Abstract
BackgroundInformal 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.ObjectiveThe objective of our study was to assess the efficacy of a French Web-based psychoeducational program (called Diapason) with an unblinded randomized clinical trial.MethodsIn 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.ResultsThis 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.ConclusionsFindings 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 RegistrationClinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).
Highlights
TITLE 1a-i) Identify the mode of delivery in the title "Study protocol of a randomized clinical trial to evaluate the efficacy of a webbased program for informal caregivers of patients with Alzheimer’s disease: Diapason project". 1a-ii) Non-web-based components or important co-interventions in title
1a-iii) Primary condition or target group in the title Yes: "Study protocol of a randomized clinical trial to evaluate the efficacy of a webbased program for informal caregivers of patients with Alzheimer’s disease: Diapason project." ABSTRACT 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "Methods and designs: 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)
In the case of caregivers of patients with dementia, several websites exist in France, but these programs have not been, to our knowledge, subjected to a randomized clinical trial." METHODS 3a) CONSORT: Description of trial design including allocation ratio "The purpose of this article is to present the study protocol of a randomized clinical trial designed to evaluate the efficacy of Diapason, a web-based psychoeducational program for caregivers of patients with Alzheimer’s disease (AD)
Summary
1a-iii) Primary condition or target group in the title Yes: "Study protocol of a randomized clinical trial to evaluate the efficacy of a webbased program for informal caregivers of patients with Alzheimer’s disease: Diapason project." ABSTRACT 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "Methods and designs: 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). 'Face-to-face evaluations for both groups are planned every 3 months (M0 – M3 and M6)." "Assessing the efficacy of a French web-based psycho-educational program (called Diapason) with an unblinded randomized clinical trial was the aim of..." 1b-iv) RESULTS section in abstract must contain use data It is an ongoing protocol. 2a-ii) Scientific background, rationale: What is known about the (type of) system "There are many reasons for caregivers to use or to prefer a distance intervention instead of a face-to-face one.(...) some of them live in remote regions, and other CGs do not feel at ease with face-to-face interventions or prefer a flexible time/content intervention [7]."
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