Effectiveness of web-based intervention for life-change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: A cluster-randomized controlled trial

Objective To test the effectiveness of the web-based intervention “Koji-family.net 3-day program” (KF3 PGM) for life-change adaptation in family caregivers of community-dwelling individuals with acquired brain injury (ABI). Design A cluster-randomized trial. Settings All 82 institutions for families of individuals with ABI in Japan. Participants Participants were 240 families at 16 different institutions for families of individuals with ABI. Inclusion criteria for participants were (1) families caring for an individual with ABI, (2) family members aged 20 years and over, and (3) the individual with ABI developed ABI when aged more than 16 years and less than 65 years. Methods Clusters were randomly assigned to the intervention (8 clusters, n = 120) or the control (8 clusters, n = 120) group. For the intervention group, the KF3 PGM was assigned, in addition to routine family group activities to enhance the life-change adaptation. The control group followed their daily routine and received usual services. The primary outcome was the life-change adaptation scale (LCAS); secondary outcomes were the multidimensional scale of perceived social support (MSPSS) and the positive appraisal of care (PAC) scale at the baseline, after 3 days (short-term follow-up), and after 1 month (long-term follow-up). A mixed model for repeated measures (MMRM) was applied. Results A total of 91 participants were enrolled. The mean age (SE) of the participants was 64.0 (9.2) years; 87.8% of them were female. The intervention group showed better improvement in the LCAS than the control group in the whole study period ( F = 6.5, p = 0.002). The mean observed change in LCAS from baseline was +8.0 (SE = 2.0) at 3 days and +11.6 (SE = 2.0) at 1 month in the intervention group ( F = 18.7, p < 0.001). No significant differences in MSPSS and PAC were observed among the intervention and control groups in the whole study. Conclusions The KF3 PGM can be an effective method of enhancing the adaptation to daily life in family caregivers of community-dwelling individuals with ABI. The results show that a potential web-based intervention in institutions for families of individuals with ABI plays a substantial, longer-term role in their support in Japan. Future studies could address the same research questions in different settings and cultures for family caregivers for even longer time periods.