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Individual therapeutic-cognitive intervention of the psychological and behavioural symptoms of patients with dementia (PRESTA study)
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Rev Cient Soc Esp Enferm Neurol. 2019;xxx(xx):xxx---xxx
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ORIGINAL ARTICLE
Individual therapeutic-cognitive intervention of the psychological and behavioural symptoms of patients with dementia (PRESTA study)夽 Sílvia Reverté-Villarroya a,b,∗ , Josep Zaragoza-Brunet b , Calamanda Matamoros-Obiol b , Ester Inglada-García b , Sonia Escalante-Arroyo b , Eva Forcadell-Ferreres b , Patricia Esteve-Belloch b a
Facultad de Enfermería, Departamento de Enfermería, Universitat Rovira i Virgili (URV), Tortosa, Tarragona, Spain Servicio de Neurología, Hospital de Tortosa Verge de la Cinta, Instituto de Investigación Sanitaria Pere i Virgili (IISPV), Tortosa, Tarragona, Spain
b
Received 14 February 2019; accepted 20 August 2019
KEYWORDS Dementia; Behavioral symptoms; Caregivers; Educational assessment; Nursing care
Abstract Introduction: The behavioral and psychological symptoms of dementia (BPSD) frequently appear associated with patients with dementia, aggravating their cognitive and behavioral status, which generates anguish for their main caregivers. Non-pharmacological therapies are a method to approach BPSD. Aim: To analyze the effectiveness of a behavioral educational intervention and support to the family caregiver on the reduction of its overload, and if this reduction has a positive impact on BPSD of the patient with dementia. Methods: A randomized, controlled, double-blind trial was conducted with patients with dementia and their principal caregivers (PC). The PC were randomized to the intervention group (IG) or control (CG). The intervention consisted an individual cognitive-behavioral education performed by outpatient nursing, with periodic telephone contacts, during 3 months. CG received treatment as usual. Cognitive function was assessed using the cognitive scale MiniMental State Exploration (MMSE), Neuropsychiatric inventory (NPI-10) and depressive Geriatric Depression Scale (GDS). And caregiver reported burden through (Zarit Caregiver Burden Inventory). The Quantitative and qualitative data of SPCD’s were collected at baseline and after the intervention. Results: The mean total age of patients was 78.96 (± 6.64) years and 50% were men. And in PC (n = 28) of 58.64 (± 11.69) years, and 92.9% were women. The IG (n = 13) showed better
PII of original article: S2013-5246(19)30015-7 夽 Please cite this article as: Reverté-Villarroya S, Zaragoza-Brunet J, Matamoros-Obiol C, Inglada-García E, Escalante-Arroyo S, ForcadellFerreres E, et al. Intervención terapéutico-cognitiva individual de los síntomas psicológicos y conductuales de pacientes con demencia (estudio PRESTA). Rev Cient Soc Esp Enferm Neurol. 2019. https://doi.org/10.1016/j.sedene.2019.08.001 ∗ Corresponding author. E-mail address: [email protected] (S. Reverté-Villarroya). 2530-299X/© 2019 Sociedad Espa˜ nola de Enfermer´ıa Neurol´ ogica. Published by Elsevier Espa˜ na, S.L.U. All rights reserved.
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S. Reverté-Villarroya et al. score than the CG (n = 15) in the MMSE p < 0,001 and the GDS p < 0,001, although without changes in the NPI-10 (p = 0,419), between the start visit and at 3 months, indicating improvement cognitive and depressive after the intervention. The PC also obtained statistically significant scores in the Zarit (p = 0,010). SPCD’s improved significantly in GI: repetition p < 0,001, depression (p = 0,013), apathy and indifference (p = 0,003), sleep and diurnal rhythm disorders (p = 0,006) and eating disorders (p = 0,019) at 3 months. Clinicaltrials.gov Identifier: NCT03732521. Conclusions: The non-pharmacological therapy of individual therapeutic-cognitive intervention directed to caregivers and carried out by nursing personnel expert in its management, has a favorable impact in the control and reduction of the SPCD of patients with dementia. © 2019 Sociedad Espa˜ nola de Enfermer´ıa Neurol´ ogica. Published by Elsevier Espa˜ na, S.L.U. All rights reserved.
PALABRAS CLAVE Demencia; Síntomas psicológicos y conductuales; Cuidadores; Intervención educativa; Cuidados de enfermería
Intervención terapéutico-cognitiva individual de los síntomas psicológicos y conductuales de pacientes con demencia (estudio PRESTA) Resumen Introducción: Los síntomas psicológicos y conductuales de las demencias (SPCD) aparecen con frecuencia asociados a los pacientes con demencia, agravando su estado cognitivo y conductual, que genera angustia a sus cuidadores principales. Las terapias no farmacológicas, son un método para abordar los SPCD. Objetivo: Analizar la eficacia de una intervención terapéutica-conductual y de apoyo al cuidador familiar sobre la reducción de su sobrecarga, y si dicha reducción tiene un impacto positivo sobre los SPCD del paciente con demencia. Método: Ensayo clínico, randomizado, doble ciego e una muestra de pacientes con demencia y sus cuidadores principales (CP). Los CP fueron asignados a un grupo de intervención (GI) y control (GC). La intervención consistió en una educación cognitiva-conductual individual realizada por enfermería ambulatoria, con controles periódicos telefónicos durante 3 meses. El GC recibió la atención de práctica clínica habitual. Fue evaluada la función cognitiva: escala Mini-Mental (MMSE), y Neuropsychiatric inventory (NPI-10), la depresiva: escala depresión Geriátrica (GDS) y sobrecarga del cuidador: escala Zarit. Los SPCD fueron recogidos según datos cuantitativos y cualitativos en la visita inicial y final. Resultados: Edad media total de pacientes 78,96 (±6,64) a˜ nos y distribución por sexos (50%) hombres. Los CP (n = 28), mostró una edad media de 58,64 (±11,69) a˜ nos, siendo la práctica totalidad (92.9%) mujeres. El GI (n = 13) mostró mejor puntuación que el GC (n = 15) entre visitas (inicial y 3 meses), tanto en el MMSE p < 0,001 como en la GDS p < 0,001, aunque sin cambios en la NPI-10 (p = 0,419), indicando mejoría cognitiva y depresiva tras la intervención. Los cuidadores también obtuvieron puntuaciones estadísticamente significativas en el Zarit (p = 0,010). Los SPCD mejoraron en el GI: repetición p < 0,001, depresión (p = 0,013), apatía e indiferencia (p = 0,003), trastornos del sue˜ no y del ritmo diurno (p = 0,006) y trastornos de la alimentación (p = 0,019) a los 3 meses. Identificador Clinicaltrial.gov: NCT03732521. Conclusiones: La terapia no farmacológica de intervención terapéutica-cognitiva individual dirigida a cuidadores y conducida por personal de enfermería experto en su manejo, tiene un impacto favorable en el control y reducción de los SPCD de los pacientes con demencia. © 2019 Sociedad Espa˜ nola de Enfermer´ıa Neurol´ ogica. Publicado por Elsevier Espa˜ na, S.L.U. Todos los derechos reservados.
Introduction Dementia is a neuropsychiatric syndrome with a peak incidence from the age of 65.1 In 2015, an estimated 47 million people worldwide had dementia, and if its prevalence persists, this will be 130 million by 2050, all influenced by the increase in longevity and survival in the population.2
One of the main characteristics of dementia is cognitive deterioration with progressive impairment in daily functions often associated with behavioural alterations. Hence the onset of the behavioural and psychological symptoms of dementia (BPSD), defined as ‘‘disturbed perception, thought content, mood, and behaviour’’.3 These disturbances, such as agitation, depression, euphoria, delirium and hallucinations, are related to each other. Approximately 5 out of 6
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Short title: Individual therapeutic-cognitive intervention of the psychological symptoms patients with dementia will develop BPSD.4,5 Twenty percent of people will start with BPSD in the first 2 years after a diagnosis of dementia and at least 50% will develop new BPSD every month.6 BPSD such as agitation can present for several months in 50%---80% of cases. These symptoms are the manifestations that cause patients, their caregivers and society in general the most distress.7 Moreover, the 2 symptomatic spheres (cognitive and functional) worsen, which entails a higher economic cost, stress to caregivers, functional disability and decreased quality of life (of caregivers and patients), all of which precipitates the early institutionalisation of patients with dementia.8,9 In general, the therapeutic approach to BPSD should be multidisciplinary and coordinated at different levels of care, combining both pharmacological and non-pharmacological interventions (NPIs).10,11 NPIs in dementia are part of the biopsychosocial model of patient care.12 Compared to drugs, they have a more favourable side effect profile due to the added value of social contact and possibility of greater individualisation.13---15 We found evidence in the literature on the efficacy of outpatient educational interventions in family caregivers in reducing overload and improving mood15,16 but little is known as to whether this improvement might have an indirect impact on the patient’s BPSD, or on their caregiver. Thus, the objective of this study was to analyse the efficacy of an individual behavioural educational intervention and support provided to the family caregiver in reducing their overload and whether such reduction has a positive impact on the BPSD of the patient with dementia.
Methods Design and study population A clinical, randomised, double-blind and comparative trial was conducted among a sample of patients with dementia who received isolated medical treatment compared with another group with treatment plus an educational intervention by a nurse to support the main caregiver at the Hospital de Tortosa Verge de la Cinta (HTVC), from March 2014 to November 2017. The study obtained the approval of the reference Clinical Research Ethics Committee with the code CEIC-10/2014 and was registered in ClinicalTrials.gov with the identification number NCT03732521. The study population were all patients with BPSD and their principal caregivers attended in the Cognitive and Behavioural Disorders Unit (CBDU) of HTVC who voluntarily agreed to participate though authorisation of informed consent after meeting the following selection criteria.
Inclusion criteria a Patients aged ≥ 65 years with a diagnosis of dementia and under treatment with acetylcholinesterase inhibitors and memantine for a minimum period of 6 months b Score between 4 and 6 on the Reisberg Global Severity Scale,17 both included. c Score ≥ 4 on the Neuropsychiatric Inventory scale (NPI10),18 with symptoms present at least one month prior to
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the visit, not attributable to intercurrent medical disease or acute confusional syndrome. d Residents in the family home attending the consultation accompanied by a principal caregiver who agreed to sign informed consent after obtaining all the information on the study in question. The principal caregiver is understood to be the relative who lives in the same home, is mainly responsible for the daily care of the patient and who accompanies him or her to visits to the health centre
Exclusion criteria a Patients with intercurrent medical illnesses that confer a life prognosis of less than 6 months b Patients whose BPSD may be in the context of a toxic-metabolic disease, uncontrolled pain or delirium, according to clinical criteria c Patients under treatment with typical neuroleptics, longacting benzodiazepines, major opioids or drugs that could potentially alter state of consciousness.
Data collection Socio-demographic variables such as age, sex, years of education and family history of psychiatric illness were collected. The clinical variables included type of dementia, years since diagnosis, cardiovascular risk factors (hypertension, diabetes mellitus, dyslipidaemia, overweight, smoking or alcohol habit and heart disease). In addition, functional variables were collected, pharmacological treatments for BPSD associated with dementia and the quantification and qualitative evaluation of BPSD classified as: resolved (R), improved (I), worsened (W), unchanged (U) and not present (NP). Neuropsychological variables were collected using the NPI-10, MMSE and Reisberg GDS scales. The NPI-10 inventory provides information on the presence of psychiatric and behavioural symptoms in patients with dementia, and explores 10 aspects: delusions, hallucinations, agitation, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviours. Each aspect or item includes one question, if it is answered in the affirmative, we move on to the next, and if answered in the negative, we move on to a subscale. The total score for the subscales is the product of frequency multiplied by severity. The MMSE was also used, which assesses mental states through the areas: orientation to time and space, immediate memory, attention and calculation, differed memory, language and praxis: nomination, repetition, understanding verbal instructions, reading, spontaneous writing and copying a drawing, and visual construction. The total score is obtained from the total number of correct answers, therefore the higher the score, the better the cognitive status, although the cut-off score is 24 and 27 according to the patients’ level of education. And finally, the Reisberg GDS, an instrument designed to detect the possible presence of depression, which comprises 30 items with dichotomous responses (yes/no). The total score is obtained from the sum of all the items, the interval is 0---30 and the
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cut-off points are: normal (0---10 points) and possible depression (11---30 points). Finally caregiver burden was assessed with the Zarit test, which comprises 22 questions; each item is assessed by frequency (never, rarely, sometimes, quite frequently, or nearly always) and the score ranges from 0 to 4. The total score is obtained from the sum of all the questions and the maximum score is 88 points. There are no standards or cut-off points, although ‘‘no burden’’ is considered if the score is less than 46 points and ‘‘intense burden’’ a score of more than 56.
Procedures, randomisation and recruitment After the patients were included in the study, they were variously randomised to the intervention group (IG) (routine clinical practice and educational nursing intervention in the family caregiver) or to the control group (CG) (routine clinical practice) with a ratio of 1:1 using the non-commercial Epidat 3.0 software (Xunta de Galicia and PHP/WHO). The sample size was calculated using free software (Granmo, Institut Municipal d’Investigació Mèdica, Barcelona), version 7.12. The calculation was made using the Zarit caregiver burden scale,19 accepting an alpha risk of .05 and a beta
Visit 1 (inclusion) Intervention group
Non-blinded neurologist
• Collection of the patients’ socio-demographic and clinical variables. Obtaining informed consent and randomisation
Control group
•
Patient scales (NPI-10, MMSE, Reisberg GDS, BPSD)
•
Caregiver scale (Zarit caregiver burden)
Visit 2 (Nursing consultation ± 15 days Intervention group
• • •
Visit 3 (Nursing by telephone± 30 days) Intervention group
• • •
Visit 4 (Nursing by telephone± 60 days) Intervention group
risk of less than .2 in bilateral contrast. Eighteen caregivers were assigned to the IG and 18 to the CG, to detect a difference equal to or greater than 4 points between the groups, with a 10% loss to follow-up rate. The patients and caregivers, after their allocation to the study group, were assessed by a neurologist who identified the presence of BPSD, adjusted their treatment and evaluated the NPI-10, MMSE, Reisberg GDS and Zarit scales. The total scores of the scales were recorded and in the case of the NPI-10, the value used was the result of multiplying frequency by severity. The IG caregivers were given an appointment after 15 days for a first consultation with the nurse who had the results of the scales and prior identification of the BPSD evaluated by the neurologist. The intervention nurse reviewed the BPSD of the first visit and then performed the educational intervention. There were telephone controls to reinforce the interventions and to assess for the onset of new BPSD at 30 and 60 days. Both groups were given appointments at 90 days with a new neurologist, blind to the allocation group, who re-evaluated the NPI-10, MMSE, Reisberg GDS and Zarit scales. A qualitative assessment of the BPSD submitted by the caregiver was performed using a response key classified as: R, I, W, U and NP (Fig. 1).
• • •
Visit 5 (final)
Intervention nurse BPSD review Individualised educational intervention to the caregiver according to the BPSD and written dossier given Appointment for telephone visit Intervention nurse BPSD review Individualised educational intervention to the caregiver according to the BPSD and written dossier given Appointment for telephone visit Intervention nurse BPSD review Individualised educational intervention to the caregiver according to the BPSD and written dossier given Appointment for telephone visit Blinded neurologist
Intervention group
•
Patient scales (NPI-10, MMSE, Reisberg GDS, BPSD)
Control group
•
Caregiver scale (Zarit caregiver burden)
* Face-to-face visit at the nursing clinic, if new needs, at the judgement of the investigating nurse
Figure 1 Timeline of the visits and assessments of the study. a Face-to-face visit at nurse consultation, if there were new needs in the opinion of the investigating nurse. Source: own preparation.
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Short title: Individual therapeutic-cognitive intervention of the psychological symptoms
Educational intervention The nursing team that delivered the educational interventions comprised 2 expert nurses from the CBDU, who had received training beforehand from a neuropsychological practitioner to ensure that their approach was homogenised. The BPSD had been defined beforehand, as well as the interventions for each case, with regard to attitude towards the patient and modification of the home environment where the symptom occurred (Table 1). All this was collected
Table 1
in a dossier that was then given to the principal caregivers of the IG with individualised adaptations according to the social and family context. Each face-to-face intervention lasted between 90 and 120 min, and the telephone visits lasted 30 min.
Management of the patients with dementia At the initial visit the neurologist adapted the medical treatment to each patient.
BPSD established for the study and behavioural interventions.
BPSD
Basic principles of behavioural interventions individualised for the caregivers of patients with dementia
Repetition
Do not ask them to repeat Reassure them Write down answers to repeated requests (if possible) Distract their attention Do not contradict or infantilise their actions Find a specific place to leave objects Keep the home tidy Make security copies Find the patient’s favourite place for hiding objects Lock cupboards Prevent them gaining access to valuable objects or documents In the event of a loss, accept it Do not leave large amounts of money within their reach Find activities to keep them busy Seek help from other people to help with personal tasks or rest Leave another trained caregiver, for a period of time Leave contact telephone numbers in case of emergency React calmly Take health complaints seriously Offer understanding Find simple activities to feel useful and safe Try to interest the patient in their surroundings Accept small tasks Stimulate in moderation Congratulate achievements and do not focus on what has not been achieved. Ask for feasible tasks Identify what makes them angry Offer emotional support Avoid things that do not make them comfortable, wellbeing Distract them if they are angry Simplify their surroundings and safety Avoid stressful situations Withdraw stimulants Respond affectionately Ensure secure and comfortable surroundings Create a calm atmosphere Look for flexible meals Avoid stimuli Avoid things they do not like Avoid contradicting Avoid conflict Convey calmness Use distraction to focus attention
Loss of or hiding objects
Persistent following of caregiver Complaints and insults against the caregiver
Depression
Apathy and indifference
Agitation
Anxiety, nervousness and unease
Worsening at night
Delusions
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S. Reverté-Villarroya et al. Table 1 (Continued) BPSD
Basic principles of behavioural interventions individualised for the caregivers of patients with dementia
Hallucinations
Only intervene if these are negative React calmly and serenely Do not combat them Do not reinforce them Use distraction Rule out problems with sight or hearing Do not argue Avoid hazards in their surroundings (close doors and balconies, etc.). Avoid siestas or short and long rests during the day Increase physical activity during the day Go to the bathroom before going to bed Try to make their bed and surroundings comfortable Avoid lights or use a blindfold during rest. Courtesy lights can be useful Try to coincide with rest hours Use prescription drugs Supervise diet, especially if the patient is self-caring Adapt meals and utensils to the patient’s needs Ensure set meal times Check dental prosthesis Close food cupboards and refrigerator Use prescribed dietary supplements
Sleep and diurnal rhythm disorders
Eating disorders
Source: own preparation. Adapted from Joling et al.27 , Olazarán et al.30 , Martín-Carrasco et al.34 , Bendicho Montés et al.35 , Hernández Ferrándiz36 and Ferré-Grau et al.37 .
Quetiapine or risperidone was used for hallucinations and delusions, according to the profile of comorbidities and tolerance of each patient. Low-dose citalopram, mirtazapine and, if no response, duloxetine or venlafaxine were used for depression or anxiety. The drug was chosen according to the patient’s comorbidities or tolerance. Short-acting low-dose benzodiazepines were only accepted if the patients had been taking them prior to their inclusion in the study (lorazepam or lormetazepam).20---24
Data analysis SPSS v23.0 for Windows (IBM) was used for the statistical analysis. All the tests were applied with 95% confidence. The results are presented in table form, with their respective absolute and relative frequencies. The numerical variables are represented by measures of central tendency and measures of dispersion described as mean ± standard deviation. The Shapiro-Wilk test for normality was used for the quantitative variables. The comparison between the initial visit and the final visit of the variables of the same group was carried out by means of the chi-squared and Student’s t-tests, according to the type of variables. Person’s correlation (normal distribution) and Spearman’s correlation (non-normal distribution) were used to compare the 2 groups.
Results Out of a total 36 dementia patients and their principal caregivers included in the study (18 in the CG and 18 in the IG), 28 participants completed the study (n = 15 in the GC and n = 13 in the IG). The reasons for loss to follow-up on the part of the caregiver were: medical reasons (n = 3), lack of time (n = 3), patient worsening (n = 1) and holiday period (n = 1). The socio-demographic characteristics of the participants and their principal caregivers are shown in Table 2. With regard to the patients, the total mean age was 78.96 ± 6.64) and 50% were male. Fourteen point three percent, had a psychiatric history at the time of their inclusion in the study, 50% were on some psychopharmacological treatment to control the BPSD associated with their dementia. Alzheimer’s disease was the main type of dementia (71.4%), followed by mixed4,21 and vascular1,7 dementia, with a mean disease duration from diagnosis of 2.11 ± 1.54 years. Fifty-seven point one percent had no cardiovascular risk factors, and of those who did (42.9%), the main risk factor was arterial hypertension (42.9%) followed by smoking (32.1%), overweight (32.1%) and dyslipidaemia (25.0%). In the caregiver sample, of which 92.9% were female, the mean age was 58.64 ± 11.69 and they had 8.36 ± 3.57 years of education. The distribution among the 2 study groups (relatives and caregivers) was similar, without obtaining statistical significance in the socio-demographic variables.
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Short title: Individual therapeutic-cognitive intervention of the psychological symptoms Table 2
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Baseline characteristics of the patients and their family caregivers.
Patient characteristics
Total (n = 28), n (%)
CG (n = 15), n (%)
IG (n = 13), n (%)
Sex Male Female
14 (50) 14 (50)
7 (46.7) 8 (53.3)
7 (53.8) 6 (46.2)
Psychiatric history Yes No
4 (14.3) 24 (85.7)
1 (6.7) 14 (93.3)
3 (23.1) 10 (76.9)
Type of dementia Alzheimer’s disease Vascular Mixed
20 (71.4) 2 (7.1) 6 (21.4)
11 (73.3) 0 4 (26.7)
9 (69.2) 2 (15.4) 2 (15.4)
Risk factors Yes Hypertension Diabetes mellitus Dyslipidaemia Smoking Alcohol use Overweight Heart disease No
12 (42.9) 12 (42.9) 5 (17.9) 7 (25.0) 9 (32.1) 2 (7.1) 9 (32.1) 6 (21.4) 16 (57.1)
4 (26.7) 6 (40.0) 3 (20.0) 4 (26.7) 5 (33.3) 1 (6.7) 5 (33.3) 3 (20.0) 11 (73.3)
8 6 2 3 4 1 4 3 5
(46.2) (46.2) (15.4) (23.1) (30.8) (7.7) (30.8) (23.1) (38.5)
Treatment for BPSD Mirtazapine Benzodiazepines Quetiapine SSRI Butyrophenones None
2 (7.1) 7 (25.0) 1 (3.6) 3 (10.7) 1 (3.6) 14 (50.0)
1 5 0 2 0 7
1 2 1 1 1 7
(7.7) (15.4) (7.7) (7.7) (7.7) (53.8)
Age (years)
Mean ± SD
Mean ± SD
Mean ± SD
p Value
Years since dementia diagnosis
78.96 ± 6.64 2.11 ± 1.54
79.20 ± 6.91 2.00 ± 1.41
78.69 ± 6.58 2.23 ± 1.72
.845 .701
Caregiver characteristics
Total (n = 28)
CG (n = 15)
IG (n = 13)
p Value
Age (years) Education (years)
Mean ± SD 58.64 ± 11.69 8.36 ± 3.57
Mean ± SD 58.53 ± 12.99 8.00 ± 3.89
Mean ± SD 58.77 ± 10.52 8.77 ± 3.27
.959 .580
n (%)
n (%)
n (%)
p Value
2 (7.1) 26 (92.9)
1 (6.7) 14 (93.3)
1 (7.7) 12 (92.3)
Sex Male Female
p Value .705
.216
.254
.063 .743 .750 .827 .615 .988 .885 .843 .069 .624
(6.7) (33.3) (13.3) (46.7)
.916
Chi-squared test. Significant correlation p value (<.05).
Comparison of the scores obtained on the patient scales (MMSE and GDS) showed significant differences between the IG and the CG comparing the initial visit with the followup visit at 3 months. It was observed that the MMSE score in the IG reduced significantly (p < .001) between the initial visit (16.92 ± 7.48) and the visit at 3 months (15.31 ± 6.18) compared to the CG, whose scores were 16.53 ± 5.02 at the initial visit and 16.53 ± 7.03 at the final visit, indicating a slight improvement in cognitive status. In terms of classification, no significant differences were observed.
The GDS scale also achieved significant results (p < .001), since the IG scored 4.85 ± .68 at the initial visit and 5.08 ± .76 at the final visit compared to the CG (5.07 ± .88 initial visit and 5.07 ± .88 fin. l visit), indicating a mild improvement in depressive symptoms. The NPI-10 scale did not obtain statistical significance (p = .419) but a tendency to improvement in the BPSD was observed in the IG (35.31 ± 17.05 initial visit vs.32.23 ± 21.57 fin. l visit), whereas the CG showed poorer results (24.33 ± 21.64 initial result vs. 29.26 ± 12.94 fin. l visit).
Comparison of the scores of the patient and caregiver scales, between the inclusion visit and at 90 days, according to assigned group. Scores on the scales Visit 1 (inclusion) Mean ± SD
Scores on the scales Visit 5 (final) Mean ± SD
Control group (n = 15)
Scores on the scales Visit 1 (inclusión) Mean ± SD
Scores on the scales Visit 5 (final) Mean ± SD
p Value
MMSE GDS Total NPI-10 Zarit
16.92 ± 7.48 4.85 ± .68 35.31 ± 17.05 52.38 ± 12.94
15.31 ± 6.18 5.08±.76 32.23 ± 21.57 59.08 ± 20.81
MMSE GDS NPI-10 total Zarit
16.53 ± 5.02 5.07 ± .88 24.33 ± 21.64 48.60 ± 19.16
16.53 ± 7.03 5.07 ± .88 29.26 ± 12.94 48.53 ± 15.72
.000**,b .000**,a .419a .010*,b
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Intervention group (n = 13)
[10pt] n (%) MMSE classification ≥ 27 (normal) ≤ 24 (pathological suspicion) 12-24 (deterioration) 9-12 (dementia) Zarit classification <47 (no burden) 47-55 (mild burden) >55 (intense burden) a b *
Chi-squared, Spearman’s correlation. Pearson’s correlation. p < .05. p < .01.
n (%)
2 (15.4) 0
1 (7.7) 1 (7.7)
5 (38.5) 6 (46.2)
7 (53.8) 4 (30.8)
4 (30.8) 3 (23.1) 6 (46.2)
3 (23.1) 3 (23.1) 7 (53.8)
MMSE classification ≥ 27 (normal) ≤ 24 (pathological suspicion) 12-24 (deterioration) 9-12 (dementia) Zarit classification <47 (no burden) 47-55 (mild burden) > 55 (intense burden)
n (%)
n (%)
0 1 (6.7)
0 2 (2 (13.3)
9 (60.0) 5 (33.3)
8 (53.3) 5 (33.3)
6 (40.0) 5 (33.3) 4 (26.7)
9 (60.0) 1 (6.7) 5 (33.3)
p value .250 .559
S. Reverté-Villarroya et al.
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Table 3
Visit 1, n (%) (n = 46)
Visit 5 and &, n (%) (n = 70)
BPSD (n = 29)
BPSD-CG (n = 15)
Visit 1, n (%) (n = 35)
Visit 5 and &, n (%) (n = 69)
BPSD (n = 35)
p Value
Repetition
1 (7.7)
2 (15.4) U
1a
Repetition
4(26.7)
.000b
---
3 1 1 1
(23.1) I (7.7) U (7.7) I (7.7) U
4a
---
3a
---
1a
.836
1 2 2 3 4
(7.7) R (15.4) I (15.4) U (23.1) R (30.8) U
1a
Loss or hiding of objects Persistent following of caregiver Complaints and insults against the caregiver Depression
(6.7) I (26.7) U (6.7) I (13.3) U (6.7) I (6.7) U
1a
Loss or hiding of objects Persistent following of caregiver
1 4 1 2 1 1 1 1 3 1 3 2 1 1 6 1 2 5 2 1 5 2 2 2
(6.7) R (6.7) I (20.0) U (6.7) R (20.0) U (13.3) W (7.1) R (7.1) U (35.8) W (6.7) R (13.3) U (33.3) W (13.3) R (6.7) I (33.3) U (13.3) W (13.3) U (13.3) W
1a
.534
3a
.013b
4a
.003b
3a
.349
8a
.764
---
.603
1 4 2 1 2 1 4
(6.7) R (26.7) U (13.3) W (6.7) R (13.3 U (6.7) W (26.7) U
4a
.565
4a
---
---
.006b
3a
.019b
1 (7.7)
1a
1 (6.7)
Complaints and insults against the caregiver Depression
4 (30.8)
Apathy and indifference
7 (53.8)
8 (61.5) U
1a
Apathy and indifference
4 (26.7)
Agitation
7 (53.8)
4 (30.8) I 6 (46.2) U
3a
Agitation
5 (33.3)
Anxiety, nervousness, restlessness
4 (30.8)
1 (7.7) R 1 (7.7) I 5 (38.5) U
3a
2 (13.3)
Worsening at night
6 (46.2)
1a
Delusions
2 (15.4)
6a
Delusions
3 (20.0)
Hallucinations
---
1 (7.7) R 2(15.4) I 2 (15.4) U 3 (23.1) R 1 (7.7) I 4 (30.8) U 1 (7.7) I 2 (15.4) U
Anxiety, nervousness and restlessness Worsening at night
3a
Hallucinations
1 (6.7)
Sleep and diurnal rhythm disorders
5 (38.5)
1a
5 (38.5)
Sleep and diurnal rhythm disorders Eating disorders
4 (26.7)
Eating disorders
1 1 2 1 1 3
4 (30.8)
(7.7) R (7.7) I (15.4) U (7.7) R (7.7) I (23.1) U
3a
1a
4 (26.7)
3 (20.0)
4 (26.7)
---
1 (6.7) R 2 (13.3) U
9
---: BPSD not present; &: key to classify the final assessment of BPSD: resolved (R), improved (I), worsened (W), unchanged (U) and not present (NP). a New BPSD identified in the intervention nurse visits in the IG and the final visit of the CG. b Significant correlation (p < .05).
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BPSD-GI (n = 13)
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BPSD identified from the inclusion visit up to 90 days, new onset BPSD, and assessment of final condition according to assigned group.
Short title: Individual therapeutic-cognitive intervention of the psychological symptoms
Table 4
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10 The Zarit principal caregiver burden scale also achieved statistically significant scores (p = .010) but in this case showed worsening in caregiver burden in the IG at the final visit (59.08 ± 20.81) compared to the initial visit (52.38 ± 12.94), whereas the CG obtained better scores (48.53 ± 15.72) vs. the initial visit (48.60 ± 19.16). Although no significance was obtained in the Zarit classification, it was observed that the IG showed mean scores of intense burden, while the CG had mild burden (Table 3). All the BPSD were identified that had been previously established in the study in both groups at the initial or final visit. When comparing the onset of new BPSD between the initial and final visit, and their evaluation between the groups, statistically significant differences in favour of the IG were observed for the BPSD: repetition (p < .001), depression (p = .013), apathy and indifference (p = .003), sleep and diurnal rhythm disorders (p = .006) and eating disorders (p = .019) (Table 4). In addition, in the IG there was no worsening of any of the BPSD at the final assessment: 6 of the BPSD were classified as resolved in some cases and 29 new cases were identified between the visits. On the other hand, the CG showed resolutions of the initial BPSD, worsening of 7 BPSD and increased by 35 new cases of different BPSD at 3 months.
Limitations of the study The detection and recruitment of the patients and their caregivers formed part of routine care, and therefore selection bias cannot be ruled out in addition to the difficulty in meeting the inclusion criteria for patient selection. The sex of the caregivers was unbalanced, as was the degree of caregiver overload. Loss to follow-up affected both groups, thus reducing the total number of participants and, in turn, influenced the subsequent analysis of the results. Due to the variability of the BPSD associated with dementia and their subtypes, the interventions shown in this paper focussed on the basic principles of their approach, which may affect the external validity of the study. Finally, a short period of intervention and follow-up in both groups was estimated, which might affect the assessment of the impact of the intervention.
Discussion and conclusions The clinical and socio-demographic profile of the patients and their main caregivers included in this study is comparable to that of other studies carried out in populations with dementia, other neurodegenerative diseases or, in general, dependent patients.1,3,4,25 When BPSD appear in patients with dementia, their family caregiver reports an inability or difficulty in managing them, which generates stress and overload in the process, and coping difficulties for them and the patient.26---28 There are studies that show the benefit of the use of NPI in patients with dementia. These include individual behavioural educational interventions aimed at improving BPSD or caregiver wellbeing.29,30 Unfortunately, although BPSD are identified in the daily clinical practice of cognitive disorder units, NPI is not included in the care routine of nurse consultations,31,32
S. Reverté-Villarroya et al. therefore studies that assess its impact have certain limitations.28 In our study, we detected significant differences in the MMSE and the GDS in favour of the IG, indicating slight improvement in the cognitive and depressive state of the patients at the final study visit compared to the initial visit. Differences were also found in the caregiver burden test. However, this was not to the benefit of the IG caregivers; perhaps because curiously they showed greater overload from the outset. This fact might have influenced the results, since although the NPI-10 scale was not significant, it did show a decrease in BPSD in the IG. It is possible that the caregivers who benefit most from NPI are the most overburdened and, in turn, although improvements are observed directly in the caregiver burden scales or the identification of BPSD, they do indirectly reflect the cognitive and depressive improvement of the patient. A greater number of BPSD were identified in the IG inclusion visit, although, by contrast, in the final visit both groups were equal. The BPSD with the best prognosis in favour of behavioural educational intervention significantly centred in the IG group and in the BPSD of repetition, depression, apathy and indifference, sleep and diurnal rhythm disorders, and eating disorders, all of which had greater impact on patients with dementia and coincide with other studies.14,29,33,34 Therefore, no BPSD in the IG worsened at the final assessment, unlike in the CG. Despite the above limitations, this study adds further to the benefits of individual behavioural interventions of an educational nature directed at principal caregivers and performed by an expert nurse in patient management. For this reason, it is recommended that individual educational and behavioural NPI in BPSD should be included in cognitive disorder units, in the nursing care model or plan, from a multidisciplinary perspective in order to respond to the real and tangible needs of principal caregivers.
Funding Spanish Society of Neurological Nursing. Research Prize. 20th Annual Congress, 2013.
Conflict of interests The authors have no conflict of interests to declare.
Acknowledgements This paper was completed with the help of Rosa Benet-Martí and Sonia Gálvez-Vicente. We would like to thank Dr. Juan José Baiges-Octavio for his collaboration and the rest of the HTVC Neurology Department team for their support in the execution and scientific review.
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ORIGINAL ARTICLE
Individual therapeutic-cognitive intervention of the psychological and behavioural symptoms of patients with dementia (PRESTA study)夽 Sílvia Reverté-Villarroya a,b,∗ , Josep Zaragoza-Brunet b , Calamanda Matamoros-Obiol b , Ester Inglada-García b , Sonia Escalante-Arroyo b , Eva Forcadell-Ferreres b , Patricia Esteve-Belloch b a
Facultad de Enfermería, Departamento de Enfermería, Universitat Rovira i Virgili (URV), Tortosa, Tarragona, Spain Servicio de Neurología, Hospital de Tortosa Verge de la Cinta, Instituto de Investigación Sanitaria Pere i Virgili (IISPV), Tortosa, Tarragona, Spain
b
Received 14 February 2019; accepted 20 August 2019
KEYWORDS Dementia; Behavioral symptoms; Caregivers; Educational assessment; Nursing care
Abstract Introduction: The behavioral and psychological symptoms of dementia (BPSD) frequently appear associated with patients with dementia, aggravating their cognitive and behavioral status, which generates anguish for their main caregivers. Non-pharmacological therapies are a method to approach BPSD. Aim: To analyze the effectiveness of a behavioral educational intervention and support to the family caregiver on the reduction of its overload, and if this reduction has a positive impact on BPSD of the patient with dementia. Methods: A randomized, controlled, double-blind trial was conducted with patients with dementia and their principal caregivers (PC). The PC were randomized to the intervention group (IG) or control (CG). The intervention consisted an individual cognitive-behavioral education performed by outpatient nursing, with periodic telephone contacts, during 3 months. CG received treatment as usual. Cognitive function was assessed using the cognitive scale MiniMental State Exploration (MMSE), Neuropsychiatric inventory (NPI-10) and depressive Geriatric Depression Scale (GDS). And caregiver reported burden through (Zarit Caregiver Burden Inventory). The Quantitative and qualitative data of SPCD’s were collected at baseline and after the intervention. Results: The mean total age of patients was 78.96 (± 6.64) years and 50% were men. And in PC (n = 28) of 58.64 (± 11.69) years, and 92.9% were women. The IG (n = 13) showed better
PII of original article: S2013-5246(19)30015-7 夽 Please cite this article as: Reverté-Villarroya S, Zaragoza-Brunet J, Matamoros-Obiol C, Inglada-García E, Escalante-Arroyo S, ForcadellFerreres E, et al. Intervención terapéutico-cognitiva individual de los síntomas psicológicos y conductuales de pacientes con demencia (estudio PRESTA). Rev Cient Soc Esp Enferm Neurol. 2019. https://doi.org/10.1016/j.sedene.2019.08.001 ∗ Corresponding author. E-mail address: [email protected] (S. Reverté-Villarroya). 2530-299X/© 2019 Sociedad Espa˜ nola de Enfermer´ıa Neurol´ ogica. Published by Elsevier Espa˜ na, S.L.U. All rights reserved.
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S. Reverté-Villarroya et al. score than the CG (n = 15) in the MMSE p < 0,001 and the GDS p < 0,001, although without changes in the NPI-10 (p = 0,419), between the start visit and at 3 months, indicating improvement cognitive and depressive after the intervention. The PC also obtained statistically significant scores in the Zarit (p = 0,010). SPCD’s improved significantly in GI: repetition p < 0,001, depression (p = 0,013), apathy and indifference (p = 0,003), sleep and diurnal rhythm disorders (p = 0,006) and eating disorders (p = 0,019) at 3 months. Clinicaltrials.gov Identifier: NCT03732521. Conclusions: The non-pharmacological therapy of individual therapeutic-cognitive intervention directed to caregivers and carried out by nursing personnel expert in its management, has a favorable impact in the control and reduction of the SPCD of patients with dementia. © 2019 Sociedad Espa˜ nola de Enfermer´ıa Neurol´ ogica. Published by Elsevier Espa˜ na, S.L.U. All rights reserved.
PALABRAS CLAVE Demencia; Síntomas psicológicos y conductuales; Cuidadores; Intervención educativa; Cuidados de enfermería
Intervención terapéutico-cognitiva individual de los síntomas psicológicos y conductuales de pacientes con demencia (estudio PRESTA) Resumen Introducción: Los síntomas psicológicos y conductuales de las demencias (SPCD) aparecen con frecuencia asociados a los pacientes con demencia, agravando su estado cognitivo y conductual, que genera angustia a sus cuidadores principales. Las terapias no farmacológicas, son un método para abordar los SPCD. Objetivo: Analizar la eficacia de una intervención terapéutica-conductual y de apoyo al cuidador familiar sobre la reducción de su sobrecarga, y si dicha reducción tiene un impacto positivo sobre los SPCD del paciente con demencia. Método: Ensayo clínico, randomizado, doble ciego e una muestra de pacientes con demencia y sus cuidadores principales (CP). Los CP fueron asignados a un grupo de intervención (GI) y control (GC). La intervención consistió en una educación cognitiva-conductual individual realizada por enfermería ambulatoria, con controles periódicos telefónicos durante 3 meses. El GC recibió la atención de práctica clínica habitual. Fue evaluada la función cognitiva: escala Mini-Mental (MMSE), y Neuropsychiatric inventory (NPI-10), la depresiva: escala depresión Geriátrica (GDS) y sobrecarga del cuidador: escala Zarit. Los SPCD fueron recogidos según datos cuantitativos y cualitativos en la visita inicial y final. Resultados: Edad media total de pacientes 78,96 (±6,64) a˜ nos y distribución por sexos (50%) hombres. Los CP (n = 28), mostró una edad media de 58,64 (±11,69) a˜ nos, siendo la práctica totalidad (92.9%) mujeres. El GI (n = 13) mostró mejor puntuación que el GC (n = 15) entre visitas (inicial y 3 meses), tanto en el MMSE p < 0,001 como en la GDS p < 0,001, aunque sin cambios en la NPI-10 (p = 0,419), indicando mejoría cognitiva y depresiva tras la intervención. Los cuidadores también obtuvieron puntuaciones estadísticamente significativas en el Zarit (p = 0,010). Los SPCD mejoraron en el GI: repetición p < 0,001, depresión (p = 0,013), apatía e indiferencia (p = 0,003), trastornos del sue˜ no y del ritmo diurno (p = 0,006) y trastornos de la alimentación (p = 0,019) a los 3 meses. Identificador Clinicaltrial.gov: NCT03732521. Conclusiones: La terapia no farmacológica de intervención terapéutica-cognitiva individual dirigida a cuidadores y conducida por personal de enfermería experto en su manejo, tiene un impacto favorable en el control y reducción de los SPCD de los pacientes con demencia. © 2019 Sociedad Espa˜ nola de Enfermer´ıa Neurol´ ogica. Publicado por Elsevier Espa˜ na, S.L.U. Todos los derechos reservados.
Introduction Dementia is a neuropsychiatric syndrome with a peak incidence from the age of 65.1 In 2015, an estimated 47 million people worldwide had dementia, and if its prevalence persists, this will be 130 million by 2050, all influenced by the increase in longevity and survival in the population.2
One of the main characteristics of dementia is cognitive deterioration with progressive impairment in daily functions often associated with behavioural alterations. Hence the onset of the behavioural and psychological symptoms of dementia (BPSD), defined as ‘‘disturbed perception, thought content, mood, and behaviour’’.3 These disturbances, such as agitation, depression, euphoria, delirium and hallucinations, are related to each other. Approximately 5 out of 6
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Short title: Individual therapeutic-cognitive intervention of the psychological symptoms patients with dementia will develop BPSD.4,5 Twenty percent of people will start with BPSD in the first 2 years after a diagnosis of dementia and at least 50% will develop new BPSD every month.6 BPSD such as agitation can present for several months in 50%---80% of cases. These symptoms are the manifestations that cause patients, their caregivers and society in general the most distress.7 Moreover, the 2 symptomatic spheres (cognitive and functional) worsen, which entails a higher economic cost, stress to caregivers, functional disability and decreased quality of life (of caregivers and patients), all of which precipitates the early institutionalisation of patients with dementia.8,9 In general, the therapeutic approach to BPSD should be multidisciplinary and coordinated at different levels of care, combining both pharmacological and non-pharmacological interventions (NPIs).10,11 NPIs in dementia are part of the biopsychosocial model of patient care.12 Compared to drugs, they have a more favourable side effect profile due to the added value of social contact and possibility of greater individualisation.13---15 We found evidence in the literature on the efficacy of outpatient educational interventions in family caregivers in reducing overload and improving mood15,16 but little is known as to whether this improvement might have an indirect impact on the patient’s BPSD, or on their caregiver. Thus, the objective of this study was to analyse the efficacy of an individual behavioural educational intervention and support provided to the family caregiver in reducing their overload and whether such reduction has a positive impact on the BPSD of the patient with dementia.
Methods Design and study population A clinical, randomised, double-blind and comparative trial was conducted among a sample of patients with dementia who received isolated medical treatment compared with another group with treatment plus an educational intervention by a nurse to support the main caregiver at the Hospital de Tortosa Verge de la Cinta (HTVC), from March 2014 to November 2017. The study obtained the approval of the reference Clinical Research Ethics Committee with the code CEIC-10/2014 and was registered in ClinicalTrials.gov with the identification number NCT03732521. The study population were all patients with BPSD and their principal caregivers attended in the Cognitive and Behavioural Disorders Unit (CBDU) of HTVC who voluntarily agreed to participate though authorisation of informed consent after meeting the following selection criteria.
Inclusion criteria a Patients aged ≥ 65 years with a diagnosis of dementia and under treatment with acetylcholinesterase inhibitors and memantine for a minimum period of 6 months b Score between 4 and 6 on the Reisberg Global Severity Scale,17 both included. c Score ≥ 4 on the Neuropsychiatric Inventory scale (NPI10),18 with symptoms present at least one month prior to
3
the visit, not attributable to intercurrent medical disease or acute confusional syndrome. d Residents in the family home attending the consultation accompanied by a principal caregiver who agreed to sign informed consent after obtaining all the information on the study in question. The principal caregiver is understood to be the relative who lives in the same home, is mainly responsible for the daily care of the patient and who accompanies him or her to visits to the health centre
Exclusion criteria a Patients with intercurrent medical illnesses that confer a life prognosis of less than 6 months b Patients whose BPSD may be in the context of a toxic-metabolic disease, uncontrolled pain or delirium, according to clinical criteria c Patients under treatment with typical neuroleptics, longacting benzodiazepines, major opioids or drugs that could potentially alter state of consciousness.
Data collection Socio-demographic variables such as age, sex, years of education and family history of psychiatric illness were collected. The clinical variables included type of dementia, years since diagnosis, cardiovascular risk factors (hypertension, diabetes mellitus, dyslipidaemia, overweight, smoking or alcohol habit and heart disease). In addition, functional variables were collected, pharmacological treatments for BPSD associated with dementia and the quantification and qualitative evaluation of BPSD classified as: resolved (R), improved (I), worsened (W), unchanged (U) and not present (NP). Neuropsychological variables were collected using the NPI-10, MMSE and Reisberg GDS scales. The NPI-10 inventory provides information on the presence of psychiatric and behavioural symptoms in patients with dementia, and explores 10 aspects: delusions, hallucinations, agitation, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviours. Each aspect or item includes one question, if it is answered in the affirmative, we move on to the next, and if answered in the negative, we move on to a subscale. The total score for the subscales is the product of frequency multiplied by severity. The MMSE was also used, which assesses mental states through the areas: orientation to time and space, immediate memory, attention and calculation, differed memory, language and praxis: nomination, repetition, understanding verbal instructions, reading, spontaneous writing and copying a drawing, and visual construction. The total score is obtained from the total number of correct answers, therefore the higher the score, the better the cognitive status, although the cut-off score is 24 and 27 according to the patients’ level of education. And finally, the Reisberg GDS, an instrument designed to detect the possible presence of depression, which comprises 30 items with dichotomous responses (yes/no). The total score is obtained from the sum of all the items, the interval is 0---30 and the
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cut-off points are: normal (0---10 points) and possible depression (11---30 points). Finally caregiver burden was assessed with the Zarit test, which comprises 22 questions; each item is assessed by frequency (never, rarely, sometimes, quite frequently, or nearly always) and the score ranges from 0 to 4. The total score is obtained from the sum of all the questions and the maximum score is 88 points. There are no standards or cut-off points, although ‘‘no burden’’ is considered if the score is less than 46 points and ‘‘intense burden’’ a score of more than 56.
Procedures, randomisation and recruitment After the patients were included in the study, they were variously randomised to the intervention group (IG) (routine clinical practice and educational nursing intervention in the family caregiver) or to the control group (CG) (routine clinical practice) with a ratio of 1:1 using the non-commercial Epidat 3.0 software (Xunta de Galicia and PHP/WHO). The sample size was calculated using free software (Granmo, Institut Municipal d’Investigació Mèdica, Barcelona), version 7.12. The calculation was made using the Zarit caregiver burden scale,19 accepting an alpha risk of .05 and a beta
Visit 1 (inclusion) Intervention group
Non-blinded neurologist
• Collection of the patients’ socio-demographic and clinical variables. Obtaining informed consent and randomisation
Control group
•
Patient scales (NPI-10, MMSE, Reisberg GDS, BPSD)
•
Caregiver scale (Zarit caregiver burden)
Visit 2 (Nursing consultation ± 15 days Intervention group
• • •
Visit 3 (Nursing by telephone± 30 days) Intervention group
• • •
Visit 4 (Nursing by telephone± 60 days) Intervention group
risk of less than .2 in bilateral contrast. Eighteen caregivers were assigned to the IG and 18 to the CG, to detect a difference equal to or greater than 4 points between the groups, with a 10% loss to follow-up rate. The patients and caregivers, after their allocation to the study group, were assessed by a neurologist who identified the presence of BPSD, adjusted their treatment and evaluated the NPI-10, MMSE, Reisberg GDS and Zarit scales. The total scores of the scales were recorded and in the case of the NPI-10, the value used was the result of multiplying frequency by severity. The IG caregivers were given an appointment after 15 days for a first consultation with the nurse who had the results of the scales and prior identification of the BPSD evaluated by the neurologist. The intervention nurse reviewed the BPSD of the first visit and then performed the educational intervention. There were telephone controls to reinforce the interventions and to assess for the onset of new BPSD at 30 and 60 days. Both groups were given appointments at 90 days with a new neurologist, blind to the allocation group, who re-evaluated the NPI-10, MMSE, Reisberg GDS and Zarit scales. A qualitative assessment of the BPSD submitted by the caregiver was performed using a response key classified as: R, I, W, U and NP (Fig. 1).
• • •
Visit 5 (final)
Intervention nurse BPSD review Individualised educational intervention to the caregiver according to the BPSD and written dossier given Appointment for telephone visit Intervention nurse BPSD review Individualised educational intervention to the caregiver according to the BPSD and written dossier given Appointment for telephone visit Intervention nurse BPSD review Individualised educational intervention to the caregiver according to the BPSD and written dossier given Appointment for telephone visit Blinded neurologist
Intervention group
•
Patient scales (NPI-10, MMSE, Reisberg GDS, BPSD)
Control group
•
Caregiver scale (Zarit caregiver burden)
* Face-to-face visit at the nursing clinic, if new needs, at the judgement of the investigating nurse
Figure 1 Timeline of the visits and assessments of the study. a Face-to-face visit at nurse consultation, if there were new needs in the opinion of the investigating nurse. Source: own preparation.
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Short title: Individual therapeutic-cognitive intervention of the psychological symptoms
Educational intervention The nursing team that delivered the educational interventions comprised 2 expert nurses from the CBDU, who had received training beforehand from a neuropsychological practitioner to ensure that their approach was homogenised. The BPSD had been defined beforehand, as well as the interventions for each case, with regard to attitude towards the patient and modification of the home environment where the symptom occurred (Table 1). All this was collected
Table 1
in a dossier that was then given to the principal caregivers of the IG with individualised adaptations according to the social and family context. Each face-to-face intervention lasted between 90 and 120 min, and the telephone visits lasted 30 min.
Management of the patients with dementia At the initial visit the neurologist adapted the medical treatment to each patient.
BPSD established for the study and behavioural interventions.
BPSD
Basic principles of behavioural interventions individualised for the caregivers of patients with dementia
Repetition
Do not ask them to repeat Reassure them Write down answers to repeated requests (if possible) Distract their attention Do not contradict or infantilise their actions Find a specific place to leave objects Keep the home tidy Make security copies Find the patient’s favourite place for hiding objects Lock cupboards Prevent them gaining access to valuable objects or documents In the event of a loss, accept it Do not leave large amounts of money within their reach Find activities to keep them busy Seek help from other people to help with personal tasks or rest Leave another trained caregiver, for a period of time Leave contact telephone numbers in case of emergency React calmly Take health complaints seriously Offer understanding Find simple activities to feel useful and safe Try to interest the patient in their surroundings Accept small tasks Stimulate in moderation Congratulate achievements and do not focus on what has not been achieved. Ask for feasible tasks Identify what makes them angry Offer emotional support Avoid things that do not make them comfortable, wellbeing Distract them if they are angry Simplify their surroundings and safety Avoid stressful situations Withdraw stimulants Respond affectionately Ensure secure and comfortable surroundings Create a calm atmosphere Look for flexible meals Avoid stimuli Avoid things they do not like Avoid contradicting Avoid conflict Convey calmness Use distraction to focus attention
Loss of or hiding objects
Persistent following of caregiver Complaints and insults against the caregiver
Depression
Apathy and indifference
Agitation
Anxiety, nervousness and unease
Worsening at night
Delusions
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S. Reverté-Villarroya et al. Table 1 (Continued) BPSD
Basic principles of behavioural interventions individualised for the caregivers of patients with dementia
Hallucinations
Only intervene if these are negative React calmly and serenely Do not combat them Do not reinforce them Use distraction Rule out problems with sight or hearing Do not argue Avoid hazards in their surroundings (close doors and balconies, etc.). Avoid siestas or short and long rests during the day Increase physical activity during the day Go to the bathroom before going to bed Try to make their bed and surroundings comfortable Avoid lights or use a blindfold during rest. Courtesy lights can be useful Try to coincide with rest hours Use prescription drugs Supervise diet, especially if the patient is self-caring Adapt meals and utensils to the patient’s needs Ensure set meal times Check dental prosthesis Close food cupboards and refrigerator Use prescribed dietary supplements
Sleep and diurnal rhythm disorders
Eating disorders
Source: own preparation. Adapted from Joling et al.27 , Olazarán et al.30 , Martín-Carrasco et al.34 , Bendicho Montés et al.35 , Hernández Ferrándiz36 and Ferré-Grau et al.37 .
Quetiapine or risperidone was used for hallucinations and delusions, according to the profile of comorbidities and tolerance of each patient. Low-dose citalopram, mirtazapine and, if no response, duloxetine or venlafaxine were used for depression or anxiety. The drug was chosen according to the patient’s comorbidities or tolerance. Short-acting low-dose benzodiazepines were only accepted if the patients had been taking them prior to their inclusion in the study (lorazepam or lormetazepam).20---24
Data analysis SPSS v23.0 for Windows (IBM) was used for the statistical analysis. All the tests were applied with 95% confidence. The results are presented in table form, with their respective absolute and relative frequencies. The numerical variables are represented by measures of central tendency and measures of dispersion described as mean ± standard deviation. The Shapiro-Wilk test for normality was used for the quantitative variables. The comparison between the initial visit and the final visit of the variables of the same group was carried out by means of the chi-squared and Student’s t-tests, according to the type of variables. Person’s correlation (normal distribution) and Spearman’s correlation (non-normal distribution) were used to compare the 2 groups.
Results Out of a total 36 dementia patients and their principal caregivers included in the study (18 in the CG and 18 in the IG), 28 participants completed the study (n = 15 in the GC and n = 13 in the IG). The reasons for loss to follow-up on the part of the caregiver were: medical reasons (n = 3), lack of time (n = 3), patient worsening (n = 1) and holiday period (n = 1). The socio-demographic characteristics of the participants and their principal caregivers are shown in Table 2. With regard to the patients, the total mean age was 78.96 ± 6.64) and 50% were male. Fourteen point three percent, had a psychiatric history at the time of their inclusion in the study, 50% were on some psychopharmacological treatment to control the BPSD associated with their dementia. Alzheimer’s disease was the main type of dementia (71.4%), followed by mixed4,21 and vascular1,7 dementia, with a mean disease duration from diagnosis of 2.11 ± 1.54 years. Fifty-seven point one percent had no cardiovascular risk factors, and of those who did (42.9%), the main risk factor was arterial hypertension (42.9%) followed by smoking (32.1%), overweight (32.1%) and dyslipidaemia (25.0%). In the caregiver sample, of which 92.9% were female, the mean age was 58.64 ± 11.69 and they had 8.36 ± 3.57 years of education. The distribution among the 2 study groups (relatives and caregivers) was similar, without obtaining statistical significance in the socio-demographic variables.
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Short title: Individual therapeutic-cognitive intervention of the psychological symptoms Table 2
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Baseline characteristics of the patients and their family caregivers.
Patient characteristics
Total (n = 28), n (%)
CG (n = 15), n (%)
IG (n = 13), n (%)
Sex Male Female
14 (50) 14 (50)
7 (46.7) 8 (53.3)
7 (53.8) 6 (46.2)
Psychiatric history Yes No
4 (14.3) 24 (85.7)
1 (6.7) 14 (93.3)
3 (23.1) 10 (76.9)
Type of dementia Alzheimer’s disease Vascular Mixed
20 (71.4) 2 (7.1) 6 (21.4)
11 (73.3) 0 4 (26.7)
9 (69.2) 2 (15.4) 2 (15.4)
Risk factors Yes Hypertension Diabetes mellitus Dyslipidaemia Smoking Alcohol use Overweight Heart disease No
12 (42.9) 12 (42.9) 5 (17.9) 7 (25.0) 9 (32.1) 2 (7.1) 9 (32.1) 6 (21.4) 16 (57.1)
4 (26.7) 6 (40.0) 3 (20.0) 4 (26.7) 5 (33.3) 1 (6.7) 5 (33.3) 3 (20.0) 11 (73.3)
8 6 2 3 4 1 4 3 5
(46.2) (46.2) (15.4) (23.1) (30.8) (7.7) (30.8) (23.1) (38.5)
Treatment for BPSD Mirtazapine Benzodiazepines Quetiapine SSRI Butyrophenones None
2 (7.1) 7 (25.0) 1 (3.6) 3 (10.7) 1 (3.6) 14 (50.0)
1 5 0 2 0 7
1 2 1 1 1 7
(7.7) (15.4) (7.7) (7.7) (7.7) (53.8)
Age (years)
Mean ± SD
Mean ± SD
Mean ± SD
p Value
Years since dementia diagnosis
78.96 ± 6.64 2.11 ± 1.54
79.20 ± 6.91 2.00 ± 1.41
78.69 ± 6.58 2.23 ± 1.72
.845 .701
Caregiver characteristics
Total (n = 28)
CG (n = 15)
IG (n = 13)
p Value
Age (years) Education (years)
Mean ± SD 58.64 ± 11.69 8.36 ± 3.57
Mean ± SD 58.53 ± 12.99 8.00 ± 3.89
Mean ± SD 58.77 ± 10.52 8.77 ± 3.27
.959 .580
n (%)
n (%)
n (%)
p Value
2 (7.1) 26 (92.9)
1 (6.7) 14 (93.3)
1 (7.7) 12 (92.3)
Sex Male Female
p Value .705
.216
.254
.063 .743 .750 .827 .615 .988 .885 .843 .069 .624
(6.7) (33.3) (13.3) (46.7)
.916
Chi-squared test. Significant correlation p value (<.05).
Comparison of the scores obtained on the patient scales (MMSE and GDS) showed significant differences between the IG and the CG comparing the initial visit with the followup visit at 3 months. It was observed that the MMSE score in the IG reduced significantly (p < .001) between the initial visit (16.92 ± 7.48) and the visit at 3 months (15.31 ± 6.18) compared to the CG, whose scores were 16.53 ± 5.02 at the initial visit and 16.53 ± 7.03 at the final visit, indicating a slight improvement in cognitive status. In terms of classification, no significant differences were observed.
The GDS scale also achieved significant results (p < .001), since the IG scored 4.85 ± .68 at the initial visit and 5.08 ± .76 at the final visit compared to the CG (5.07 ± .88 initial visit and 5.07 ± .88 fin. l visit), indicating a mild improvement in depressive symptoms. The NPI-10 scale did not obtain statistical significance (p = .419) but a tendency to improvement in the BPSD was observed in the IG (35.31 ± 17.05 initial visit vs.32.23 ± 21.57 fin. l visit), whereas the CG showed poorer results (24.33 ± 21.64 initial result vs. 29.26 ± 12.94 fin. l visit).
Comparison of the scores of the patient and caregiver scales, between the inclusion visit and at 90 days, according to assigned group. Scores on the scales Visit 1 (inclusion) Mean ± SD
Scores on the scales Visit 5 (final) Mean ± SD
Control group (n = 15)
Scores on the scales Visit 1 (inclusión) Mean ± SD
Scores on the scales Visit 5 (final) Mean ± SD
p Value
MMSE GDS Total NPI-10 Zarit
16.92 ± 7.48 4.85 ± .68 35.31 ± 17.05 52.38 ± 12.94
15.31 ± 6.18 5.08±.76 32.23 ± 21.57 59.08 ± 20.81
MMSE GDS NPI-10 total Zarit
16.53 ± 5.02 5.07 ± .88 24.33 ± 21.64 48.60 ± 19.16
16.53 ± 7.03 5.07 ± .88 29.26 ± 12.94 48.53 ± 15.72
.000**,b .000**,a .419a .010*,b
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Intervention group (n = 13)
[10pt] n (%) MMSE classification ≥ 27 (normal) ≤ 24 (pathological suspicion) 12-24 (deterioration) 9-12 (dementia) Zarit classification <47 (no burden) 47-55 (mild burden) >55 (intense burden) a b *
Chi-squared, Spearman’s correlation. Pearson’s correlation. p < .05. p < .01.
n (%)
2 (15.4) 0
1 (7.7) 1 (7.7)
5 (38.5) 6 (46.2)
7 (53.8) 4 (30.8)
4 (30.8) 3 (23.1) 6 (46.2)
3 (23.1) 3 (23.1) 7 (53.8)
MMSE classification ≥ 27 (normal) ≤ 24 (pathological suspicion) 12-24 (deterioration) 9-12 (dementia) Zarit classification <47 (no burden) 47-55 (mild burden) > 55 (intense burden)
n (%)
n (%)
0 1 (6.7)
0 2 (2 (13.3)
9 (60.0) 5 (33.3)
8 (53.3) 5 (33.3)
6 (40.0) 5 (33.3) 4 (26.7)
9 (60.0) 1 (6.7) 5 (33.3)
p value .250 .559
S. Reverté-Villarroya et al.
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Table 3
Visit 1, n (%) (n = 46)
Visit 5 and &, n (%) (n = 70)
BPSD (n = 29)
BPSD-CG (n = 15)
Visit 1, n (%) (n = 35)
Visit 5 and &, n (%) (n = 69)
BPSD (n = 35)
p Value
Repetition
1 (7.7)
2 (15.4) U
1a
Repetition
4(26.7)
.000b
---
3 1 1 1
(23.1) I (7.7) U (7.7) I (7.7) U
4a
---
3a
---
1a
.836
1 2 2 3 4
(7.7) R (15.4) I (15.4) U (23.1) R (30.8) U
1a
Loss or hiding of objects Persistent following of caregiver Complaints and insults against the caregiver Depression
(6.7) I (26.7) U (6.7) I (13.3) U (6.7) I (6.7) U
1a
Loss or hiding of objects Persistent following of caregiver
1 4 1 2 1 1 1 1 3 1 3 2 1 1 6 1 2 5 2 1 5 2 2 2
(6.7) R (6.7) I (20.0) U (6.7) R (20.0) U (13.3) W (7.1) R (7.1) U (35.8) W (6.7) R (13.3) U (33.3) W (13.3) R (6.7) I (33.3) U (13.3) W (13.3) U (13.3) W
1a
.534
3a
.013b
4a
.003b
3a
.349
8a
.764
---
.603
1 4 2 1 2 1 4
(6.7) R (26.7) U (13.3) W (6.7) R (13.3 U (6.7) W (26.7) U
4a
.565
4a
---
---
.006b
3a
.019b
1 (7.7)
1a
1 (6.7)
Complaints and insults against the caregiver Depression
4 (30.8)
Apathy and indifference
7 (53.8)
8 (61.5) U
1a
Apathy and indifference
4 (26.7)
Agitation
7 (53.8)
4 (30.8) I 6 (46.2) U
3a
Agitation
5 (33.3)
Anxiety, nervousness, restlessness
4 (30.8)
1 (7.7) R 1 (7.7) I 5 (38.5) U
3a
2 (13.3)
Worsening at night
6 (46.2)
1a
Delusions
2 (15.4)
6a
Delusions
3 (20.0)
Hallucinations
---
1 (7.7) R 2(15.4) I 2 (15.4) U 3 (23.1) R 1 (7.7) I 4 (30.8) U 1 (7.7) I 2 (15.4) U
Anxiety, nervousness and restlessness Worsening at night
3a
Hallucinations
1 (6.7)
Sleep and diurnal rhythm disorders
5 (38.5)
1a
5 (38.5)
Sleep and diurnal rhythm disorders Eating disorders
4 (26.7)
Eating disorders
1 1 2 1 1 3
4 (30.8)
(7.7) R (7.7) I (15.4) U (7.7) R (7.7) I (23.1) U
3a
1a
4 (26.7)
3 (20.0)
4 (26.7)
---
1 (6.7) R 2 (13.3) U
9
---: BPSD not present; &: key to classify the final assessment of BPSD: resolved (R), improved (I), worsened (W), unchanged (U) and not present (NP). a New BPSD identified in the intervention nurse visits in the IG and the final visit of the CG. b Significant correlation (p < .05).
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BPSD-GI (n = 13)
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BPSD identified from the inclusion visit up to 90 days, new onset BPSD, and assessment of final condition according to assigned group.
Short title: Individual therapeutic-cognitive intervention of the psychological symptoms
Table 4
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10 The Zarit principal caregiver burden scale also achieved statistically significant scores (p = .010) but in this case showed worsening in caregiver burden in the IG at the final visit (59.08 ± 20.81) compared to the initial visit (52.38 ± 12.94), whereas the CG obtained better scores (48.53 ± 15.72) vs. the initial visit (48.60 ± 19.16). Although no significance was obtained in the Zarit classification, it was observed that the IG showed mean scores of intense burden, while the CG had mild burden (Table 3). All the BPSD were identified that had been previously established in the study in both groups at the initial or final visit. When comparing the onset of new BPSD between the initial and final visit, and their evaluation between the groups, statistically significant differences in favour of the IG were observed for the BPSD: repetition (p < .001), depression (p = .013), apathy and indifference (p = .003), sleep and diurnal rhythm disorders (p = .006) and eating disorders (p = .019) (Table 4). In addition, in the IG there was no worsening of any of the BPSD at the final assessment: 6 of the BPSD were classified as resolved in some cases and 29 new cases were identified between the visits. On the other hand, the CG showed resolutions of the initial BPSD, worsening of 7 BPSD and increased by 35 new cases of different BPSD at 3 months.
Limitations of the study The detection and recruitment of the patients and their caregivers formed part of routine care, and therefore selection bias cannot be ruled out in addition to the difficulty in meeting the inclusion criteria for patient selection. The sex of the caregivers was unbalanced, as was the degree of caregiver overload. Loss to follow-up affected both groups, thus reducing the total number of participants and, in turn, influenced the subsequent analysis of the results. Due to the variability of the BPSD associated with dementia and their subtypes, the interventions shown in this paper focussed on the basic principles of their approach, which may affect the external validity of the study. Finally, a short period of intervention and follow-up in both groups was estimated, which might affect the assessment of the impact of the intervention.
Discussion and conclusions The clinical and socio-demographic profile of the patients and their main caregivers included in this study is comparable to that of other studies carried out in populations with dementia, other neurodegenerative diseases or, in general, dependent patients.1,3,4,25 When BPSD appear in patients with dementia, their family caregiver reports an inability or difficulty in managing them, which generates stress and overload in the process, and coping difficulties for them and the patient.26---28 There are studies that show the benefit of the use of NPI in patients with dementia. These include individual behavioural educational interventions aimed at improving BPSD or caregiver wellbeing.29,30 Unfortunately, although BPSD are identified in the daily clinical practice of cognitive disorder units, NPI is not included in the care routine of nurse consultations,31,32
S. Reverté-Villarroya et al. therefore studies that assess its impact have certain limitations.28 In our study, we detected significant differences in the MMSE and the GDS in favour of the IG, indicating slight improvement in the cognitive and depressive state of the patients at the final study visit compared to the initial visit. Differences were also found in the caregiver burden test. However, this was not to the benefit of the IG caregivers; perhaps because curiously they showed greater overload from the outset. This fact might have influenced the results, since although the NPI-10 scale was not significant, it did show a decrease in BPSD in the IG. It is possible that the caregivers who benefit most from NPI are the most overburdened and, in turn, although improvements are observed directly in the caregiver burden scales or the identification of BPSD, they do indirectly reflect the cognitive and depressive improvement of the patient. A greater number of BPSD were identified in the IG inclusion visit, although, by contrast, in the final visit both groups were equal. The BPSD with the best prognosis in favour of behavioural educational intervention significantly centred in the IG group and in the BPSD of repetition, depression, apathy and indifference, sleep and diurnal rhythm disorders, and eating disorders, all of which had greater impact on patients with dementia and coincide with other studies.14,29,33,34 Therefore, no BPSD in the IG worsened at the final assessment, unlike in the CG. Despite the above limitations, this study adds further to the benefits of individual behavioural interventions of an educational nature directed at principal caregivers and performed by an expert nurse in patient management. For this reason, it is recommended that individual educational and behavioural NPI in BPSD should be included in cognitive disorder units, in the nursing care model or plan, from a multidisciplinary perspective in order to respond to the real and tangible needs of principal caregivers.
Funding Spanish Society of Neurological Nursing. Research Prize. 20th Annual Congress, 2013.
Conflict of interests The authors have no conflict of interests to declare.
Acknowledgements This paper was completed with the help of Rosa Benet-Martí and Sonia Gálvez-Vicente. We would like to thank Dr. Juan José Baiges-Octavio for his collaboration and the rest of the HTVC Neurology Department team for their support in the execution and scientific review.
References 1. Garre-Olmo J. Epidemiología de la enfermedad de Alzheimer y otras demencias. Rev Neurol. 2018;66(11):377---86. Disponible a: http://www.ncbi.nlm.nih.gov/pubmed/29790571
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