in dialysis patients (Bleyer et al., 1999; Hecking et al., 2004; Saran et al., 2003). In Europe, about 20% of the patients are considered non-compliant to potassium and 12% non-compliant to phosphorus (Hecking et al., 2004; Saran et al., 2003). Dialysis and the numerous restrictions it entails can provoke stress that patients must cope with. Indeed, many studies show that dialysis patients are more depressed, more anxious and have a lower quality of life than the general population (Cukor et al., 2008; Fukuhara et al., 2003; Kimmel and Peterson, 2005). A TPE program with hemodialysis patients would likely help patients to better understand their renal disease, to acquire self-care skills and life skills, and to play an active part in their dialysis treatment in order to improve adherence and quality of life. 1.4. Therapeutic Patient Education in hemodialysis: what has been done? In dialysis, TPE references have become more and more numerous. Different reviews show the evolution of TPE in dialysis and the appearance of this recent concept. Kaptein et al. (2010) recently studied the historical evolution of research conducted in the field of psycho-nephrology. They noted that research in education mainly dates back to the 90 s in dialysis. Recently, articles have included the concept of self-management, in which patients play an active part in their disease. The first literature review was published by Morgan (2000). It focused on the different approaches used to improve diet adherence in dialysis patients. Three main approaches were discussed: behavioral, educational and nurse-oriented (education carried out by nurses). The number of studies cited was quite small and the focus was on compliance. In 2005, two literature reviews dealt with fluid compliance: the first one investigated the impact of psycho-educational interventions (Welch and Thomas-Hawkins, 2005) and the second one looked at psychosocial interventions (Sharp et al., 2005a). Psycho-education and TPE share common aims. They include psychological causes, the effects of disease and the quality of the relationship between the physician, the patient and his family (Gay and Cuche, 2006). This approach was first developed in psychiatry. Interventions promoted by these two reviews were mainly based on the Transtheoretical Model (Prochaska and Di Clemente, 1992), the Health Belief Model (Rosenstock, 1974) or the Behavioral Cognitive Therapy. The Transtheoretical Model helps to better understand the different stages that people go through to acquire a new behavior (precontemplation, contemplation, preparation, action, maintenance). The Health Belief Model suggests that adopting protective health behaviors is determined by four beliefs (perceived susceptibility, perceived severity, perceived benefits, and perceived barriers). Most studies of these two literature reviews show a decrease in Interdialytic Weight Gain (IDWG) after interventions, which means a higher adherence to fluid recommendations. Interdialytic Weight Gain is an indicator of fluid compliance that is representative of the weight gain between two dialysis sessions.

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The main limitation of these two reviews is that they focused on fluid compliance and that the studies cited did not assess psychosocial variables. The aim of TPE is not restricted to the improving adherence or medical and biological criteria but should involve improvement of Quality of Life. Indeed, patient education programs should combine adaptation skills and the adjustment of the patient to his disease, beliefs and representations, and subjective and objective needs. Nurses and other TPE health professionals should evaluate psychosocial outcomes. Finally and more recently, Mason et al. (2008) published a systematic review of educational randomized interventions on patients with kidney disease. They included studies that assess medical, dietary and psychosocial outcomes. The work was mainly descriptive and concerned different stages of kidney disease (predialysis care and dialysis care). Moreover, they did not propose any practical advice that might be useful for TPE health professionals. With the increasing number of TPE programs developed in the field of end-stage renal disease, the principal aim of this literature review was to better understand the impact of TPE with dialysis patients. There were three specific aims: (1) to investigate the type and the format of TPE developed in hemodialysis, which is the real point of entry into the disease with the beginning of treatment; (2) to obtain a state-of-the-art view of the effects of TPE in hemodialysis and the types of outcomes assessed; (3) to define the best type of TPE program and how to evaluate them. 2. Methods 2.1. Criteria for considering studies for this review 2.1.1. Type of intervention We included studies reporting educational interventions for hemodialysis patients. We used the WHO definition of TPE (1996): i.e. a set of structured and diversified activities (one intervention or a program with several interventions) organized by one or several health professionals (nurse, dietician, physician, etc.). The aims of TPE interventions are to improve knowledge, self-care skills, adherence, medical and biological state, psychosocial and life skills, quality of life, well-being, etc. 2.1.2. Inclusion criteria Studies were included if they met the following criteria: - studies about educational programs or interventions for patients treated by hemodialysis in hospitals, clinics or dialysis units, - educational programs or interventions for adult hemodialysis patients (participants 18 years old or over), - results focused on patient outcomes, - fully available article, - articles written in English, - studies including a before/after TPE intervention assessment. We included randomized controlled trials (RCTs), nonrandomized controlled trials (NRC-Ts), controlled before

and after studies (CBAs) and before-after studies without a control group (Bowling, 2002). 2.1.3. Exclusion criteria Studies were excluded if they met the following criteria: - studies with patients treated by peritoneal dialysis and home hemodialysis, - case studies or very small samples (<10) and studies using descriptive methods (and non-statistic methods), - studies about intervention without educational content or components (for example: psychosocial intervention or Behavioral Cognitive Therapy without educational content). 2.2. Search methods for identification of studies 2.2.1. Database search First, a bibliographical search was done using a database with simultaneous access to several reviews in the social and human sciences including PsychINFO, PsycARTICLES, SocINDEX with Full Text and the Psychology and Behavioural Sciences Collection. We also did a search in the medical database ‘‘MEDLINE’’. Many articles appeared when all the key words were included. However, most articles were not within the field of hemodialysis (they were included in the field of peritoneal dialysis or kidney transplant or other pathologies) or did not concern TPE. They had already been listed with the social and human sciences database or in specialized reviews. For this reason, the present review includes only the articles from the social and human sciences. The key words used were ‘‘hemodialysis’’ or ‘‘dialysis’’ and ‘‘education’’, or ‘‘patient education’’, or ‘‘health education’’, or ‘‘self-care’’, or ‘‘self-efficacy’’, or ‘‘self-management’’, or ‘‘teaching’’, or ‘‘empowerment’’, or ‘‘behavior therapy’’. When using all the key words, the bibliographical search produced too many hits to be able to select relevant articles (N = 562 228), so we used the key words separately so as to target articles more specifically. In order to obtain as many articles as possible on our topic, no time restriction was taken into account. The databases consulted began in 1972. Our latest bibliographical search dates back to March 2011. 2.2.2. Screening of related literature Next, we did a bibliographical search in several reviews specialized in nephrology-dialysis (American Journal of Kidney Diseases, Journal of Renal Nutrition, International Journal of Nursing Studies, and so on) and in those specialized in patient education (Patient Education and Counseling). The same key words were used in the browsers of the different reviews. Finally, the bibliographical references of the articles were studied so as to select other articles on our topic. 2.3. Data extraction and analysis 2.3.1. Study selection The abstracts of all studies identified by the search strategies were examined by the principal investigator (LI).

L. Idier et al. / International Journal of Nursing Studies 48 (2011) 1570–1586

Those that were considered to evaluate an educational intervention for hemodialysis patients and to follow the inclusion/exclusion criteria were identified for more detailed examination by the first investigator (LI). The full text version of these studies was then obtained and studied with great attention. Undecided cases were verified and studied by a second (AU) and third (MK) reviewer. 2.3.2. Data extraction Data extracted included study design (type of education, type of intervention, format individual or collective) and participant type (control group or not, randomization or not). We also extracted the type of evaluation (time and variables) and the main results and effects of education programs. According to the time of assessments after TPE intervention, we determined three time points: short-term (less than two months after intervention); medium-term (from two to eleven months); and long-term (more than twelve months). These data are mentioned in the different tables. 2.3.3. Data analysis To better understand the impact of the different TPE programs, we classified the articles according to the type of outcomes evaluated in selected studies: - Physiological outcomes of TPE programs to assess adherence to dietary and fluid recommendations and medical knowledge, such as biological criteria (like phosphorus, calcium, potassium) and clinical criteria (such as interdialytic weight gain, physical activity); - Psychosocial outcomes of TPE programs (psychological well-being, quality of life, anxiety, depression); - Combined criteria (studies evaluating a combination of physiological and psychosocial outcomes). 3. Results 3.1. Search results 3.1.1. Database search The initial search in the databases in social and human sciences highlighted 725 articles, that is: - 338 articles with the key word ‘‘hemodialysis’’ and successively the key words ‘‘education’’, then ‘‘patient education’’, and so on. - 387 articles with the key word ‘‘dialysis’’ and successively the other key words. We did not retain the following: references with summaries only; doublet articles; articles which took into account other pathologies despite the key words ‘‘hemodialysis’’ and ‘‘dialysis’’; studies regarding home hemodialysis or peritoneal dialysis; articles with unassessed therapeutic education programs or those which did not really correspond to TPE (for instance, the impact of voluntary work, leisure activities, and so on). Hence, 12 articles were finally selected. 3.1.2. Screening of related literature From the bibliographical references of some articles or reviews of the literature and research on various

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nephrology-dialysis and education reviews, we identified 23 more studies. Therefore, a total of 35 papers were selected for this literature review. The articles were classified and analyzed according to the three types of outcomes mentioned above. A flow diagram of studies from search to inclusion is shown in Fig. 1. 3.2. Evaluation of TPE programs based on physiological outcomes Eighteen studies only assessed physiological outcomes of TPE programs (18/35) (Table 1). Fifteen articles were published between 1993 and 2009, but most in the 2000s. Seven articles were published in the United States, five in Asia, five in Europe and one in Iran. The aim of 16 studies was to assess the improvement in dietary or fluid adherence with several biological outcomes (phosphorus and calcium levels, potassium levels, creatinine level, albumin level, etc) or clinical criteria (interdialytic weight gain). The other studies concerned compliance and knowledge on hygiene of vascular access (Brantley et al., 1990) and physical activity with exercise time, cardiorespiratory capacity data (Konstantinidou et al., 2002). Medical knowledge was also evaluated by six studies. Ten studies proposed an educational program to non-adhering subjects. Twelve programs were composed of individual activities. Four used an intervention group design (Christensen et al., 2002; Nozaki et al., 2005; Reddy et al., 2009; Shaw-Stuart and Stuart, 2000) or combined individual and collective activities (Baraz et al., 2010; Konstantinidou et al., 2002). Most educational interventions were performed by a nurse (n = 8) and a dietician (n = 6). One intervention was made by a psychologist (Christensen et al., 2002) and two by a multidisciplinary team (Barnett et al., 2007; Casey et al., 2002). The methodology and theoretical content of interventions were strictly educational in most studies (n = 12). On the contrary, the other studies (n = 6) associated educational content with psychosocial techniques such as behavioral and cognitive therapies, and self-efficacy1 (Casey et al., 2002; Christensen et al., 2002; Nozaki et al., 2005; Sagawa et al., 2001; Tsay, 2003). Half of the studies compared an experimental group to a control group. The other works were composed of a unique ‘‘intervention’’ group (n = 6) or compared two different intervention groups (n = 2). Only eight studies were randomized. The impact of educational programs was assessed in the medium-term except in the study by Brantley et al. (1990), which assessed the impact of intervention in the long run. All studies reported at least one positive effect in addition to the educational program (Table 1). The main changes were improved knowledge, blood tests and interdialytic weight gain. Some results

1 The notion of self-efficacy relative to a disease (or health) was developed by Bandura (1997). It deals with the individual’s belief in their capacity to muster the necessary resources to control some situations (linked with the disease) and to be successful in doing so.

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« HEMODIALYSIS » and - “education” = 82 - “patient education” =81 - “health education” =58 - “self-care” =22 - “self-management” =7 - “self-efficacy” =26 - “teaching” =9 - “behaviour therapy” =49 - “empowerment” =4

« DIALYSIS » and - “education” =108 - “patient education” =89 - “health education” =72 - “self-care”=26 - “self-management” =6 - “self-efficacy” =20 - “teaching” =18 - “behaviour therapy” =44 - “empowerment” =4

Total= 338 articles

Total= 387 articles

725 articles identified in database in social and human sciences.

713 articles excluded due to not fulfilling eligibility criteria

12 studies considered for inclusion. Also 23 studied retrieved by handsearching in reviews specialized in nephrology-dialysis and in patient education.

35 articles fulfilling eligibility criteria

Physiological outcomes of TPE programs (n=18)

Psychosocial outcomes of TPE programs (n=4)

Physiological and psychosocial outcomes of TPE programs (n=13)

Fig. 1. The flow diagram illustrating the selection of publications.

were immediate but not all of them lasted in the long term. Seven studies (7/9) demonstrated a decrease in phosphorus level; two showed a decrease in calcium (2/ 6) and three showed an improvement in calcium/ phosphorus product levels (3/3). Results were sometimes significant for experimental groups but not always if experimental groups were compared with a control group. Only one study evaluated the effect of nutritional education on potassium adherence (Baraz et al., 2010) and showed no significant effect. TPE programs about fluid recommendations were effective because 6 studies (out of six) demonstrated a decrease in interdialytic weight gain. Knowledge was improved in each study (5/ 5) but the post-test time was not the same in all studies. The other results (albumin level, sodium level, physical

activity criteria, compliance on hygiene of vascular access) are presented in Table 1. 3.3. Evaluation of TPE programs based on psychosocial outcomes Only four articles made an assessment based of strictly psychosocial outcomes (4/35) (Table 2). Only the articles with educational content or concerning self-care skills were included (to identify and relieve the symptoms; to perform technical gestures and some care; to adapt one’s food to one’s disease, and so on). Three out of the four selected papers were written by the same author and concerned Taiwanese patients. The fourth article concerned American patients (Mathers, 1999). The studies

Table 1 Characteristics of quantitative studies reviewed with medical assessment of TPE programs (ranked in alphabetical order). Reference and country

Intervention description

Sample

Evaluations

Variables

Results

Ashurst and Dobbie (2003) England

Type: Educational intervention to improve phosphate and calcium Intervention: One educational session and one-to-one teaching session Format: single Educator: renal dietician Type: Educational intervention on fluid and dietary compliance Intervention: 2 different educational sessions: G1: Oral education G2: Video education Format: single and group Educator: renal nurse

N = 58 with elevate phosphate CG: yes Randomization: yes

T1: pretest T2: posttest at 3 months

Phosphate, Calcium

EG: # (15%) phosphate For EG compared to CG: lower phosphate (p < 0.01)

Baraz et al. (2010) Iran

Brantley et al. (1990) USA

Casey et al. (2002) England

Type: Educational intervention on fluid compliance Intervention: Education on fluid control, drinks, salt, complications One intervention each week during 2 month Format: single Educators: Dietician and other healthcare professionals Type: Education and behavioral management on cleansing compliance Intervention: 4 conditions: G1: Education: 20 min of video 3 times a week G2: Behavioral Management with monetary incentive G3: Education and behavioral management CG: Control group Format: single Educators: nurses Type: Stepped verbal and written reinforcement of fluid compliance Intervention: Program during 18 weeks over 3 periods: (1) existing compliance advice (2) reinforcement of fluid concordance during dialysis therapy (3) leaflet to improve practical information on fluid balance, measuring fluid allowance and hints for controlling fluid intake Format: single Educators: dietician, nurses and medical staff

Group of oral education: # *creatinine (p < 0.001) # *phosphate (p < 0.01) # *uric acid (p < 0.01) # *IWG (p < 0.001) No effect on potassium, calcium, sodium and albumin Group of video education: # *phosphate (p < 0.01) # *calcium (p < 0.001) # *uric acid (p < 0.05) # *IDWG (p < 0.001) No effect on potassium, sodium and albumin # *IDWG (p < 0.01) Predialysis systolic pressure: no effect

N = 63 2 educational groups CG: no Randomization: yes

T1: pretest T2: posttest at 2 months

Potassium, Sodium, Albumin, Phosphate, Creatinine, Uric acid, IDWG

N = 26 patients identified as noncompliant CG: no Randomization: no

T1: pretest at 2 months before education intervention T2: posttest at 2 months

IDWG, Predialysis systolic pressure

N = 56 G=4 CG: yes Randomization: not reported

T1: pretest T2: after intervention T3: posttest at 1 month T4: posttest at 1 year

Knowledge, Compliance (vascular access cleansing)

T2: better knowledge for G1, G2 and G3 than for CG (p < 0.001) T2 and T3: G3 and G2 with better compliance that G1 and CG (p < 0.001) T4: no effect

N = 21 CG: no Randomization: no

T1: at 6 weeks (after session 1) T2: at 12 weeks (after session 2) T3: at 18 weeks (after session 3)

IDWG

Between T1 & T2: 62% of patients improve IDWG Between T1 & T3: 48% of patients improve IDWG but these results are non significant

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Barnett et al. (2007) Malaysia

Calcium: no effect

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Intervention description

Sample

Evaluations

Variables

Results

Christensen et al. (2002) USA

Type: Behavioral self-regulation with intervention on fluid compliance Intervention: several sessions during 7 weeks based on behavior therapy and self-regulation protocol Format: group Educators: psychotherapists

N = 40 patients identified as non-compliant CG: yes Randomization: no

IDWG

At T3: # of IDWG for EG (p < 0.001)

Deimling et al. (1984) USA

Type: Education on phosphorus Intervention: 3 conditions according to the group: G1: Routine care with routine phosphorus counseling G2: Phosphorus Education with slide/tape program while on dialysis and routine care G3: Contingency Contracting with slide/tape program while on dialysis, contract with a nurse for mutually agreed goals with an algorithm on phosphate control and management Format: single Educators: nurses, research nurse, physician Type: Diet Education on phosphorus Intervention: 20 to 30 minutes per month of additional diet education on monthly laboratory values and knowledge of dietary phosphorus management, period: 6 months Format: single Educator: dietician

N = 37 G=3 CG: yes Randomization: yes

T1: pretest at 2 weeks before intervention T2: posttest at 2 weeks T3: posttest at 7 and 8 weeks T1: pretest T2: posttest (G2 & G3) T3: posttest at 10 weeks

Knowledge, Phosphorus

T2: G2 and G3 increased their phosphorus knowledge (p is not reported) T3: only G3 sustained and surpassed their original increase in knowledge Phosphorus: no effect

At T2: EG: " *of knowledge of 9% (p < 0.01), # *of serum phosphorus (p < 0.001) and # *calcium/phosphorus product (p < 0.001), no effect on calcium For EG compared to CG: At 6 months, gains in knowledge were higher; and calcium/phosphorus product were lower for EG (p < 0.01), no effect on phosphorus and calcium At T2: - " *of exercise time for G1, G2 and G3 (p < 0.05) - G1: higher exercise time than G2, G3, G4 and G5 (p < 0.05) - Improvement of cardiorespiratory capacity for G1 (5 indicators out of 7), G2 (4/7) and G3 (3/7) - Better improvement for G1 compared to G2, G3, G4 and G5 (p < 0.05) - G1: highest dropout rate (24%) than for G2 and G3 (17%) (p < 0.05) - Exercises during HD treatment under the supervision are preferred and more effective At T2: Higher improvement of albumin for EG compared to CG (p < .001)

Ford et al. (2004) USA

N = 63 with hyperphosphatemia CG: yes Quasi-experimental design

T1: pretest T2: after program at 6 months

Phosphorus, Calcium, PTH (parathyroid hormone), Calcium/ phosphorus product levels, Knowledge

Konstantinidou et al. (2002) Greece

Type: Exercise training with rehabilitation programs Intervention: 5 conditions according to the group (during 6 months): G1: Training sessions 3 times a week during 60 min on non dialysis days in center of rehabilitation G2: Exercise during HD treatment under supervision 3 times a week during 60 min (bicycle ergometer) G3: Unsupervised moderate exercise training program at home (cycle ergometer and simple exercises at least 5 times a week) G4: HD patients without intervention G5: Volunteer healthy controls with sedentary lifestyle Format: single or group Educators: physical education teachers

N = 63 CG: yes Randomization: yes

T1: pretest T2: post-test at 6 months (end of rehabilitation programs)

Exercise time, Cardiorespiratory Capacity data (heart rate, ventilation, peal oxygen consumption, and so on.)

Leon et al. (2001) USA

Type: Nutrition intervention to improve albumin levels Intervention: one session by month during 6 months Objectives: To determine potential barriers for patients and to attempt to overcome and to monitor for improvements in barriers (poor knowledge, poor appetite, needing help shopping or cooking, inadequate HD, and so on.) Format: single Educators: dieticians

N = 52 with low albumin levels CG: yes Randomization: yes

T1: pretest T2: posttest at 6 months

Albumin, C-Reactive Protein (CRP)

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Reference and country

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Table 1 (Continued )

Nozaki et al. (2005) Japan

Sagawa et al. (2001) Japan

Schlatter and Ferrans (1998) USA

Shaw-Stuart and Stuart (2000) USA

Sun et al. (2008) Taiwan

T1: pretest T2: during intervention T3: posttest at 4 weeks T4: posttest at 12 weeks

Daily body weight gain, Daily salt intake

SPE: Differences in the daily body weight gain is significant between T1 and T2 (p < 0.05), T1 and T3 (p < 0.05) CBT: Differences in the daily body weight gain is only significant between T1 and T2 (p < 0.05) (significant tendencies between T1 and T3, T1 and T4) CBT and SPE: # daily salt intake with significant difference between T1 and T2, and T1 and T4 (p < 0.05) No significant difference between SPE and CBT

N = 108 CG: no

T1: pretest during five months before intervention T2: posttest during 5 months

Knowledge on phosphate and phosphate binders, Phosphate

Type: Education on fluid control Background: Cognitive Behavioral Therapy (CBT) Intervention: Education and discussions on dietary habits and factors associated with weight gain associated with CBT techniques (reinforcement, selfcontracting, self-monitoring), period: 6 weeks Format: single Educator: research nurse Type: Education on phosphate Intervention: One intervention with a teaching booklet, an osteodystrophy tool and a medication diary Format: single Educator: nurse

N = 10 noncompliant patients CG: no Randomization: no

T1: pretest at 4 weeks T2: during intervention T3: posttest at 4 weeks

Daily weight gain

At T2: -" *of knowledge (p < 0.001) -# *of phosphate of patients who had elevate phosphate in pre-education (p < 0.05) - No effect on serum phosphate levels in the group overall # of daily weight gain between T1 and T2 (0.25%) Little " between T2 and T3 (0.08%) # *of daily weight gain (p < 0.01)

N = 29 patients with high phosphorus levels CG: no Randomization: no

T1: pretest T2: after intervention

Phosphorus, Calcium, Knowledge

Type: Educational patient compliance program on serum phosphate levels Intervention: Educational program using educational materials, motivational posters, puzzles, games, video, and so on. Period: 3 months Format: group Educator: dietitian Type: Patient Education on phosphate Intervention: Several interventions during 30 minutes to improve knowledge and understanding (complication of hyperphosphoremia, dietetic control, and so on.) Format: single Educator: nurse

N = 81, CG: yes Randomization: not reported

T1: pretest on 3 months T2: on 3 months during interventions T3: posttest on 6 months T1: pretest T2: posttest at 1 month

Serum phosphate levels

N = 50 patients with phosphate level greater than 6.0 mg/dL CG: no Randomization: no

Calcium, Product calcium/ phosphorus, Phosphate predialysis level, Serum parathyroid hormone (PTH).

At T2: - Improvement of calcium level (p < 0.01) - Improvement of knowledge about phosphorus (p < 0.01) - Low phosphorus is associated with high knowledge (r = 0.21; p < 0.05) - No effect on phosphorus level # *of phosphate levels across time within groups (p < 0.05) but non significant between CG and EG

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Reddy et al. (2009) England

N = 22 patients noncompliant CG: no Randomization: yes

Type: Patient education program on salt intake and weight gain Background: Cognitive Behavioral Therapy (CBT) Intervention: 2 conditions according to the group during six weeks: - Standard Patient Education (SPE): Self-management pamphlet that focused on factual nutritional information (kidney function, fluid and salt management, table of water and salt content in food) - CBT: self-management program using a selfmonitoring method, a shaping method, assertion training and response prevention Format: group Educators: nurses Type: Diet education to improve phosphate control Intervention: teaching sessions with audio cassette and booklet during one month Format: group Educators: dietitian and interpreter

At T2: - Improvement of phosphate (p < 0.05), of product calcium/phosphorus (p < 0.05) - No effect on calcium and PTH

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EG compared to CG: Higher fluid compliance (p < 0.01) # IDWG between 4 times but this result is non significant

EG compared to CG: -Lower phosphate and calcium/ phosphorus product for EG (p < 0.05) - Kt/v, BMI, albumin, aluminum, calcium, PTH: no effect Time effect: CG: " *for phosphate (p < 0.05) and for calcium/phosphorus product (p < 0.05) No time effect for EG

IDWG

Phosphate, Calcium, Product Calcium/ phosphorus, Serum parathyroid Hormone (PTH), Albumin, Aluminum, kt/V1, Weight, Body Mass Index (BMI)

T1: pretest T2: posttest at 1 months T3: posttest at 3 months T4: posttest at 6 months T1: pretest on 4 months T2: posttest at 4 months N = 62 CG: yes Randomization: yes

Yokum et al. (2008) England

Tsay (2003) Taiwan

Type: Education on fluid compliance Background: Theory of self-efficacy (Bandura) Intervention: 12 educative sessions (3 times a week during 4 weeks) based on self-efficacy training, medical information, dietary habits, fluid intake, counseling, goals, and so on. Format: single Educator: nurses Type: Education on phosphate Intervention: 4 sessions (once a month during 4 months) Information, counseling and prescription adjustment of phosphate binders according to meals and monthly blood results Intervention with a ‘‘phosphate management protocol algorithm’’ Format: single Educators: dietitian, physician and researchers

N = 34 patients with high phosphorus CG: yes Randomization: yes

Results Variables Evaluations Sample Intervention description Reference and country

Table 1 (Continued )

Note: HD for hemodialysis, CG for Control Group, EG for Experimental Group, IDWG for Interdialytic Weight Gain. kt/V1 is a way to measure renal dialysis adequacy. Kt/V is defined as the dialyzer clearance of urea (K, in mL/min) multiplied by the duration of the dialysis treatment (t, in min) divided by the urea distribution volume in the body (V, in mL), which is approximately equal to the total body water. * For statistically significant differences.

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were published between 1999 and 2007. The aims of the different interventions were to improve the adaptation of dialysis patients, to help them deal with the stress of the disease while setting up adapted coping strategies2 and to develop self-care skills. The sessions also aimed at improved psychological well-being (quality of life, depression). The assessment was centered on these different outcomes. The interventions were based on behavioral cognitive theories, the transactional theory of stress (Lazarus and Folkman, 1984), on empowerment3 or self-efficacy. Two of these studies opted for individual interventions (Mathers, 1999; Tsay and Hung, 2004) and two for a group design (Lii et al., 2007; Tsay et al., 2005). Interventions were performed by a nurse or by a nurse with a psychologist. The impact of these programs was assessed by a comparison between an experimental group and a control group. The Taiwanese studies were the only ones to use randomized samples. Three studies assessed the short-term effect of the interventions and one assessed the medium-term effect (Tsay et al., 2005). All interventions demonstrated quite positive results, e.g. decreasing depressive affects (3/3) and perceived stress (1/1) or an improvement in self-efficacy (2/2). With regard to mental quality of life, one study out of the two (1/2) found an improvement after TPE programs. All results are presented in Table 2. 3.4. Evaluation of TPE programs based on combined criteria This part concerns studies that associate physiological and psychosocial outcomes in their evaluation about impact of TPE programs. Thirteen articles were concerned (13/35) (Table 3). The oldest articles dated back to 1981 and the most recent ones to 2008. However, the majority of studies were published in the 2000s. Eight studies were carried out in the United States. The others concerned Europe (n = 4) or Asia (n = 1). The medical and biological outcomes were based of biological and clinical criteria of adherence, knowledge, physical adaptation, self-care skills and the physical quality of life of dialysis patients. Psychological outcomes addressed psychosocial skills and self-efficacy, autonomy, mental quality of life, anxious and depressive symptoms, and social support. Most of the studies opted for psycho-educational interventions and few for a strictly educational content. These studies were based on behavioral cognitive theory, on the transtheoretical model of change, counseling or motivational techniques, empowerment or theory of self-efficacy. Individual programs predominated (8/13). A majority of educational programs were performed by a nurse or by a dietician (7/ 13). Others concerned multidisciplinary teams, psychotherapists, exercise counselors, social workers, medical staff or researchers. Eleven studies included a control group and used randomized samples, except one study for which randomization was not reported (Painter et al.,

2 Coping strategies are all the reactions and strategies utilized by patients to deal with stressful situations (Lazarus and Folkman, 1984). 3 Empowerment is ‘‘the process of enabling people to increase control over, and to improve, their health’’. It is the way by which the individual sets up behaviors that promote self-esteem, self-confidence, autonomy and self-control (Eisen, 1994).

Table 2 Characteristics of quantitative studies reviewed with psychosocial assessment of TPE programs (ranked in alphabetical order). Intervention description

Sample

Evaluations

Variables

Results

Type: Psychoeducational interventions Background: cognitive-behavioral therapy and self-efficacy theory Intervention: 8 sessions (2 h) over a period of 2 months based on cognitive-behavioral techniques. Format: group Educator: dialysis nurse and education nurse Type: Psychosocial education on elderly patients’ adaptation Intervention: 7 sessions with 7 audiotapes and a companion text module, provided information (domestic tranquility, sexuality, social support) 2 days a week over a period of 4 1/2 weeks Format: single Educator: researcher Type: Education program based on empowerment Background: Empowerment Intervention: Active education for helping patients develops skills and self-awareness in goal-setting, problem-solving, self-management, coping, social support, motivation about selfcare. 3 days a week over a period of 4 weeks Format: single Educator: nurse Type: Effect of an adaptation training program Background: transactional theory of stress and coping (Lazarus and Folkman) and cognitive behavioral therapy Intervention: Education and stress management, self-care, coping strategies for dealing with illness stressors (food choice, thirst, fatigue, and so on.) with different techniques (mental imagery, music therapy, relaxation, and so on.) 1 day a week (1 h) over a period of 8 weeks Format: group Educators: nurse and psychotherapist

N = 48 CG: yes Randomization: no

T1: pretest T2: posttest at 1 months

Self-care self-efficacy to HD treatment (coping, stress, making decisions, and so on.), Depression, Physical and mental QoL

At T2: Improvement for EG compared to CG for self-efficacy (p < 0.001), depression (p < 0.001) and physical QoL (p < 0.01) No effect on mental QoL

N = 10 CG: yes Randomization: no

T1: pretest 1 week before T2: posttest at 30 days

Psychosocial adjustment (social support networks, health care, sexuality, self-esteem, domestic tranquility, vocational adjustment, recreation)

At T2: No significant difference between EG and CG, except for ‘‘domestic tranquility’’ (p < 0.05): adjustment was higher for EG

N = 50 CG: yes Randomization: yes

T1: pretest T2: posttest at 6 weeks

Empowerment, Self-care self-efficacy to HD treatment (coping, stress, making decisions, and so on.), Depression

At T2 Improvement for EG compared to CG: Higher empowerment (p < 0.001), higher self-care selfefficacy (p < 0.01), lower depression (p < 0.05)

N = 57 CG: yes Randomization: yes

T1: pretest T2: posttest at 3 months

Depression, QoL, Perceived stress

For EG at T2: - # *perceived stress (p < 0.05) - # *depression (p < 0.001) - improvement *of physical QoL (p < 0.05) - improvement *of mental QoL (p < 0.001) For CG at T2: - " *depression (p < 0.001) - # *physical QoL (p < 0.05) Significant improvements for EG compared to CG: lower depression, lower perceived stress, higher mental QoL and higher physical QoL (p < 0.05)

Mathers (1999) USA

Tsay and Hung (2004) Taiwan

Tsay et al. (2005) Taiwan

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Reference and country Lii et al. (2007) Taiwan

Note: CG for Control Group, EG for Experimental Group, QoL for Quality of Life. * Statistically significant differences.

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Table 3 Characteristics of quantitative studies reviewed with medical and psychosocial assessment of TPE programs (ranked in alphabetical order). IIntervention description

Sample

Evaluations

Variables

Results

Type: Interventions to avoid missed or shortened HD sessions Background: Transtheoretical model of behavioral change (Prochaska and Di Clemente) and cognitive-behavioral theory Intervention: 3 type of interventions G1: video instructions G2: didactic teaching G3: social working group with cognitivebehavioral interventions and motivational interviewing Format: group Educators: nurses for G1 and G2; social workers for G3 Type: Intervention with mutual support Background: Empowerment concept Intervention: 8 group sessions per month (2 h) during 3 months with empowerment techniques and peer social support Format: group Educator: researchers and social worker

N = 28 CG: no Randomization: no

T1: pretest T2: posttest at 30 days T3: posttest at 60 days T4: posttest at 3 months T5: posttest at 6 months

Number of missed HD treatments, Number of shortened HD treatments, Depression, QoL

At T4: # *of missed and shortened HD sessions for the 3 groups (higher decrease for G3) At T5: # *of missed and shortened HD sessions only for G3 G3: Missed HD sessions at 3 months (T4) were associated with missed HD sessions at 6 months (T5) (r = .867, p < 0.01) G3: " QDV and # depression

N = 15 CG: no Randomization: no

T1: pretest T2: posttest at 2 weeks

Physical symptoms, Social support, Psychological QoL

At T2: - Decrease in physical symptoms (p < 0.01): # spasms (p < 0.05), # thirst (p < 0.01), #‘‘chest tightness’’(p < 0.05); - Increase of social support for all dimensions (p < 0.001); - Increase of QoL (p < 0.001). Diet compliance at T2: - lower potassium serum for G1 and G2 compared to CG (p < 0.05) No significant difference between G1, G2 and G3 Fluid compliance at T2: lower IDWG for G2 compared to CG (p < 0.05) Diet and fluid compliance at T3: no significant difference between G1, G2 and G3 Higher health beliefs about barriers were associated with noncompliance (p < .05) At T2: higher knowledge, understanding and beliefs for EG compared to CG (p < 0.05) At T3: higher understanding for EG compared to CG (p < 0.05) At T4: higher understanding (p < 0.05) and knowledge (p < 0.01) for EG compared to CG No effects on medication adherence self-report and blood phosphate levels

Chen et al. (2008) Taiwan

Cummings et al. (1981) USA

Type: Intervention to improve compliance with medical regimen Intervention: 3 intervention groups: G1: behavioral contracting with a nurse G2: behavioral contracting with a nurse and a family member or friend G3: weekly telephone contact Period: 6 weeks Format: single Educator: nurse

N = 87 CG: yes Randomization: yes

T1: pretest T2: posttest at 6 weeks T3: posttest at 3 months

Health beliefs about noncompliance, about barriers and benefits, Potassium, IDWG

Karamanidou et al. (2008) England

Type: Psycho-educational intervention on phosphorus Background: Self-regulatory theory-based Intervention: interactive intervention with leaflet and demonstration of mode of action of treatment to improve patients’ understanding Format: group Educator: psychologist investigator

N = 39 CG: yes Randomization: yes

T1: pretest T2: posttest after intervention T3: posttest at 1 months T4: posttest at 4 months

Phosphate knowledge, Phosphate understanding, Treatment beliefs, Medication adherence selfreport, Blood phosphate levels

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Reference and country Cabness et al. (2007) USA

Type: Education and support program on patients’ physical and psychosocial adaptation Intervention: 12 sessions during 3 months based on self-care concept and different actions (support, coping strategies, and so on.) Format: individual Educator: nurse

N = 135 CG: yes Randomization: yes

T1: pretest T2: posttest at 3 months T3: posttest at 6 months T4: posttest at 1 year

Kutner and Brogan (1981) USA

Type: Education program for new dialysis patients Intervention: 2 informational sessions about (1) kidney disease, dialysis and diet management; and (2) vocational issues and family/personal adjustment issues Format: group Educators: nurse, dietician, psychiatric social worker, vocational rehabilitation counselor

N = 15 CG: yes Randomization: yes

T1: pretest T2: posttest at 2 months

McMurray et al. (2002) USA

Type: Diabetes education and care management for dialysis patients Intervention: Education based on selfmanagement and self-monitoring (glycemic control, foot checks annual eye examination, and so on.) and nutritional counseling et motivational counseling During HD treatment and for a oneyear period Format: single Educators: renal dietitian and diabetes care manager Type: Nutritional education on fluid compliance Background: Transtheoretical model of behavioral change (Prochaska and Di Clemente) Intervention: Sessions are developed according stage of change (preaction and action) with educational strategies Period: 12 weeks Format: single Educator: dietician Type: Education on physical activity Intervention: (1) First time: independent home exercise (individualized program) during 8 weeks (flexibility, strengthening, cardiovascular exercises, and so on.) (2) Second time: in-center cycling during dialysis during 8 weeks Format: single Educator: medical staff

N = 83 CG: yes Randomization: yes

T1: pretest T2: posttest at 1 year

N = 316 CG: yes Randomization: yes

T1: pretest T2: posttest at 6 weeks T3: posttest at 12 weeks

Stages of change, Knowledge, IDWG

N = 286 CG: yes Randomization: not reported

T1: pretest T2: posttest after first session T3: posttest after second session

Physical function testing (gait speed, sit-to-stand-to-sit test, 6-minutes walk), QoL

Molaison and Yadrick (2003) USA

Painter et al. (2000) USA

At T3 and T4: -Improvement of physical and psychosocial adaptation for EG (p < 0.05) -No significant difference between EG and CG

Improved results for EG compared to CG at T2: - Higher knowledge for EG (p < 0.01) - " of self-reported compliance, # anxiety, # depression, " satisfaction for EG compared to CG but non significant

Improved results for EG compared to CG at T2: - Higher knowledge (p < 0.001) - Higher QoL for diabetes symptoms (p < 0.001) and health perception (p < 0.01) - Improvement of hemoglobin A1c (p < 0.01) - Improvement of frequency of self-care behaviors (p < 0.05) - Mental QoL: no effect EG compared to CG at T3: - Positive evolution of stage’s change - " *knowledge (30%) (p < 0.001) No decrease of IDWG

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Ability to perform daily activities, Changes in social functioning, Regimen compliance, Ability to function in society and cope with chronic disease, Alienation feeling Powerlessness, Normlessness, Social isolation Knowledge; Self-reported Compliance (fluid, diet, medication, IDWG); Anxiety; Depression; Satisfaction with current feeling about themselves and their life; Locus of control Diabetes knowledge, Frequency of self-care Behaviors, Diabetes QoL, Foot assessments, Blood tests

Korniewicz and O’Brien (1994) USA

EG compared to CG at T3: - Improvement on physical function (gait speed (p < 0.05) and sit-to-standto-sit test (p < 0.05)) - Improvement of QOL: physical component (p < 0.01), role physical (p < 0.001), general health (p < 0.05), bodily pain (p < 0.01), - Mental QoL: no effect

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IIntervention description

Sample

Evaluations

Variables

Results

Type: Education on fluid compliance Background: Cognitive behavioral therapy Intervention: 4 sessions (period of 4 weeks) with educative strategies (information on fluid restrictions), behavioral strategies (skills, selfmanagement, self-control, and so on.) and cognitive strategies (associations between thoughts/emotions/behaviors) Format: group Educator: cognitive behavioral therapist

N = 56 patients fluid noncompliant CG: yes Randomization: yes

T1: pretest T2: posttest after the last intervention T3: posttest at 10 weeks

IDWG, Anxiety, Depression, QoL, Health beliefs and attributions associated with fluid restrictions

Tanner et al. (1998) England

Type: Effect of a self-monitoring tool on selfefficacy, health belief and adherence Intervention: self-monitoring tool, flashcards, contract, goals during 6 months Format: single Educator: dietician

N = 40 patients identified as noncompliant to fluid and phosphate CG: yes Randomization: yes

T1: pretest T2: posttest at 6 months

IDWG, Phosphorus, Self-efficacy, Health beliefs Knowledge

Tawney et al. (2000) USA

Type: Education on physical activity Intervention: ‘‘The Life Readiness Program Intervention’’ based on 9 sessions of counseling with educational material. 6 months-period and during HD treatment Goal: 15–30 min of physical activity per day (walk with the dog, taking the stair, walking, cycling, and so on.). Format: single Educator: dietician

N = 82 CG: yes Randomization: yes

T1: pretest T2: posttest at 6 months.

General QoL (10 scales), Kidney disease QoL (10 scales) Physical activity,

Van Vilsteren et al. (2005) Netherlands

Type: Education on physical activity Background: Transtheoretical model of behavioral change (Prochaska and Di Clemente) Intervention: Exercise program (pre-dialysis strength training and cycling program during dialysis) and exercise counseling Period: 12 weeks Format: single. Educators: Exercise counselors.

N = 96 CG: yes Randomization: yes

T1: pretest T2: posttest at 12 weeks

Physical fitness (exercise capacity, extremity muscle, reaction time, and so on.), QoL, Depression, Physical condition (weight, Kt/V, heart rate, systolic blood pressure; cholesterol; hematocrit; hemoglobin), Behavioral change

At T2: - Improvement of QoL for EG compared to CG for mental health (p < 0.05) and role-emotional (p < 0.01) - Improvement of attribution for EG compared to CG (p < 0.01) At T3 (data combined from both groups): - *reduction of IDWG (p < 0.001) - Improvement of attribution (p < 0.05) - Improvement of health beliefs (p < 0.001) - No effect on depression, anxiety and several scales of QoL (physical function, role physical, bodily pain, general health, vitality, social function) At T2, EG compared to CG: - improvement of knowledge for EG (p < 0.01) - no effect on self-efficacy, health beliefs, phosphorus level and IDWG. Precision at 3 months: - lower phosphorus for EG (p < 0.01) EG compared to CG at T2: - Higher physical functioning (QoL) for EG (p < .10) - Higher physical activity time for EG (p < 0.05) No effect on other scales of general QoL (mental health, vitality, general health, bodily pain, role-physical, role emotional, social function, mental QoL, physical QoL) and specific kidney disease QoL Improved results for EG compared to CG at T2: - time reaction (p < 0.01) - muscle strength (p < 0.05) - vitality (QoL) (p < 0.001) - general health perception (QoL) (p < 0.001) - health change (QoL) (p < 0.05) - Kt/V (p < 0.05) - Evolution of stage of change (p < 0.01) No effect on several scales of QoL (physical functioning, social functioning, role-physical, mental health, pain); no effect on depression; weight; systolic blood pressure; cholesterol; hematocrit; hemoglobin.

Note: HD for hemodialysis, CG for Control Group, EG for Experimental Group, QoL for Quality of Life, IDWG for Interdialytic Weight Gain. * Statistically significant differences.

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Reference and country Sharp et al. (2005b) England

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Table 3 (Continued )

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2000). Two studies included only patients with adherence difficulties (Sharp et al., 2005b; Tanner et al., 1998). Medium-term assessment was the most frequent. Only two studies assessed the program in the long term (one year) (Korniewicz and O’Brien, 1994; McMurray et al., 2002). All studies showed at least one beneficial effect (Table 3). As far as adherence with biological and clinical criteria is concerned, there was a decrease in interdialytic weight gain in two studies (2/4). A decrease in potassium (1/1) and phosphorus (1/2) was demonstrated in one study only in the short term. There was a decreasing number of shortened or missed dialysis sessions in one study (1/1) (Cabness et al., 2007). Clinical criteria regarding physical activity were assessed by each study (3/3) that offered a TPE program on physical activity (Painter et al., 2000; Tawney et al., 2000; Van Vilsteren et al., 2005). TPE programs seemed to be effective with regard to physical quality of life because five studies out of the six found an improvement in this outcome. The patients’ knowledge and understanding of their condition increased after all programs (5/5). However, an increase in knowledge was not always associated with better therapeutic adherence or clinical and/or psychological state (Karamanidou et al., 2008; Kutner and Brogan, 1981; Molaison and Yadrick, 2003). As far as psychosocial outcomes are concerned, only three studies out of the seven noted an improvement in mental quality of life (Cabness et al., 2007; Chen et al., 2008; Sharp et al., 2005b). Decreased anxiety and/or depression after interventions were demonstrated by only two studies out of four (Cabness et al., 2007; Kutner and Brogan, 1981). Other positive psychosocial effects were also shown such as an increased social support (1/1) (Chen et al., 2008), a change in health beliefs (3/4) (Cummings et al., 1981; Karamanidou et al., 2008; Sharp et al., 2005b) and an evolution in stages of change (2/2) (Molaison and Yadrick, 2003; Van Vilsteren et al., 2005). No effect was observed with regard to self-efficacy (0/1) and locus of control (0/1). All results are reported in Table 3. 4. Discussion and conclusion 4.1. Discussion This systematic review throws light on TPE interventions and their impact on patients undergoing dialysis. It shows that research on TPE is worldwide, being performed especially in the United States, Asia and Europe. Moreover, of the global heading ‘TPE’ covers a very wide range of interventions. As previous reviews underlined the positive effect of TPEs on patients’ adherence, this review clarifies its effect on both medical and psychosocial outcomes. In 2008, the last systematic review by Mason et al. found 17 papers on the subject but they included only randomized studies. Our systematic review of 35 articles describing studies randomized or not shows that TPE programs are gaining ground in hemodialysis. We found that most interventions are done by one health professional, especially a nurse and (less frequently) a dietician. This is probably due to the fact that most TPE interventions focus on improving adherence to nutritional guidelines. Nurses have a crucial role to play for dialysis

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patients globally and in TPE. They are often concerned by the acquisition of autonomy, hygiene, self-care skills and adaptation skills. For example, nurses can work with patients to assemble the dialysis machine, to choose safety behavior when the patient is faced with a problematic situation (bleeding on vascular access, thrombosis of vascular access), and to adopt protective behavior on a daily basis. The relationship between nurse and patient is specific especially in dialysis, because patients are treated three times a week. It is in the nurse that they often confide their difficulties first. However, the role of each health professional (physician, nurse, dietician, pharmacist, psychologist, social worker, etc.) is very important and complementary. For example, a distressed patient is not always able or motivated enough to change his behavior, even when he is well aware of his disease. Not adhering to recommendations can be a sign of distress or nonacceptance of the disease. In that event, the intervention of a psychologist in TPE is complementary with the intervention of the nurse, dietician or physician. It reinforces the psychosocial support specified in the definition by the World Health Organization (1994). The expertise of each professional is important to create a TPE program for dialysis and to organize or conduct specific activities. Multidisciplinary teams in TPE can promote the acquisition of several skills (self-care skills as adherence and psycho-social skills). Another important aspect of TPE programs is that most of them are composed of individual sessions. This format promotes a closer relationship, enabling problems specific to each patient to be tackled. However, they are timeconsuming. TPE with group sessions allows stimulation and confrontation of viewpoints as well as promoting mutual aid and solidarity. It also improves interactivity and group dynamics. Research in social psychology has shown the benefits of work in small groups. Individuals can more easily change their beliefs and their behavior when in small groups rather than when alone. Of course, each method has its advantages and drawbacks. Only two studies in this review focused on individual and collective activities, and demonstrated that the association led to good results (Baraz et al., 2010; Konstantinidou et al., 2002). Therefore, the most rational approach would be to include both in TPE programs. More beneficial effects would be observed if dialysis patients were offered a TPE program associating collective and individual sessions. Several interventions only included dialysis patients who did not adhere to food or fluid recommendations. This methodology is debatable since there is more chance of finding positive results of TPE with non-compliant patients. However, every patient may need and be interested in an educational program to understand the various aspects of the disease or treatment. The positive results in studies with ‘‘run-of-the-mill’’ patients confirm this point of view. From a practical point of view and to gather a maximum of data, it is interesting to group together patients with different medical experiences, thereby exploring a wider range of hands-on experience. Furthermore, health messages sometimes have greater impact when they are given by an expert patient rather than by health professionals.

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Out of the thirty-five studies selected, most of them assessed physiological outcomes (18/35). Most of these studies show the positive effects of TPE on adherence. However, TPE cannot be limited to issues of adherence and assessed with biological and clinical indicators. Similarly, assessing only psychological impact is restrictive. Neither of the two types of assessment considers the patient as a whole. As mentioned above, TPE is a global technique that focuses on the physiological (clinical, biological, physical) and psychological well-being of the patient. In this respect, studies taking into account both physiological and psychosocial outcomes are of great interest. According to Welch and Thomas-Hawkins (2005), including psychosocial variables (exploratory, intermediate or comparative) would enable better comprehension of the effects linked with a TPE program for dialysis patients. However, including physiological variables is also important to assess adherence to therapeutic recommendations. However, the assessment of the impact of TPE programs on adherence is possible by combining biological/clinical criteria (objective measure) and psychosocial criteria with self-reported compliance (subjective measure). All of the studies examined underline the relevance of TPE interventions for dialysis patients, as they all showed one or several beneficial effects. However, sometimes results were significant just for the experimental group while some of them were not when compared with the control group. A few studies showed a maintained or improved psychological quality of life and an attenuated state of anxiety and depression (Cabness et al., 2007; Chen et al., 2008; Kutner and Brogan, 1981; Lii et al., 2007; Tsay and Hung, 2004; Tsay et al., 2005). Though not all TPE programs showed improved mental quality of life or less anxiety/depression (McMurray et al., 2002; Lii et al., 2007) particularly those focusing specifically on physical activity (Painter et al., 2000; Tawney et al., 2000; Van Vilsteren et al., 2005). The effect of TPE was especially varied regarding physiological variables such as improved adherence of food and fluid restriction but the tendency seemed to be that the majority of TPE programs improve adherence. Physical quality of life is often better after TPE intervention. Results on adherence should be taken with caution as the way adherence is assessed differed from one study to another. In fact, there is no consensus about what adherence actually means and how it can be measured. Knowledge was improved after the intervention in all studies that investigated this parameter (Brantley et al., 1990; Deimling et al., 1984; Ford et al., 2004; Karamanidou et al., 2008; Kutner and Brogan, 1981; McMurray et al., 2002; Molaison and Yadrick, 2003; Reddy et al., 2009; Tanner et al., 1998; Schlatter and Ferrans, 1998). However, better knowledge does not always lead to greater adherence and it may not be enough to alter patients’ behavior (Kaptein et al., 2010; Morgan, 2000; Sun et al., 2008). This shows how important it is to examine psychosocial variables in order to understand better the process of change or non-change in TPE. The time and number of TPE interventions were variable. The number ranged from 1 to 21 sessions and the time from one session to one year. This variability could explain the lack of effect in some studies, in

particular with regard to adherence. A single educational session is generally insufficient to help the patient to acquire several skills and knowledge (Deimling et al., 1984; Karamanidou et al., 2008; Schlatter and Ferrans, 1998). TPE is a continuous process, especially when the educational objectives are numerous. For example, Sun et al. (2008) chose not to limit the number of sessions but to repeat them until their patients acquired the necessary knowledge and educational skills with regard to dietary recommendations about phosphorus. This strategy led to improved adherence regarding these recommendations. Ideally, the number of educational sessions should be adapted to patients’ rhythms of learning and memorization and to their different needs. However in practice, lack of time, support and infrastructure often limits the number of TPE sessions, the duration of the program and the assessment. All the studies highlighted short-term effects that did not always persist in the medium or long term. Two studies only tested the impact of their interventions after a year (Brantley et al., 1990; Korniewicz and O’Brien, 1994). Long-term assessment seems relevant, yet it is unsure exactly what is assessed when the interventions stopped months before. To what extent are the effects of the TPE program really being assessed, and are classical care and consultations with the different health professionals of the units also having an impact? The fact that some effects may not last in time may be linked to a loss of motivation or else to minor or major life events affecting the patient. In the course of a year, many external or internal factors may affect the medical or psychological conditions of the patient and hence influence his outcome for better or for worse. One of the main objectives of TPE is to maintain effects over time. Since TPE is a continuous process, it presupposes regular assessment of its benefits and renewal, if necessary, of the interventions. Alternatively, it may entail offering new interventions to deal with the patient’s difficulties, requests and events that affect his life. Our review has two main methodological limitations. First, a meta-analysis should ideally have been carried out in order to underline the effects of TPE. However, as the studies presented are very different from one another in terms of content, background, educational tools, educators, design, time intervals between interventions, duration of assessment, assessment tools, and so on, we preferred to review the literature. Secondly, we decided to include studies that did not involve control groups or randomized samples. To scientifically assess a TPE program, standardized and randomized interventions should ideally be investigated. However, in practice, such a methodology is difficult to set up and may give the impression of keeping a distance from the patient and not taking his needs into account, which goes against the recommendations for TPE. 4.2. Conclusion and practice implication This systematic review based on hemodialysis patients shows that most studies evaluated physiological outcomes. However, psychological outcomes combined with

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physiological measurement are of great value as far as practice and research are concerned. Nurses can undertake multidisciplinary assessment to better understand the impact of TPE. The review shows that educational interventions have several positive effects. This is encouraging for nurses to develop TPE programs for dialysis patients in their multidisciplinary teams. Nurses have an important role to play in TPEs since they are the most frequent educators in dialysis programs, as attested by this review. Therefore, their role and skills must be varied: communication skills, educational and animation skills, ability to work in interaction with other health professionals and understanding the effects of TPEs. In summary, the findings of this systematic review suggest the need for the following: - To set up multidisciplinary, collective and individual interventions. - To assess TPE programs with physiological (biological and clinical) and psychosocial outcomes (combined criteria) in order to improve understanding of the effects of TPEs. - To apply more rigorous methodologies in terms of control groups and randomization so as to obtain more reliable scientific results, especially in the long term after intervention. However, this might be complicated because TPE is an ongoing process.

Conflict of interest There are no conflicts of interest with this review. Acknowledgments With many thanks to Ray Cooke for revising the English and to Roche Pharma for financial support for the doctoral dissertation on Therapeutic Education for patients in hemodialysis. References Albano, M.G., Crozet, C., D’Ivernois, J.F., 2008. Analysis of the 2004–2007 literature on therapeutic patient education in diabetes: results and trends. Acta Diabetologica 45, 211–219. Ashurst, I.B., Dobbie, H., 2003. A randomized controlled trial of an educational intervention to improve phosphate levels in hemodialysis patients. Journal of Renal Nutrition 13, 267–274. Bandura, A., 1997. Self-Efficacy: The Exercise of Control. Freeman and Co, New York. Baraz, S.H., Parvardeh, S., Mohammadi, E., Broumand, B., 2010. Dietary and fluid compliance: an educational intervention for patients having haemodialysis. Journal of Advanced Nursing 66, 60–68. Barnett, T., Yoong, L.Y., Pinikahana, J., Si-yen, T., 2007. Fluid compliance among patients having haemodialysis: can an educational programme make a difference? Journal of Advanced Nursing 61, 300–306. Bleyer, A.J., Hylander, B., Sudo, H., Nomoto, Y., De La Torre, E., Chen, R.A., et al., 1999. An international study of patient compliance with hemodialysis. Journal of American Medical Association 281, 1211–1213. Bowling, A., 2002. Research Methods in Health: Investigating Health and Health Services, 2nd ed. Open University Press, Buckingham/Philadelphia. Brantley, P.J., Mosley, H., Bruce, B.K., McKnight, G.T., Jones, G.N., 1990. Efficacy of behavioral management and patient education on vascular access cleansing compliance in hemodialysis patients. Health Psychology 9, 103–113.

1585

Cabness, J., Miller, C., Martina, K., 2007. Mastering hemodialysis to reverse patterns of missed and shortened treatments. Journal of Nephrology Social Workers 27, 45–51. Casey, J., Johnson, V., McClelland, P., 2002. Impact of stepped verbal and written reinforcement of fluid balance advice within an outpatient haemodialysis unit: a pilot study. Journal of Human Nutrition Dietetics 15, 43–47. Chen, Y.C., Pai, J.S., Li, I.C., 2008. Haemodialysis: the effects of using the empowerment concept during the development of a mutual-support group in Taiwan. Journal of Nursing Healthcare Chronic Illness 17, 133–142. Christensen, A.J., Moran, P.J., Wiebe, J.S., Ehlers, S.L., Lawton, W.J., 2002. Effect of a behavioural self-regulation intervention on patient adherence in hemodialysis. Health Psychology 21, 393–397. Cukor, D., Coplan, J., Brown, C., Friedman, S., Newville, H., Safier, M., et al., 2008. Anxiety disorders in adults treated by hemodialysis: a singlecenter study. American Journal of Kidney Diseases 52, 128–136. Cummings, K.M., Becker, M.H., Kirscht, J.P., Levin, N.W., 1981. Intervention strategies to improve compliance with medical regimens by ambulatory hemodialysis patients. Journal of Behavioral Medicine 4, 111–127. Deimling, A., Denny, M., Harrison, M., et al., 1984. Effect of an algorithm and patient information on serum phosphorus levels. American Association of Nephrology Nurses & Technicians 11, 35–38. Eisen, A., 1994. Survey of neighborhood-based, comprehensive community empowerment initiatives. Health Education Quarterly 21, 235–252. Ford, J.C., Pope, J.F., Hunt, A.E., Gerald, B., 2004. The effect of diet education on the laboratory values and knowledge of hemodialysis patients with hyperphosphatemia. Journal of Renal Nutrition 14, 36–44. Fukuhara, S., Lopes, A.A., Bragg-Gresham, J.L., Kurokawa, K., Mapes, D.L., Akizawa, T., et al., 2003. Health-related quality of life among dialysis patients on three continents: the dialysis outcomes and practice patterns study. Kidney International 64, 1903–1910. Gay, C., Cuche, H., 2006. The role of psychoeducational measures in the care of bipolar disorders. Ence´phale 32, 542–546. Hecking, E., Bragg-Gresham, J.L., Rayner, H.C., Pisoni, R.L., Andreucci, V.E., Combe, C., et al., 2004. Haemodialysis prescription, adherence and nutritional indicators in five European countries: results from the dialysis outcomes and practice patterns study (DOPPS). Nephrology Dialysis and Transplantation 19, 100–107. Kaptein, A.A., van Dijk, S., Broadbent, E., Falzon, L., Thong, M., Dekker, F.W., 2010. Behavioural research in patients with end-stage renal disease: a review and research agenda. Patient Education and Counseling 81, 23–29. Karamanidou, C., Weinman, J., Horne, R., 2008. Improving haemodialysis patients’ understanding of phosphate-binding medication: a pilot study of a psycho-educational intervention designed to change patients’ perceptions of the problem and treatment. British Journal of Health Psychology 13, 205–214. Konstantinidou, E., Koukouvou, G., Kouidi, E., Deligiannis, A., Tourkantonis, A., 2002. Exercise training in patients with end-stage renal disease on hemodialysis: comparison of three rehabilitation programs. Journal of Rehabilitation of Medicine 34, 40–45. Korniewicz, D.M., O’Brien, M.E., 1994. Evaluation of a hemodialysis patient education and support program. American Nephrology Nurses’ Association 21, 33–38. Kimmel, P.L., Peterson, R.A., 2005. Depression in end-stage renal disease patients treated with hemodialysis: tools, correlates, outcomes, and needs. Seminars of Dialysis 18, 91–97. Kutner, N.G., Brogan, D.R., 1981. Evaluation of an experimental education program for new dialysis patients. American Association of Nephrology Nurses & Technicians 9, 22–25. Lazarus, R.S., Folkman, S., 1984. Stress, Appraisal and Coping. Springer, New York. Leon, J.B., Majerle, A.D., Soinski, J.A., Kushner, I., Ohri-Vachaspati, P., Sehgal, A.R., 2001. Can a nutrition intervention improve albumin levels among hemodialysis patients? A pilot study. Journal of Renal Nutrition 11, 9–15. Lii, Y.C., Tsay, S.L., Wang, T.J., 2007. Group intervention to improve quality of life in haemodialysis patients. Journal of Nursing Healthcare Chronic Illness 16, 269–275. Mason, J.O., Khunti, K., Stone, M., Farooqui, A., Carr, S., 2008. Educational interventions in kidney disease care: a systematic review of randomized trials. American Journal of Kidney Diseases 51, 933–955. Mathers, T.R., 1999. Effects of psychosocial education on adaptation in elderly hemodialysis patients. American Nephrology Nurses’ Association 26, 587–589. McMurray, S.D., Johnson, G., Davis, S., McDougall, K., 2002. Diabetes education and care management significantly improve patient

1586

L. Idier et al. / International Journal of Nursing Studies 48 (2011) 1570–1586

outcomes in the dialysis unit. American Journal of Kidney Diseases 40, 566–575. Molaison, E.F., Yadrick, M.K., 2003. Stages of change and fluid intake in dialysis patients. Patient Education and Counseling 49, 5–12. Morgan, L., 2000. A decade review: methods to improve adherence to the treatment regimen among hemodialysis patients. Nephrology Nursing Journal 27, 299–304. Nozaki, C., Oka, M., Chaboyer, W., 2005. The effects of a cognitive behavioural therapy programme for self-care on haemodialysis patients. International of Journal Nursing Practice 11, 228–236. Painter, P., Carlson, L., Carey, S., Paul, S.M., Myll, J., 2000. Physical functioning and health-related quality of life changes with exercise training in hemodialysis patients. American Journal of Kidney Diseases 35, 482–492. Prochaska, J., Di Clemente, C.C., 1992. The Transtheoretical Approach: Grossing the Traditional Boundaries of Therapy. Homewood, IL. Reddy, V., Symes, F., Sethi, N., Scally, A.J., Scott, J., Mumtaz, R., Stoves, J., 2009. Dietitian-led education program to improve phosphate control in a single-center hemodialysis population. Journal of Renal Nutrition 19, 314–320. Rosenstock, I.M., 1974. The health belief model and preventive health behavior. Health Education Monographs 35–86. Sagawa, M., Oka, M., Chaboyer, W., Satoh, W., Yamaguchi, M., 2001. Cognitive behavioural therapy for fluid control in haemodialysis patients. Nephrology Nursing Journal 28, 37–39. Saran, R., Bragg-Gresham, J.L., Rayner, H.C., Goodkin, D.A., Keen, M.L., Van Dijk, P.C., et al., 2003. Nonadherence in hemodialysis: associations with mortality, hospitalization, and practice patterns in the DOPPS. Kidney International 64, 254–262. Schlatter, S., Ferrans, C.E., 1998. Teaching program effects on high phosphorus levels in patients receiving haemodialysis. American Nephrology Nurses’ Association 25, 31–35. Sharp, J., Wild, M.R., Gumley, A.I., 2005a. A systematic review of psychological interventions for the treatment of nonadherence to fluidintake restrictions in people receiving hemodialysis. American Journal of Kidney Diseases 45, 15–27. Sharp, J., Wild, M.R., Gumley, A.I., Deighan, C.J., 2005b. A cognitive behavioral group approach to enhance adherence to hemodialysis

fluid restrictions: a randomized controlled trial. American Journal of Kidney Diseases 45, 1046–1057. Shaw-Stuart, N.J., Stuart, A., 2000. The effect of an educational patient compliance program on serum phosphate levels in patients receiving hemodialysis. Journal of Renal Nutrition 10, 80–84. Sun, C.Y., Chang, K.C., Chen, S.H., Chang, C.T., Wu, M.S., 2008. Patient education: an efficient adjuvant therapy for hyperphosphatemia in hemodialysis patients. Renal failure 30, 57–62. Tanner, J.L., Craig, C.B., Bartolucci, A.A., et al., 1998. The effect of a selfmonitoring tool on self efficacy, health beliefs, and adherence in patients receiving hemodialysis. Journal of Renal Nutrition 8, 203–211. Tawney, K.W, Tawney, P.J., Hladik, G., et al., 2000. The life readiness program: a physical rehabilitation program for patients on hemodialysis. American Journal of Kidney Diseases 36, 581–591. Tsay, S.L., 2003. Self-efficacy training for patients with endstage renal disease. Journal of Advanced Nursing 43, 370–375. Tsay, S.L., Hung, L.O., 2004. Empowerment of patients with end-stage renal disease – a randomized controlled trial. International Journal of Nursing Studies 41, 59–65. Tsay, S., Lee, Y., Lee, Y., 2005. Effects of an adaptation training programme for patients with end-stage renal disease. Journal of Advanced Nursing 5, 39–46. Van Vilsteren, M.C., de Greef, M.H., Huisman, R.M., 2005. The effects of a low-to-moderate intensity pre-conditioning exercise programme linked with exercise counselling for sedentary haemodialysis patients in The Netherlands: results of a randomized clinical trial. Nephrology Dialysis and Transplantation 20, 141–146. Welch, J.L., Thomas-Hawkins, C., 2005. Psycho-educational strategies to promote fluid adherence in adult hemodialysis patients: a review of intervention studies. International Journal of Nursing Studies 42, 597–608. World Health Organization (WHO), 1996. Therapeutic Patient Education, Continuing Education Programmes for Healthcare Providers in the Field of Chronic Disease. , http://www.who.int. Yokum, D., Glass, G., Cheung, C.F., Cunningham, J., Fan, S., Madden, A.M., 2008. Evaluation of a phosphate management protocol to achieve optimum serum phosphate levels in hemodialysis patients. Journal of Renal Nutrition 18, 521–529.