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Evaluating the efficacy of a web-based program (diapason) for informal caregivers of patients with Alzheimer's disease: protocol for a randomized clinical trial.

ABSTRACT: BACKGROUND:Informal caregivers (CGs) of patients with Alzheimer's disease are at risk of suffering from psychological and physical weakening. Several psychoeducational interventions have been designed to prevent stress and burden of caregivers. In France, despite health authorities' recommendations, to our knowledge there is no rigorously assessed Web-based psychoeducational program to date. OBJECTIVE:The objective of our study was to assess the efficacy of a French Web-based psychoeducational program (called Diapason) with an unblinded randomized clinical trial. METHODS:In this protocol, 80 informal caregivers of patients followed at Broca Hospital are recruited offline and randomized in the experimental condition (EC) or the control condition (CC). The volunteers in EC have to visit a closed online user group at least once a week and validate one new session of this fully automated Web program, during 12 weeks. Each week a new thematic is added to the website. The participants in the CC receive usual care, and have access to the Diapason program after their participation (6 months). Face-to-face evaluations for both groups are planned every 3 months (M0-M3 and M6). The main objective of this program is to provide CGs with information on the disease process, how to prevent psychological strain (using anticipation and relaxation techniques), and offering a virtual space (forum) to discuss with other caregivers. The primary outcome of this study is the self-perceived stress, while self-efficacy, burden, depression, and self-perceived health status are defined as secondary outcomes. Other variables that might have an impact on the program efficacy are collected. RESULTS:This protocol was accepted for funding. The enrollment began in October 2011, and participants currently recruited will finish their evaluations in January 2014. The results are expected for June 2014. CONCLUSIONS:Findings might provide empirical evidence on: (1) the feasibility of an Internet-based program in the French context, (2) the effectiveness of a Web-based program for informal caregivers, and (3) the identification of caregivers who will benefit from this type of intervention. TRIAL REGISTRATION:Clinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).

SUBMITTER: Cristancho-Lacroix V

PROVIDER: S-EPMC3869082 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Evaluating the efficacy of a web-based program (diapason) for informal caregivers of patients with Alzheimer's disease: protocol for a randomized clinical trial.

Cristancho-Lacroix Victoria V Kerhervé Hélène H de Rotrou Jocelyne J Rouquette Alexandra A Legouverneur Grégory G Rigaud Anne-Sophie AS

JMIR research protocols 20131206 2

<h4>Background</h4>Informal caregivers (CGs) of patients with Alzheimer's disease are at risk of suffering from psychological and physical weakening. Several psychoeducational interventions have been designed to prevent stress and burden of caregivers. In France, despite health authorities' recommendations, to our knowledge there is no rigorously assessed Web-based psychoeducational program to date.<h4>Objective</h4>The objective of our study was to assess the efficacy of a French Web-based psyc ...[more]

PMID: 24317497

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Project description:Although several face-to-face programs are dedicated to informal caregivers of persons with dementia, they are not always accessible to overburdened or isolated caregivers. Based on a face-to-face intervention program, we adapted and designed a Web-based fully automated psychoeducational program (called Diapason) inspired by a cognitive approach.This study aimed to evaluate through a pilot unblinded randomized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer's disease (PWAD) based on a mixed methods research design.We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris, France. They either received the Web-based intervention and usual care for 3 months (experimental group, n=25) or only usual care (control group, n=24). Caregivers' perceived stress (PSS-14, primary outcome), self-efficacy, burden, perceived health status, and depression (secondary outcomes) were measured during 3 face-to-face on-site visits: at baseline, at the end of the program (month 3), and after follow-up (month 6). Additionally, semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis.Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups (P=.98). The experimental group significantly improved their knowledge of the illness (d=.79, P=.008) from baseline to month 3. Of the 25 participants allocated to the experimental group, 17 (71%) finished the protocol and entirely viewed at least 10 of 12 online sessions. On average, participants used the website 19.72 times (SD 12.88) and were connected for 262.20 minutes (SD 270.74). The results of the satisfaction questionnaire showed that most participants considered the program to be useful (95%, 19/20), clear (100%, 20/20), and comprehensive (85%, 17/20). Significant correlations were found between relationship and caregivers' program opinion (P=.01). Thus, positive opinions were provided by husbands and sons (3/3), whereas qualified opinions were primarily reported by daughters (8/11). Female spouses expressed negative (2/3) or neutral opinions (1/3). Caregivers expected more dynamic content and further interaction with staff and peers.In this study, quantitative results were inconclusive owing to small sample size. Qualitative results indicated/showed little acceptance of the program and high expectations from caregivers. Caregivers did not rule out their interest in this kind of intervention provided that it met their needs. More dynamic, personalized, and social interventions are desirable. Our recruitment issues pointed out the necessity of in-depth studies about caregivers' help-seeking behaviors and readiness factors.Clinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).

Project description:BackgroundCaregiving for a family member can result in reduced well-being for the caregiver. Internet-delivered cognitive behavioral therapy (ICBT) may be one way to support this population. This is especially the case for caregivers in countries with limited resources, but high demand for psychological services.ObjectiveIn this study we evaluated the effects of a therapist-guided 8-week-long ICBT intervention for informal caregivers.MethodsIn total, 63 participants were recruited online and randomized either to the intervention or to the wait-list control group. The main study outcome was the Caregiver Burden Inventory (CBI). Secondary outcomes included measures of caregiver depression, anxiety, stress, and quality of life.ResultsModerate between-group effect sizes were observed for the CBI measure, in favor of the intervention group, with a Cohen d=-0.70 for the intention-to-treat analysis. Analyses of the subscales of the CBI showed significant reductions on the subscales of Development and Physical Health. Moderate reductions were found for depression and anxiety scores as indicated by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scores. Large between-group effects were observed for reduction in stress and increase in quality of life as indicated by the Perceived Stress Scale-14 (PSS-14), The Brunnsviken Brief Quality of Life Scale (BBQ), and The World Health Organization-Five Well-Being Index (WHO-5). In addition, participants experienced little to no difficulty in using the program and were mostly satisfied with the intervention's platform and the choice of content.ConclusionsThis is the first internet intervention study for informal caregivers in Lithuania. The results suggest that therapist-guided ICBT can be effective in reducing caregiver burden, anxiety, depression, stress, and improving quality of life.Trial registrationClinicalTrials.gov NCT04052724; https://clinicaltrials.gov/ct2/show/NCT04052724.

Project description:BackgroundPhysical activity is linked to benefits such as increased physical fitness, cognition, emotional and social functioning, general health and well-being in older people. Some evidence suggests that this also applies to people living with dementia. However, it can be harder for them to perform physical activities, due to several barriers, such as issues with orientation and balance problems. A relatively new type of physical activity called exergaming may help them overcome these barriers. Exergaming is "physical exercise interactively combined with cognitive stimulation in a gaming environment". The aim of our study is to evaluate the effectiveness and cost-effectiveness of exergaming compared to regular activities in people living with dementia, who attend day-care centres. Additionally, we want to investigate whether the exergaming activity for the person living with dementia, also (indirectly) affects the informal caregiver, as well as which facilitators and barriers to implementation of exergames for this target group exist.MethodsA cluster Randomized Controlled Trial (RCT), with economic and process evaluations alongside will be carried out. In the Netherlands, 24 day-care centres are randomized in the experimental or control group. The study group will consist of 224 dyads (community-dwelling participants with dementia and their informal caregivers), who are interviewed at baseline, and at 3 and 6 months of follow-up. The participant with dementia has to visit the day-care centre for at least two days per week, have a diagnosis of mild to moderate dementia and have an informal caregiver present, who is willing to participate. Societal cost data will be collected during interviews, using healthcare utilization diaries, and from day-care centres. The process evaluation will only involve the experimental group, and will include an online survey, qualitative interviews and focus groups.DiscussionThis study will contribute to the evidence base that more effective exercise among people with dementia will result in positive effects on their wellbeing and quality of life. This will motivate people with dementia to be physically active. We also envision that there might be a positive effect on the burden of care experienced by their informal caregivers.Trial registrationThis trial was registered at the Netherlands Trial Register (NTR) on December 10, 2015 (number: NTR5537 ), this publication is based on protocol amendment number 01, issue date 28 December 2018. This includes all items from the World Health Organization Trial Registration Data Set [see Additional file 1].

Project description:BACKGROUND:Across Europe, Canada, Australia, and the United States, the prevalence of home mechanical ventilation (HMV) prevalence is 6.6-12.9 per 100,000. At-home ventilator-assisted individuals (VAIs) are often vulnerable and highly comorbid, requiring complex care. In Canada, most VAI care is provided by family, leading to poor health-related quality of life and increased caregiver burden. No supportive interventions or peer support programs are tailored to VAI caregivers. Owing to the financial, geographic, and time limitations, Web-based support delivery may especially meet VAI family caregiver needs. We have developed a peer mentor training and Web-based peer support program for VAI caregivers including information-sharing, peer-to-peer communication, and peer mentorship. OBJECTIVE:Study Stage 1 aims to (1) evaluate the face and content validity of the peer mentor training program and (2) investigate participant satisfaction. Study Stage 2 aims to evaluate (1) the feasibility of participant recruitment and Web-based program delivery; (2) acceptability, usability, and satisfactoriness; (3) experiences of caregivers and peer mentors with the Web-based peer support program; and (4) effect of the Web-based peer support program on caregiver health outcomes. METHODS:Study Stage 1: We will train 7 caregivers to act as peer mentors for the Web-based peer support program trial; they will complete questionnaires rating the utility of individual training sessions and the training program overall. Study Stage 2: We will recruit 30 caregiver peers for a pilot randomized controlled trial of the 12-week Web-based peer support program using a waitlist control; the program includes private chat, a public discussion forum, and weekly moderated chats. Caregiver peers will be randomized to the intervention or waitlist control group using a 1:1 ratio using Randomize.net. Both groups will complete pre- and postintervention health outcome questionnaires (ie, caregiving impact, mastery, coping, personal gain, positive affect, and depression). Caregiver peers in the intervention arm will only complete a program evaluation and will be invited to participate in an interview to provide insight into their experience. Peer mentors will be invited to participate in a Web-based focus group to provide insight into their experience as mentors. We will judge the feasibility per the number of recruitment and program delivery goals met, use analysis of covariance to compare health outcomes between intervention and control groups, and analyze qualitative data thematically. RESULTS:Peer mentor training was completed with 5 caregivers in July 2018. To date, 2 caregivers have beta-tested the website, and the Web-based peer support program trial will commence in September 2018. Results are expected by early 2019. CONCLUSIONS:This study will result in the production and initial evaluation of a rigorously developed, evidence- and stakeholder-informed Web-based peer training and peer support program for caregivers of VAIs residing at home. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/11827.

Project description:BackgroundInformal caregivers (IC) of people with dementia (PwD) are at greater risk of developing physical and mental health problems when compared to the general population and to IC of people with other chronic diseases. Internet-based interventions have been explored for their potential to minimize the negative effects of caring, accounting for their ubiquitous nature, convenient delivery, potential scalability and presumed (cost) effectiveness. iSupport is a self-help online program developed by the World Health Organization (WHO) to provide education, skills training and support to IC of PwD. This paper describes the design of an intervention study aimed at determining the effectiveness of a Portuguese culturally adapted version of iSupport on mental health and other well-being outcomes.MethodsThe study follows an experimental parallel between-group design with two arms: access to the five modules and twenty-three lessons of "iSupport" for three months (intervention group); or access to an education-only e-book (comparison group). One hundred and eighty four participants will be recruited by referral from national associations. Inclusion criteria are: being 18 years or older and provide e-consent; being a self-reported non-paid caregiver for at least six months; of a person with a formal diagnosis of dementia; being skilled to use internet; and experience a clinically relevant level of burden (≥ 21 on Zarit Burden Interview) or depression or anxiety symptoms (≥ 8 on Hospital Anxiety and Depression Scale). Data is collected online, resorting to self-administered instruments, at baseline, 3 and 6 months after baseline. The primary outcome is caregiver burden, measured by the Zarit Burden Interview. Symptoms of depression and anxiety, quality of life, positive aspects of caregiving and general self-efficacy are secondary study outcomes. The data analysis will follow an Intention-to-treat (ITT) protocol.DiscussionThis protocol is an important resource for the many organizations in several countries aiming to replicate iSupport. Findings from this intervention study will offer evidence to bolster an informed decision making on scaling up iSupport as a new intervention program with minimal costs aimed at minimizing the psychological distress of IC of PwD in Portugal and elsewhere.Trial registrationClinicalTrials.gov, NCT04104568. Registered 26 September 2019.

Project description:SignificanceDue to caregiving commitments, caregivers of older adults may not have the time to make use of the onsite community services available to them during the day. With the support of advanced technology, telecare could be a convenient and easily accessible channel for providing individualized caregiving advice to caregivers.ObjectiveThe aim of the study is to describe a research protocol that highlights the development of a telecare-based intervention program for reducing stress levels in informal caregivers of community-dwelling older adults.MethodsIt is a randomized controlled trial. The study is supported by two community centers. The study participants will be randomly assigned to either the telecare-based intervention group or the control group. The former will receive a 3-month program comprised of three components: online nurse case management supported by a health and social care team, an online resource center, and a discussion forum. The latter will receive the usual services that provided by the community centers. Data will be collected at two time points - pre-intervention (T1) and post-intervention (T2). The primary outcome is stress levels, while secondary outcomes include self-efficacy, depression levels, quality of life, and caregiving burden.DiscussionBesides taking care of one or more older adults, informal caregivers have to deal with work, chores, and take care of their children. This study will add valuable information to the knowledge gap on whether telecare-based interventions with the support of an integrated health-social team can alleviate the stress levels of informal caregivers of community-dwelling older adults. If successful, policymakers and healthcare professionals should consider incorporating telecare modalities in a primary health setting for informal caregivers to correspond with them, to relieve their caregiving stress and promote a healthy life.Clinical trial registrationhttps://www.clinicaltrials.gov/, NCT05636982.

Dataset Information

Evaluating the efficacy of a web-based program (diapason) for informal caregivers of patients with Alzheimer's disease: protocol for a randomized clinical trial.

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Evaluating the efficacy of a web-based program (diapason) for informal caregivers of patients with Alzheimer's disease: protocol for a randomized clinical trial.

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