Feasibility randomized controlled trial of a home-based support program for family caregivers of people with Alzheimer’s disease

Objective This study aimed to develop and preliminarily evaluate the feasibility of a home-based care program for family caregivers of individuals with Alzheimer’s disease (AD). Methods We developed a home-based intervention for AD caregivers through systematic literature review and two-round Delphi consensus (18 experts; authority coefficients 0.88–0.91). This feasibility randomized controlled trial enrolled 61 primary caregivers and assigned them to either an experimental group ( n=31 ) receiving a structured, evidence-based, 3-month home-care protocol, or a control group ( n=30 ) receiving conventional nursing guidance. Results The Delphi process achieved strong expert consensus. Post-intervention, caregivers in the intervention group demonstrated significant improvements in AD knowledge scores, anxiety reduction, and psychological domain QOL-AD scores compared to baseline ( P < 0.05). While total QOL-AD scores increased in the intervention group, between-group differences were not statistically significant. Conclusion The home-based care program proved feasible and effective in enhancing AD caregiver knowledge and mental health outcomes. These promising findings support the need for larger-scale efficacy trials to further validate clinical utility.