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

Victoria Cristancho-Lacroix, Hélène Kerhervé, Jocelyne de Rotrou, Alexandra Rouquette, Grégory Legouverneur, Anne-Sophie Rigaud, Victoria Cristancho-Lacroix, Hélène Kerhervé, Jocelyne de Rotrou, Alexandra Rouquette, Grégory Legouverneur, Anne-Sophie Rigaud

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; https://ichgcp.net/clinical-trials-registry/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).

Keywords: Alzheimer's disease; Internet; family caregivers; program effectiveness; psychoeducational program; psychological stress; randomized clinical trials.

Conflict of interest statement

Conflicts of Interest: None declared.

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