Feasibility and preliminary effectiveness of an online training and support program for caregivers of people with dementia in India: a randomized controlled trial.

OBJECTIVES: Internet-based interventions involving elements of cognitive behavior therapy, psychoeducation, relaxation and skills training for caregivers of people with dementia have been found to be promising in Western countries. Given these outcomes, the adapted version of a multi-component online caregiver skills training and support program of the World Health Organization, called iSupport, was tested for feasibility and preliminary effectiveness in India. METHODS: One hundred fifty-one caregivers of family members with a diagnosis of Alzheimer's disease or dementia were randomized to either the intervention arm (iSupport; n = 74) or to the control group (an education-only e-book program; n = 77). Participants were assessed using self-rated measures of depression and perceived burden, which were the primary outcome measures, at baseline and 3-month follow-up. Person-centered attitude, self-efficacy, mastery and self-rated health were also assessed. RESULTS: Fifty-five caregivers (29 in the iSupport group and 26 in the control condition) completed the study. The recruitment and retention rate of the study were 44.67% and 36.42% respectively. No significant differences were found between the two groups at 3-month follow-up on the primary outcomes. Among the secondary outcomes, significant improvement was only seen in caregivers' person-centered attitude towards persons with dementia in the iSupport group (t = 2.228; p < 0.05). CONCLUSIONS: Despite efforts to recruit and retain participants to the online program, this study had a low recruitment and retention rate, which require closer attention and indicates a need for further adaptations of the Indian version of the iSupport program to improve its acceptability and accessibility. The lessons learned from this study will guide the further development of caregiver training and support interventions in India. The trial was registered with the Clinical Trials Registry-India (Trial Registration No. CTRI/2017/02/007876).

iSupport, an online training and support program for caregivers of people with dementia: study protocol for a randomized controlled trial in India.

BACKGROUND: Dementia has a huge physical, psychological, social and economic impact upon caregivers, families and societies at large. There has been a growing impetus to utilize Internet interventions given the potential scalability, and presumed cost-effectiveness and accessibility. In this paper, we describe the design of a randomized controlled trial (RCT) aiming to study the impact of online self-help programs on caregivers of people with dementia in India. The experimental group will receive an interactive training and support program and the comparison group will receive an education-only e-book. It will be among the first online support intervention RCTs for a mental health condition in a lower-middle income country. METHODS AND DESIGN: Two hundred and eight participants are expected to be recruited via several strategies (email, Internet and social media, telephone and face-to-face) starting in the Bangalore region of India. The inclusion criteria for participation in the trial are: (1) being 18 years or older, (2) being a self-reported caregiver of a person with dementia, (3) self-report that a family member has a diagnosis of dementia (AD8 ≥ 2), and experience caregiver distress (≥ 4 on a 1-item burden scale ranging from 1 to 10 or ≥ 4 or < 20 on the Center for Epidemiologic Study-Depression (CES-D) scale (10-item) or ≥ 4 or < 15 on the Generalized Anxiety Disorder Scale (7-item). The intervention group will be offered iSupport, an online self-help training and support program, enabling a personalized education plan with a maximum of 23 lessons. These modules present a range of topics from "what is dementia?" to "dealing with challenging behaviors like aggression." The comparison group will receive an education-only e-book containing similar content. The outcomes of this trial are: caregiver burden as measured by the 22-item Zarit Burden Scale, depressive symptoms, anxiety symptoms (primary outcomes), quality of life, person-centered attitude, self-efficacy and mastery (secondary outcomes). DISCUSSION: Based on the findings of this trial, we will examine the potential use and scale up of iSupport for caregiver distress in India. This style of online self-help programs could be expanded to other regions or countries or to other suitable caregiver groups. TRIAL REGISTRATION: Clinical Trials Registry-India (CTRI), ID: CTRI/2017/02/007876 .