Comparison of family partnership intervention care vs. conventional care in adult patients with poorly controlled type 2 diabetes in a community hospital: A randomized controlled trial

International Journal of Nursing Studies 47 (2010) 1363–1373

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Comparison of family partnership intervention care vs. conventional care in adult patients with poorly controlled type 2 diabetes in a community hospital: A randomized controlled trial Chun-Mei Kang a,b,1, Shu-Chuan Chang c,2, Ping-Ling Chen d,3, Pei-Fen Liu e,1, Wen-Cheng Liu e,4, Chia-Chi Chang f,5, Wen-Yin Chang d,* a

Nursing Department, Cathay General Hospital, Taipei, Taiwan, ROC School of Nursing, Taipei Medical University, No. 280, Renai Rd., Sec. 4, Taipei 106, Taiwan, ROC Hualien Tzu-Chi Medical Center, No. 707, Sec. 3, Chung Yang Rd., Hualien 970, Taiwan, ROC d Graduate Institute of Nursing, College of Nursing, Taipei Medical University, No. 250, Wu-Hsing Street, Taipei 110, Taiwan, ROC e Cathay General Hospital, No. 280, Renai Rd., Sec. 4, Taipei 106, Taiwan, ROC f School of Geriatric Nursing and Care Management, College of Nursing, Taipei Medical University, No. 250, Wu-Hsing Street, Taipei 110, Taiwan, ROC b c

A R T I C L E I N F O

A B S T R A C T

Article history: Received 12 March 2009 Received in revised form 9 March 2010 Accepted 12 March 2010

Background: Although there is a significant correlation between the degree of family support and clinical outcome, little research has focused on the effectiveness of family partnership intervention care (FPIC) for patients with poorly controlled type 2 diabetes. Objectives: This study aimed to compare FPIC with conventional care (CC) across a number of outcome measures in patients with poorly controlled type 2 diabetes. Design: The study was performed using a randomized controlled trial design. Participants: Patients with poorly controlled type 2 diabetes who were solely treated with oral antidiabetic agents and had at least two out of three hemoglobin A1C readings equal to or above 7% in the previous 12 months, were randomly assigned to the FPIC group (n = 28) and to the CC group (n = 28). Methods: Baseline and 6-month follow-up scores were compared using the following outcome measures: (1) hemoglobin A1C, (2) BMI, (3) lipid profile, (4) family supportive behaviours, (5), knowledge of and attitudes toward diabetes, and (6) diabetes self-care behaviours. Descriptive and non-parametric statistics were employed to compare differences in outcome measures between the groups. Results: There were no significant differences in the reduction of hemoglobin A1C levels (p = 0.46), lipid profile values (p > 0.05), and improvement of diabetes self-care behaviours (p = 0.61) between the groups at 6 months post-intervention. However, there were significant differences in the scores of family supportive behaviours (p = 0.031) and patients’ knowledge of and attitudes toward diabetes between the groups (p < 0.05). Conclusion: These findings support the use of FPIC to enhance family supportive behaviours, and to improve patients’ knowledge of and attitudes toward diabetes. Thus, the study is of

Keywords: Type 2 diabetes Hemoglobin A1C Family support Self-care behaviour Knowledge Attitude

* Corresponding author at: Graduate Institute of Nursing, College of Nursing, Taipei Medical University, No. 250 Wu-Hsing Street, Taipei 110, Taiwan, ROC. Tel.: +886 2 27361661x6326; fax: +886 2 23772842. E-mail addresses: [email protected] (C.-M. Kang), [email protected] (S.-C. Chang), [email protected] (P.-L. Chen), [email protected] (P.-F. Liu), [email protected] (W.-C. Liu), [email protected] (C.-C. Chang), [email protected] (W.-Y. Chang). 1 Tel.: +886 2 27082121; fax: +886 2 27097911. 2 Tel.: +886 3 8561825; fax: +886 3 8560977. 3 Tel.: +886 2 27361661x6325; fax: +886 2 23772842. 4 Tel.: +886 2 27318532; fax: +886 2 27218056. 5 Tel.: +886 2 27361661x6336; fax: +886 2 23772842. 0020-7489/$ – see front matter ß 2010 Elsevier Ltd. All rights reserved. doi:10.1016/j.ijnurstu.2010.03.009

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value in helping policy decision-makers to develop more effective diabetes control intervention programmes. ß 2010 Elsevier Ltd. All rights reserved.

What is already known about the topic?  A family-centered approach to diabetes care facilitates positive family functioning, leads to lower levels of stress in family-life, and promotes optimal clinical outcomes.  A nurse education program improves levels of hemoglobin A1C and reduces diabetes related complications in patients with type 2 diabetes.  Lack of knowledge of the diabetes management plan was reported as a barrier to effective treatment by patients with type 2 diabetes. What this paper adds  Patients who participated in the family partnership intervention care group had no significant improvement in glycemic control and values of plasma lipid profiles.  Patients with poorly controlled type 2 diabetes who participate in family partnership intervention care are likely to acquire better knowledge and attitudes toward diabetes.  Family support did not significantly affect patients’ diabetes self-care behaviours. 1. Introduction Diabetes mellitus (DM) is a complex, chronic disease and is a significant public health and economic burden on society. Increased emphasis on preventive strategies and disease management for patients with DM in order to reduce the future global impact on health care is an important component of national health policy for many countries, including Taiwan. To address this issue, the Taiwanese government implemented the National Health Management Plan (NHMP) in 2002 to provide high quality diabetes care to patients with type 2 DM (T2DM) and to reduce the associated medical care costs (Bureau of National Health Insurance, 2002, August). However, adherence to glycemic control and self-care regimens has not been effective because the NHMP was primarily focused on health care providers, rather than family members (Tang et al., 2005). In addition, health care expenditure on diabetes has not been satisfactorily reduced. In fact, the medical costs of diabetes increased slightly from NT$140 billion ($4.29 billion US) in 2006 to NT$144 billion ($4.41 billion US) in 2007 (Department of Health, 2009a). This suggests that involving family members in the NHMP may also be needed to improve care outcomes and to reduce future medical costs in Taiwan. Nevertheless, living with diabetes can be an enormous challenge for patients and their families. Previous research has indicated that family is the primary social context that may affect how well patients manage their chronic diseases such as T2DM (Chesla et al., 2009). However,

family intervention may have both significant supportive and negative effects on care outcomes and self-care behaviours. For example, Trief et al. (1998) indicated that when family members support the diabetes care regimen (measured by DFBC), adults with diabetes were more satisfied with their adaptations to the illness. Additionally, Epple et al. (2003) conducted a survey study in the Navajo T2DM population and found that active support such as meal preparation by family members is significantly associated with better control of A1C (previously known as HbA1c), triglyceride (TG), and cholesterol levels. In contrast, Cole and Chesla (2006) found that unresolved family conflicts regarding diabetes may impede the abilities of Chinese Americans with T2DM to maintain their daily self-care behaviours and to have adequate diabetes control. In addition, Jones et al. (2008) found that African-Americans with T2DM feel themselves to be a burden and have difficulty maintaining appropriate glucose levels when family members do not fully understand diabetes. With these inconsistent findings, it is clear that research needs to further understand the effects of family intervention on glycemic control and behavioural adaptations in patients with T2DM to support future clinical intervention developments. Although there is evidence that family support plays an important role in T2DM self-management practices, it encompasses multiple dimensions that may impede the roles and functions of the family and affect patients’ management behaviours over time (Chesla et al., 2003; Van Dam et al., 2005). Norris et al. (2001) reviewed 72 randomized controlled trials and found that educational interventions that involved patient collaboration had positive effects on glycemic control and lipid profiles in the short-term. Additionally, Nelson et al. (2007) surveyed 1286 patients with T2DM who had A1C levels above 8%, and found that individuals with a higher self-efficacy score were more likely to adhere to their medication, to follow a diabetic meal plan, and to eat a lower fat diet. Tan and Magarey (2008) also surveyed 126 Malaysian adults with diabetes and found that patients with sub-optimal glycemic control as measured by fasting blood glucose levels above 7 mmol/L in the previous year still had inadequate knowledge about diabetes and poor self-care practices. Furthermore, Chen and Wang (2009) reported that the values of low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in middle-aged and elderly patients with T2DM did not significantly improve up to 9 months after enrollment in the diabetes shared care network in Taiwan. However, most of these aforementioned studies used a questionnaire-based survey design. Furthermore, these studies have mainly focused on the outcomes of patient education or the relationship between interventions and biological outcomes in patients with T2DM. Additionally, these studies did not specifically examine patients with poor glycemic control and who are most at risk for

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developing complications. Therefore, this study compares family partnership intervention care (FPIC) with conventional care (CC) in patients with poorly controlled T2DM across a number of outcome measures: (1) hemoglobin A1C, (2) body mass index (BMI), (3) plasma lipid profiles, (4) family supportive behaviours, (5) knowledge of and attitudes toward diabetes, and (6) diabetes self-care behaviours. 2. Method 2.1. Research design and participants The design was a randomized controlled trial to test the effectiveness of FPIC in adult patients with poorly controlled

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T2DM. Study participants were recruited from the diabetes outpatient clinics of a community teaching hospital in Taipei, as routine clinical data (e.g. A1C test results) are available and collected according to the American Diabetes Association (ADA) guidelines (2008). Usually, patients with T2DM were scheduled for outpatient visits each month according to the National Health Insurance guidelines in Taiwan. Recruitment and data collection took place during the 17 months from January 2006 to May 2007. Eligibility criteria required that patients: (1) were 20 years or older and thus classified as adults in Taiwan, (2) had been diagnosed as T2DM (ICD-9-CM codes of 250.0– 250.93) within the past 10 years, (3) had at least two out of their last three A1C readings equal to or greater than 7% in the previous 12 months, (4) used oral antidiabetic agents

Fig. 1. Flowchart of recruitment of participants.

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only, and (5) could read and speak Chinese. Patients were excluded if they did not live in the Taipei area, and if they had a life-threatening illness or other severe disease such as cancer, renal failure, stroke, open tuberculosis, or AIDS. This study focuses exclusively on adult patients with T2DM who are currently treated with oral medications because of the relatively low prevalence of adults with type 1 diabetes (0.54%) (Department of Health, 2009b) and because less than 10% of primary care patients with T2DM were receiving insulin therapy in Taiwan (Bureau of National Health Insurance, 2008). During the initial screening, all eligible patients received information about the purpose of the study and were invited to participate. Patients indicating an interest in participation were asked to provide written informed consent to the researchers. After receiving a consent form, each patient was assigned an Arabic numeral. Randomization using random number tables (Dixon and Massey, 1957) was computed by a third party to assign patients to the FPIC or CC group. To control for other confounding factors that might affect the validity of the study findings, patient demographics were pre-tested; no significant demographic differences between groups were found (p > 0.05). A flowchart of the recruitment processes for the study is shown in Fig. 1. To calculate the desired sample size for this study, the average effect size for A1C values of 0.87 (Gallegos et al., 2006) was used as a reference in the power analysis. Gpower 2.0 analysis software established that a sample size of 58 patients would be appropriate, given the power as 0.9 and type I error as 0.05, respectively. Based on these numbers, it was determined that a sample of 64 for two groups was required, allowing for 10% attrition. 2.2. Family partnership intervention care Family partnership intervention care (FPIC) was defined as an intervention emphasizing family participation and

support, with a goal of assisting patients with poorly controlled T2DM to gain the knowledge and skills necessary to enhance self-care behaviours and improve glycemic control. This intervention was only administered to the FPIC group and consisted of three brief individual educational sessions (IES), 2-day long group educational sessions (GES), a monthly 25–30 min telephone discussion, including an opportunity for a question/answer session. All patients and family members also received diabetes handouts about diet, medication, physical activity and exercise, and eye and foot self-care at the first IES. Each education session lasted 20–40 min and sessions were spread over 6 months. Each patient/family member dyad also received an education plan based upon their specific needs as determined from their baseline assessments. Primary family members were nominated by the patients and co-habited with them prior to intervention. Primary family members could be a spouse, parent, significant other, or additional important relative. The time schedule, duration, themes, care providers, and teaching aids of the IES and GES are summarized in Table 1. An IES was carried out at 1, 3, and 5 months during the study period at the outpatient clinic of the study hospital. A GES was held at 2 and 4 months during the study period in a mini-conference room of the study hospital. The whole contents of FPIC were delivered over a 6-month period by a certified nurse (No. 000839) of the Taiwanese Association of Diabetes Educators as well as other health professionals, such as physicians, dietitians, pharmacists, physiotherapists, foot therapists, and social workers. The methods used for the educational sessions included PowerPoint presentations and discussions. Handouts, videos, DVD’s, and other teaching aids were also used, such as food models, exchange tables, and oral medication illustrations. Finally, the IES and GES were assessed by five experts to adjust suitability and accuracy of the sessions before the intervention began. In addition, family members were

Table 1 The family partnership intervention care: the individual and group educational sessions. Time schedule

Duration (min)

Themes

Providers

Teaching aids

IES 1st month 3rd month

30 20

Diabetes and family mechanisms Eating habits

Nurses Dieticians

20

Physical activity and exercise

Nurses

Family-life assessment checklist Diabetes handouts, food models and exchange tables, cooking books Diabetes handouts

20 20

Awareness for my blood sugar levels Take care of my feet

Nurses Nurses

Diabetes handouts Diabetes handouts

20 40 20

Physicians Dieticians Dieticians

Videos and DVD Food models and exchange tables, videos Food models and exchange tables, videos

40 40

What is diabetes and medication control The nutritionist and diabetic diet control Diabetes cooking strategies and cooking demonstrations Diabetes and exercise Diabetes and foot care

Physiotherapists Nurses

Exercise DVD and videos Handouts and Powerpoints

20 40 40 40 20 20

Diabetes control and complications Diabetes and antidiabetes agents Physical therapists and exercise The foot therapist and foot care Holistic diabetes care and resources Diabetes sharing groups

Physicians Pharmacists Physiotherapists Foot therapists Social workers Nurses

Handouts and Powerpoints Oral medication pictures and Powerpoints Videos and DVD Foot massage pictures Videos Videos

5th month

GES 2nd month

4th month

Notes: IES, individual educational sessions; GES, group educational sessions.

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required to have 100% attendance to the education sessions, otherwise patients’ data were removed from the final analysis. Monthly follow-up and question/answer sessions were held through telephone interviews at the home care call center of the study hospital and conducted by the same nurses responsible for the education sessions. During the telephone interview, the patient and family member could ask any questions necessary. 2.3. Conventional care Patients in the conventional care (CC) group, without their family members, received regular care and monitored their glucose control during outpatient visits at the study hospital. Diabetes handouts and information related to illness were provided during the 6-month follow-up period. Patients were free to ask questions of the research team or their nurses and physicians at any time. 2.4. Biological outcomes The primary biological measures recorded were: (1) hemoglobin A1C, (2) body mass index (BMI), and (3) plasma lipid profiles, based on recommendations by the American Diabetes Association (2008, p. S 17) and the Taiwan Bureau of Health Promotion (2006) for T2DM evaluation in adults. To show good metabolic control for those measures, patient scores should be within acceptable ranges, as follows: A1C, 4–6%; BMI (weight in kg divided by height in m2), 18–24 kg/m2; fasting serum glucose (FSG), 80–120 mg/dl; total cholesterol (TC), 130– 220 mg/dl; triglycerides (TG), 50–130 mg/dl; LDL-C, <100 mg/dl; and HDL-C, 340 mg/dl (men) or 350 mg/dl (women). BMI was calculated by measuring weight and height without shoes, with light clothing, and an empty bladder. Hemoglobin A1C levels (Glyc-Affin Ghb, Bio-Rad D-10, USA) and FSG (glucose oxidase, Olympus AU640, Japan) were measured by a single laboratory at the study hospital. Lipid profiles were evaluated by serum plasma levels (in mg/dl) of TC (enzymatic method), TG (enzymatic hydrolysis and glycerol measurement), HDL-C (enzymatic method after very low-density lipoprotein and LDL precipitation) and LDL-C (mg/dl) (Olympus AU640, Japan) in the same laboratory at the study hospital. Every 2 years, the laboratory is certified by the College of American Pathologists. 2.5. Other study outcomes Three instruments, the diabetes family behaviour checklist (DFBC), knowledge and attitude toward diabetes questionnaire (KAQ), and diabetes self-care scale (DSC) were used for data collection. The survey also included information on demographics, including age, gender, years of duration of illness, level of education, marital status, living status, family history of DM, smoking and drinking history (Yes/No), comorbidities such as hypertension and hyperlipidemia, oral antidiabetic agents, other medications, and exercise habits (Yes/No). Oral antidiabetic agents were categorized in five groups: sulfonylurea,

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meglitinides, biguanides, a-glucosidase inhibitors, and thiazolidinediones (Maschak-Carey, 2004, p. 1170). The Chinese versions of the DFBC, KAQ, and DSC were piloted for face validity with a panel of five experts in nursing and medicine and also with 11 patients with T2DM before study began as a reliability test. Cronbach’s coefficient a was used to calculate scale reliability. However, those 11 patients’ data was not included in the final analysis. 2.5.1. The diabetes family behaviour checklist Schafer et al. (1986) developed the diabetes family behaviour checklist (DFBC) to assess the frequency of supportive and non-supportive family behaviours specific to the diabetes self-care regimen for adults and adolescents with type 1 diabetes. The DFBC measures enacted support for diabetes management related to meals, glucose monitoring, insulin administration, and exercise. The DFBC consists of 16 questions with 9 positive (supportive) and 7 negative (non-supportive) items and, for each item, ratings from never (1), twice a month (2), once a week (3), several times a week (4), and at least once a day (5). A positive summary score ranges from 9 to 45 points, and a negative summary score ranges from 7 to 35 points. The higher the scores on positive items, the more supportive family behaviour; the higher the scores on negative items, the more non-supportive family behaviour. Schafer et al. (1986) reported having a good face validity and sufficient reliability of the DFBC (Cronbach’s a = 0.73 for the positive scores and 0.43 for the negative scores). The DFBC was previously translated to Chinese by Chang et al. (1991); unfortunately, the results of psychometric properties were not reported. For this present study, three questions, 3, 14, and 15, asking about insulin use were rewritten to address the oral antidiabetic agents used. The coefficient a value for the total scale, the subscale of positive items, and the subscale of negative items indicated that these were reliable (a = 0.91, 0.94, and 0.76, respectively). 2.5.2. The knowledge and attitude toward the diabetes questionnaire The knowledge and attitude toward the diabetes questionnaire (KAQ) was developed by Huang et al. (1998) to measure patients’ knowledge of and attitudes toward diabetes. The knowledge portion of the KAQ was a self-administrated questionnaire and included 20 items focusing on diabetic symptoms, medication, diet, glucose testing, exercise, and foot care. Each item was rated as true or false, and one point was assigned for each correct answer. Scores ranged from 0 to 20 points, with higher scores indicating better knowledge of diabetes. The attitude portion of the KAQ was also a self-administrated questionnaire and included 20 items on a 4-point Likerttype scale from 1 (totally disagree) to 4 (totally agree). The questionnaire included questions about attitudes toward glucose control methods, complication management, daily foot care, and emotional and stress management. Scores ranged from 20 to 80 points, with higher scores indicating a more positive attitude toward diabetes. The KAQ was previously tested by its original authors in a Taiwanese population with T2DM and demonstrated the good

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reliability (a = 0.75). The values of item difficulty were between 0.2 and 0.8, and item discrimination was greater than 0.2 (Huang et al., 1998). In this present study, the knowledge and the attitude portions of the KAQ for the total scale were reliable (a = 0.71 and 0.75, respectively). 2.5.3. The diabetes self-care scale The diabetes self-care scale (DSC) was developed by Hurley and Shear (1992) and previously translated to Chinese by Wang et al. (1998). The Chinese version of the DSC contained 27 items used to measure self-reported behaviours such as adherence to monitoring, planning, and carrying out activities of daily living such as exercise, diet, medication, glycemic control monitoring, foot care, and prevention and management of hyperglycemia and hypoglycemia. Patients were asked to indicate their levels of adherence or performance on a rating scale ranging from 1 to 5: never, seldom, sometimes, always, and completely done. Scores ranged from 27 to 135 points; the higher scores indicated better adherence of diabetes self-care behaviours. The psychometric properties of the Chinese version of the DSC were tested and showed that a coefficients were quite acceptable (6 general items, a = 0.80; 7 diet items, a = 0.81; 9 oral antidiabetic agent items, a = 0.79) (Wang et al., 1998). In this present study, the coefficient a value was 0.90, indicating that the Chinese version of the DSC shows high internal consistency. 2.6. Ethical considerations Before contacting potential patients, the Institutional Review Board at the study organization approved this study (MR-9412). Those who met the criteria for inclusion received a formal letter containing information on the study’s purposes, procedures, and data management. The patients were also informed about their right to withdraw from the study at any time during the study period. Written consent was obtained from each participant. All information was confidential and only seen by the researchers. After completing the study, patients received a small gift as a reward. 2.7. Data collection, management, and analysis All questionnaires, biological and other study outcomes were administered and collected by a trained research assistant at baseline before commencement of the study and 6 months post-intervention at the outpatient clinics of the study hospital. The biological outcomes were abstracted from patients’ medical charts closest to the time of data collection. The research assistant was not aware of the group allocation of patients in the study. All completed questionnaires and data were then returned to the primary investigator’s office for data entry and analyses. Descriptive analyses, including percentage, number of cases, mean, and standard deviation, were used to present characteristics of the study patients. The differences between groups in biological outcomes and scores of family support, knowledge and attitude toward diabetes,

and diabetes self-care were calculated as the mean values at 6 months post-intervention minus the mean values of baseline. Normal probability plots for the study variables demonstrated that the data were not normally distributed, indicating that non-parametric statistical techniques of data analysis were appropriate. Therefore, the Wilcoxon Mann–Whitney U tests and Fisher’s exact tests were performed to compare differences in outcomes between groups. Analysis of all the data in this study was undertaken using the Statistical Package for the Social Sciences/PC+ (SPSS for Windows 15.0, Chicago, IL) with the level of significance for all statistical analyses being set at p < 0.05. 3. Results 3.1. Participant characteristics Fig. 1 illustrates the recruitment and selection of patients in the study. Of the initial 1115 patients screened, only 358 patients had data indicating A1C levels greater than 7% in the past year. Of these, 109 patients with poorly controlled T2DM met the criteria for inclusion and 67 agreed to participate. During the study period, 11 patients (5 in the FPIC and 6 in the CC group) were dropped either because of lost to follow-up (n = 5), more than 80% of data were missing (n = 3), or they did not attend all education sessions (n = 3). However, there was no significant difference in demographics between these non-participants and the 56 patients who remained in the study, whether they were FPIC patients, or CC patients (p > 0.05). Therefore, the reported results pertain to the final sample of 56 patients, of which 28 were in the FPIC group and 28 in the CC group. Overall, the average age was 54.5 years. The mean duration of diabetes was 3.4 years. Most patients were males (n = 30; 53.6%), married (n = 51; 91.1%), had high school qualifications (n = 32; 57.1%), had DM family history (n = 38; 67.9%), had comorbidity such as hypertension and hyperlipidemia (n = 42; 75%), did not smoke (n = 44; 75%) or use alcohol (n = 40; 71.4%), and lived with their family members (n = 55; 98.2%). For the 28 family members in the FPIC group, most were women (n = 20; 71.4%) as well as 8 husbands, 14 wives, 4 daughters, 1 mother, and 1 daughter-in-law. Table 2 shows that significant demographic differences were not found between the two groups (p > 0.05). However, patients in the FPIC group were older on average, had fewer years of diabetes, had a higher percentage of men, were better educated, were married, had no DM family history, no smoking and drinking history, and were more likely to take biguanide medications. All patients lived with their family members. 3.2. The results of biological outcomes 3.2.1. Hemoglobin A1C levels Table 3 shows that the mean A1C level for the two groups was similar at the baseline (9.25% vs. 9.05%) and at 6 months post-intervention (7.9% vs. 8.12%). Overall, the mean A1C value decreased in FPIC patients more than CC patients (mean difference 1.35% vs. 0.93%) (abbrevia-

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Table 2 Characteristics of patients (N = 56). Variables

FPIC (n = 28) n (%)

Age (years) Duration of diabetes (years)

CC (n = 28) M  SD

n (%)

55.3  7.7 3.8  3.2

p M  SD 51.7  8.5 4.4  3.0

0.13a 0.24a 0.79b

Gender Male Female

16(57.1) 12(42.8)

14 (50.0) 14 (50.0)

Education level Junior high school High school

11(39.3) 17(60.7)

13(46.5) 15(53.5)

Martial status Single Married

1(3.6) 27(96.4)

4 (14.3) 24 (85.7)

Family history Yes No

17(60.7) 11(39.2)

21(75.0) 7(25.0)

Live alone Yes No

0(0.0) 28(100)

1 (3.6) 27 (96.4)

Smoking history Yes No

6(21.4) 22(78.6)

8(28.6) 20(71.4)

Drinking history Yes No

7(25.0) 21(75.0)

9 (32.1) 19 (67.9)

15(53.6) 9(32.1) 2(7.1)

11 (39.3) 14 (50.0) 2 (7.1)

0.42b 0.28b 1.00b

Oral antidiabetic agents Sulfonylurea Meglitinides Biguanides a-Glucosidase inhibitors Thiazolidinediones

18(64.3) 4(14.3) 22(78.6) 11(39.3) 9 (32.1)

19 5 20 12 8

(67.9) (17.9) (71.4) (42.9) (28.6)

1.00b 1.00b 1.00b 1.00b 1.00b

Other medications ACE inhibitors Angiotension II antagonists Thiazide diuretics Fibrates Statins

3 3 12 4 6

2 2 9 5 9

(7.1) (7.1) (32.1) (17.9) (32.1)

1.00b 1.00b 0.58b 1.00b 0.54b

Exercise habit Yes No

16 (57.1) 12 (42.9)

Comorbidity Hypertension Hyperlipidemia Others (cardiovascular disease and cerebralvascular disease)

0.79b

0.26b

0.25b

1.00b

0.76b

0.77b

(10.7) (10.7) (42.9) (14.3) (21.4)

18 (64.3) 10 (35.7)

0.79b 0.79b

Notes: FPIC, family partnership intervention care; CC, conventional care. a Wilcoxon Mann–Whitney U test. b Fisher’s exact test.

tion D). However, this change was not significant (p = 0.46). The result indicated that patients in this study had poor glycemic control (A1C > 7%). However, a higher proportion of patients (n = 8; 28.6%) in the FPIC group reached A1C values below 7% than patients in the CC group (n = 3; 10.7%). 3.2.2. Body mass index Table 3 shows that all patients’ mean BMI were greater than 26 kg/m2 at baseline and at 6 months post-intervention indicating that the patients in this study were

overweight. Although a small reduction in BMI was achieved for both groups, the differences were not significant (p = 0.35). 3.2.3. Plasma lipid profiles Table 3 shows that the FPIC group experienced more reduction in FSG (D = 32.29 vs. 10.85) and TG (D = 53.75 vs. 43.39), but experienced less improvement in TC (D = 12.82 vs. 11.17), LDL-C (D = 2.33 vs. 2.21), and HDL-C (D = 0.79 vs. 3.46) compared to the CC group. However, there were no statistically significant

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Table 3 Comparison of biological outcomes between the groups (N = 56). Variables

Hemoglobin A1C (<7%) BMI (18–24 kg/m2) FSG (80–120 mg/dl) TC (130–220 mg/dl) TG (50–130 mg/dl) LDL-C (<100 mg/dl) HDL-C Men 3 40 mg/dl Women 3 50 mg/dl

FPIC (n = 28)

CC (n = 28)

Mann– Whitney

Baseline

At 6-month post-intervention

Mean

Baseline

At 6-month post-intervention

Mean

M (SD)

M (SD)

Difference

M (SD)

M (SD)

Difference

9.25(1.99) 26.79(2.76) 178.50(60.30) 209.50(42.07) 206.79(117.33) 127.25(37.79)

7.9(1.36) 26.66(2.56) 146.21(32.73) 196.68(32.56) 153.04(62.35) 124.92(29.67)

9.05(1.84) 26.55(3.50) 167.71(54.57) 203.46(50.47) 203.54(147.41) 126.46(31.58)

8.12(1.21) 26.31(3.15) 156.86(46.44) 192.29(35.18) 160.14(89.12) 124.25(30.81)

.93 .24 10.85 11.17 43.39 2.21

.74 .94 1.39 .64 1.03 .17

0.46 0.35 0.16 0.52 0.30 0.86

46.96(10.76) 43.06(9.73) 38.50(5.56)

47.75(8.87) 45.56(9.34) 41.00(5.76)

41.86(8.59) 52.17(10.16) 45.21(9.91)

45.32(9.66) 50.67(7.61) 49.64(10.97)

3.46 1.50 4.43

1.25 .27 1.63

0.21 0.79 0.10

1.35 .13 32.29 12.82 53.75 2.33 .79 2.5 2.5

z

p

Notes: FPIC, family partnership intervention care; CC, conventional care. BMI: body mass index; FSG: fasting serum glucose; TC: total cholesterol; TG: triglyceride; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol.

3.3. Differences in family supportive behaviours, knowledge and attitudes toward diabetes, and diabetes self-care behaviours between the groups

(from 3.68 to 3.93; D = 0.25) were found as the 2 lowest rated items. However, the overall family support was not significantly associated with lower A1C because there was no significant difference between those who had A1C > 7% and <7% in the FPIC group (p = 0.601 for positive supportive behaviour).

3.3.1. Family supportive behaviours Table 4 shows that, after 6 months, the FPIC patients perceived more positive family support compared to CC patients (D = 3.57 vs. 0.0, respectively; p = 0.000). Also the FPIC patients perceived less negative family support compared to CC patients (D = 3.29 vs. 1.64, respectively; p = 0.031). We further analyzed individual items of the DFBC for the FPIC patients. Patients reported ‘‘Praise you for following your diet’’ (from 3.46 to 4.29; D = 0.83) and ‘‘Encourage you to participate in sports activities’’ (from 2.18 to 3.0; D = 0.82) as the most supportive behaviours shown by family members. In contrast, both ‘‘Plan family activities so that they will fit in with your diabetes self-care schedule’’ (from 3.89 to 3.96; D = 0.07) and ‘‘Help you decide if changes should be made based on glucose testing’’

3.3.2. Knowledge and attitudes toward diabetes As shown in Table 4, the mean difference scores of knowledge of diabetes increased for patients in the FPIC group significantly more than those of the CC group (D = 5.32 vs. 2.32, respectively; p = 0.005). Additionally, the mean difference score of the attitudes toward diabetes increased more for patients in the FPIC group than the CC group (D = 2.72 vs. 0.14, respectively; p = 0.030). These results indicate that patients in the FPIC group had greater improvement in their knowledge, but less improvement in their attitudes toward diabetes (from disagree to agree to each statement) than did patients in the CC group after 6 months post-intervention. Upon analysis of each item, we found that the top 2 improvement items related to knowledge of diabetes in the FPIC group were ‘‘If there is no sugar in the urine, it means

differences between the groups for any of these parameters (p > 0.05).

Table 4 Comparison of the scores of family supportive behaviours, knowledge and attitudes toward diabetes, and diabetes self-care behaviours between the groups (N = 56). Variables

Positive family supportive behaviour (total = 45 points) Negative family supportive behaviour (total = 35 points) Knowledge related to diabetes (total = 20 points) Attitudes toward to diabetes (total = 76 points) Diabetes self-care behaviours (total = 135 points)

FPIC (n = 28)

CC (n = 28)

Baseline

At 6-month post-intervention

Mean

M (SD)

M (SD)

Difference

Baseline

Mann–Whitney At 6-month post-intervention

Mean Difference

z

p

M (SD)

M (SD)

31.32(5.56)

34.89(4.16)

3.57

28.79(6.09)

28.79(5.90)

.00

3.67

0.000*

20.00(3.46)

16.71(1.86)

3.29

18.68(4.11)

17.04(3.07)

1.64

2.16

0.031*

10.86(3.46)

16.18(2.02)

5.32

12.32(3.60)

14.64(2.44)

2.32

2.83

0.005*

56.39(4.83)

59.11(5.20)

2.72

56.43(4.76)

56.57(7.69)

.14

2.17

0.030*

87.64(14.07)

96.68(16.32)

88.14(15.38)

101.89(12.97)

13.75

Notes: FPIC, family partnership intervention care; CC, conventional care. * p < 0.05.

9.04

.517

0.605

C.-M. Kang et al. / International Journal of Nursing Studies 47 (2010) 1363–1373

diabetes free’’ (from 0.11 to 0.68; D = 0.57) and ‘‘Patients can eat unsweetened fruits such as guava and wax apple which would help to control blood glucose’’ (from 0.39 to 0.89; D = 0.50). Conversely, the items showing no improvement were ‘‘Diabetes is a controllable disease’’ (from 0.93 to 0.93; D = 0) and ‘‘When low blood glucose occurs, I should take sweetener to raise it’’ (from 0.75 to 0.75; D = 0). For the attitude portion of the KAQ, the top 2 improvement items were ‘‘It is very helpful to discuss diabetes with health care providers’’ (from 3.25 to 3.61; D = 0.36) and ‘‘Because I feel it is difficult to calculate the food calories I just eat a little of everything’’ (from 2.36 to 2.68; D = 0.32). In contrast, the 2 lowest improvement items were ‘‘Patients with diabetes should understand how many calories they can take every day’’ (from 3.14 to 3.14; D = 0) and ‘‘When I am busy, I can take my medicine later’’ (from 3.07 to 3.14; D = 0.07). 3.3.3. Diabetes self-care behaviours Table 4 shows that patients in the FPIC group showed more improvement in diabetes self-care behaviours than did patients in the CC group at a 6-month follow-up (D = 13.75 vs. 9.04). However, there was no statistically significant difference between the groups (p = 0.605). We further analyzed each item of DSC for the FPIC patients and found that the 2 items showing greatest adherence were ‘‘I will follow the foot care method to cut my nails’’ (from 2.93 to 4; D = 1.07) and ‘‘I will record my glucose test results daily’’ (from 2.5 to 3.71; D = 1.21). In contrast, the 2 lowest adherence items were ‘‘I will take medication on time every day’’ (from 3.93 to 3.93; D = 0) and ‘‘I will use a food exchange table to select the foods that I need’’ (from 4.25 to 4.54; D = 0.29). 4. Discussion This randomized control trial study revealed that after 6 months, both groups of patients still had poor glycemic control (A1C > 7%), with a trend to improved A1C levels in the FPIC group, although this was not found to be significant. The result could be affected by the small sample size and the short follow-up period used in this study. Although we recruited 67 patients from outpatient clinics at the beginning of the study, only 56 patients remained for final analysis. Thus, the small sample size may indicate that it was not possible to have explored the differences between the groups. In addition, despite careful randomization in this study, patients in the CC group started with slightly better metabolic parameters at baseline than the FPIC group; therefore, it may possibly impede the capacity of the study to yield clear intervention effects. Furthermore, insufficient follow-up time may also have limited the ability to note the effects of family intervention on reduction in A1C values and to observe significant differences between the groups. However, Brown et al. (2002) supported the finding and indicated that, although the mean A1C value was reduced for Mexican Americans with T2DM participating in the culturally competent diabetes self-management intervention at 6 and 12 months, the level of A1C was still greater than 10%. Nevertheless, Stratton et al. (2000) indicated that

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each 1% drop in A1C level is associated with a significant reduction in the risk of diabetes-related death (21%), myocardial infarction (14%) and microvascular complications (37%). Thus, additional efforts to reduce A1C values in patients with poorly controlled T2DM are needed. Although the results of FSG, TG, TC, and LDL-C in this study did not significantly improve for patients in either group, all mean values were reduced in the FPIC group. The results demonstrate that FPIC is not as effective as we expected in improving the plasma lipid profiles in patients with poorly controlled T2DM at 6 months post-intervention. This finding is supported by Brown et al. (2005), who indicated that after a year long intervention, no group differences in FSG levels were detected. However, the finding was not supported by Tien et al. (2008), who implemented a comprehensive diabetes care program for Taiwanese T2DM patients and found that FSG, TC, LDL-C, and HDL-C had improved significantly by 1 year. The difference in these findings may be due to the short followup period in this study. Thus, a longer follow-up is suggested for future studies. We also found that patients in the FPIC group perceived more positive support from family members than those in the CC group, which resulted in better improvements in knowledge and attitudes related to T2DM, but not for the adherence to self-care practices such as medication-taking and food choices. The results are consistent with previous studies. Siminerio et al. (2005) and Van Dam et al. (2005) pointed out that greater family support improved knowledge, psychosocial functioning, and feelings of empowerment in patients with T2DM. Norris et al. (2001) conducted a systematic literature review study and also found that increased knowledge for patients with T2DM yielded no significant improvement in glycemic control and behavioural change. However, Wen et al. (2004) and Tang et al. (2008) reported different findings: with greater family support, the better adherences to diet regimens and to regular exercise. Nevertheless, a study by Jones et al. (2008) found that, although family and friends were very supportive for African-Americans with T2DM, they may also create problems that make things more challenging such as bringing home junk foods and other sweets. Furthermore, Chesla et al. (2009) found that conflicts may also arise when family members do not respect and accommodate patients’ dietary restrictions or cook unhealthy foods. The inconsistent findings may imply that knowing is not equal to doing and that factors other than family support and knowledge are needed to achieve behavioural change. Thus, we suggest that further studies on family intervention influencing selfcare behaviours should be pursued to achieve a better understanding of patient–family interaction and of how well patients adapt over time. Our study was not without limitations. First, due to the 16% attrition rate and small sample size, the statistical analysis may fail to identify actual differences between the groups. Second, since socio-economic information was not collected for patients in this study, there may be a risk of bias for the internal validity if both groups had differed in terms of these variables. Third, patients were recruited

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only from the outpatient clinics of the community teaching hospital in Taipei and therefore findings should not be generalized beyond the study samples. Fourth, although five experts evaluated the contents of the IES and GES before our study began, the delivery processes for each session were not assessed in this study. Consequently, the outcomes could be affected. Therefore, validity checks of each session during interventions are suggested for future researchers to ensure all sessions are properly delivered. Finally, the Chinese versions of the instruments used in this study were not assessed with a comprehensive psychometric property testing, such as test–retest reliability, criterion and construct validity. Therefore, these Chinese instruments should be further tested before they are used in future studies. 5. Conclusions This family context study is one of few studies conducted in Taiwan to use multiple outcome measures to assess the effectiveness of FPIC in patients with poorly controlled T2DM. Although the results of this study do not provide categorical support for improved biological outcomes and diabetes self-care behaviours in patients with poorly controlled T2DM in the FPIC group, the findings still have some important clinical implications for diabetes care. For nurses and other health care providers, the results indicate that integration of family members in care for diabetic patients may possibly support the patients’ knowledge and capabilities to cope with that chronic disease, but further well-conducted studies are necessary to evaluate the interrelation between family support, selfcare, and glycemic control in patients with diabetes at the community level. Conflicts of interest None declared. Funding None. Ethical approval The reference number was MR-9412. References American Diabetes Association, 2008. Standards of medical care in diabetes-2008. Diabetes Care 31 (S1), S12–S54. Brown, S.A., Garcia, A.A., Kouzekanani, K., Hanis, C.L., 2002. Culturally competent diabetes self-management education for Mexican Americans: the Starr County Border Health Initiative. Diabetes Care 25 (2), 259–268. Brown, S.A., Blozis, S.A., Kouzekanani, K., Garcia, A.A., Winchell, M., Hanis, C.L., 2005. Dosage effects of diabetes self-management education for Mexican Americans: the Starr County Border Health Initiative. Diabetes Care 28 (3), 527–532. Bureau of National Health Insurance, 2002. Years of 2002 to 2005 health plan. http://www.nhi.gov.tw/webdata/webdata.asp?menu=9&menu _id=364&webdata_id=2118 (retrieved 13.12.09) (original work published in Chinese). Bureau of Health Promotion, 2006. Diabetes and me. http:// www.bhp.doh.gov.tw/BHPnet/Portal/Find.aspx?Keywords:=%e7%b3%96%e5%b0%bf%e7%97%85 (retrieved 07.09.09) (original work published in Chinese). Bureau of National Health Insurance, 2008. The analysis of out-patient department medication used among patients with diabetes from 2001 to 2003. http://www.nhi.gov.tw/webdata/webdata.asp?menu=

3&menu_id=57&webdata_id=848&WD_ID= (retrieved 02.09.09) (original work published in Chinese). Chang, F.T., Chiou, C.J., Shin, S.J., Tsai, J.H., 1991. Relationship among family support and patients’ knowledge, attitude, compliance, HbA1c level in diabetes control. The Journal of Nursing Research 38 (3), 59– 69. Chen, T.W., Wang, J.Y., 2009. Effectiveness of the diabetes shared care network for middle-aged and elderly patients in a rural area of Taiwan. Taiwan Journal of Public Health 28 (4), 334–343. Chesla, C.A., Fisher, L., Skaff, M.M., Mullan, J.T., Gilliss, C.L., Kanter, R., 2003. Family predictors of disease management over one year in Latino and European American patients with Type 2 Diabetes. Family Process 42 (3), 375–390. Chesla, C.A., Chun, K.M., Kwan, C.M.L., 2009. Cultural and family challenges to managing type 2 diabetes in immigrant Chinese Americans. Diabetes Care 32 (10), 1812–1816. Cole, I., Chesla, C.A., 2006. Interventions for the family with diabetes. Nursing Clinics of North America 41, 625–639. Department of Health, 2009. Health and vital statistics: diabetes statistics. http://www.doh.gov.tw/CHT2006/DisplayStatisticFile.aspx?d= 69451&s=1 (retrieved 20.01.09). Department of Health, 2009. The statistics of number of outpatient and hospitalized patients. http://www.doh.gov.tw/CHT2006/DM/DM2_2. aspx?now_fod_list_no=10349&class_no=440&level_no=3 (retrieved 04.09.09) (original work published in Chinese). Dixon, W.J., Massey, Jr., F.J. (Eds.), 1957. Introduction to Statistical Analysis. McGraw-Hill, New York. Epple, C., Joish, V.N., Wright, A.L., Bauer, M., 2003. The role of active family nutritional support in Navajos’ T2DM metabolic control. Diabetes Care 26 (10), 2829–2834. Gallegos, E.C., Ovalle-Beru´men, F., Gomez-Meza, M.V., 2006. Metabolic control of adults with T2DM mellitus through education and counseling. Journal of Nursing Scholarship 38 (4), 344–351. Huang, C.I., Jeng, H.M., Shen, D.C., 1998. Diabetes knowledge, attitude, behavior and patient education needs in diabetic patients at outpatient department. Health Promotion & Health Education Journal 18 (12), 25–35. Hurley, C.C., Shear, C., 1992. Self-efficacy: strategy for enhancing diabetes self-care. The Diabetes Educator 18 (2), 146–150. Jones, R.A., Utz, S.W., Williams, I.C., Hinton, I., Alexander, G., Moore, C., Blanhenship, J., Steeves, R., Oliver, N., 2008. Family interactions among African Americans diagnosed with type 2 diabetes. The Diabetes Educator 34 (2), 318–326. Maschak-Carey, B.J., 2004. Assessment and management of patients with diabetes mellitus. In: Smeltzer, S.C., Bare, B. (Eds.), MedicalSurgical Nursing. Lippincott Williams & Wilkins, Philadelphia, pp. 1149–1203. Nelson, K.M., McFarland, L., Reiber, G., 2007. Factors influencing disease self-management among veterans with diabetes and poor glycemic control. Society of General Internal Medicine 22 (4), 442–447. Norris, S.L., Engelgau, M.M., Narayan, K.M., 2001. Effectiveness of selfmanagement training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care 24 (3), 561–587. Schafer, L.C., Kevin, M.S., Mccaul, D., Glasgow, R.E., 1986. Supportive and non-supportive family behaviors: relationships to adherence metabolic control in persons with type I diabetes. Diabetes Care 9 (2), 179– 185. Siminerio, L.M., Piatt, G., Zgibor, J.C., 2005. Implementing the chronic care model for improvements in diabetes care and education in a rural primary care practice. The Diabetes Educator 31 (2), 225– 234. Stratton, I.M., Adler, A.I., Neil, H.A., Manley, S.E., Cull, C.A., Hadden, D., Turner, R.C., Holman, R.R., 2000. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 321 (7258), 405– 412. Tan, M.Y., Magarey, J., 2008. Self-care practices of Malaysian adults with diabetes and sub-optimal glycaemic control. Patient Education and Counseling 72, 252–267. Tang, P.L., Yuan, W.L., Tseng, H.F., 2005. Clinical follow-up study on diabetes patients participating in a health management plan. Journal of Nursing Research 13 (4), 253–262. Tang, T.S., Brown, M.B., Funnell, M.M., Anderson, R.M., 2008. Social support, quality of life, and self-care behaviors among African Americans with type 2 diabetes. Diabetes Education 34 (2), 266–276. Tien, K.J., Hung, H.C., Hsiao, J.Y., Hsu, S.C., Hsin, S.C., Shin, S.J., Hsieh, M.C., 2008. Effectiveness of comprehensive diabetes care program in Taiwanese with T2DM. Diabetes Research and Clinical Practice 79 (2), 276–283.

C.-M. Kang et al. / International Journal of Nursing Studies 47 (2010) 1363–1373 Trief, P.M., Grant, W., Elbert, K., Weinstock, R.S., 1998. Family environment, glycemic control, and psychosocial adaptation of adults with diabetes. Diabetes Care 21 (2), 241–245. Van Dam, H.A., van der Horst, F.G., Knoops, L., Ryckman, R.M., Crebolder, H.F.J.M., van den Borne, B.H.W., 2005. Social support in diabetes: a systematic review of controlled intervention studies. Patient Education and Counseling 59, 1–12.

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Wang, J.S., Wang, R.H., Lin, C.C., 1998. Self-care behaviors and related factors in outpatients newly diagnosed with non-insulin-dependent diabetes mellitus. The Journal of Nursing 45 (2), 60–73. Wen, L.K., Parchman, M.L., Shepherd, M.D., 2004. Family support and diet barriers among older Hispanic adults with T2DM. Family Medicine 36 (6), 423–430.