Abstract
BACKGROUND: Informal caregivers of home-dwelling people with dementia experience significant unmet needs. However, family physician teams as primary health care gatekeepers for aging populations in China remain an underused resource for structured caregiver support. OBJECTIVE: This hybrid effectiveness-implementation study aimed to evaluate a policy-aligned integration of the World Health Organization's iSupport web-based program with China's family physician contract services for informal dementia caregivers while systematically assessing implementation determinants using the Consolidated Framework for Implementation Research (CFIR). METHODS: A cluster randomized controlled trial enrolled 120 informal caregivers of people with dementia in Beijing randomly assigned to either the intervention group (n=60) receiving the family physician team-guided iSupport intervention plus usual care or the control group (n=60) receiving usual care plus only iSupport registration. Caregiver burden (primary outcome) and quality of life, social support, and learning behaviors (secondary outcomes) were assessed at baseline and the postintervention time point. Intention-to-treat analysis was applied. The quantitative data were analyzed using linear mixed models and generalized linear mixed models. Implementation barriers and facilitators were explored through CFIR-guided thematic analysis of semistructured interviews with 34 stakeholders. RESULTS: The intervention revealed no substantial between-group differences in caregiver burden (β=-3.80, 95% CI -11.25 to 3.65, P=.32), quality of life (β=-1.55, 95% CI -6.59 to 3.49, P=.55), or social support (β=0.85, 95% CI -2.86 to 4.56, P=.65). However, it demonstrated significantly improved learning behaviors in the intervention group (β=2.35, 95% CI 1.03-3.67; P<.001). CFIR analysis identified multilevel barriers: (1) policy-finance misalignment excluding dementia care from essential services, (2) digital adaptation gaps for older users, (3) lack of performance incentives in primary health care, (4) caregivers' technological and time constraints, and (5) conflicts between standardized content and personalized needs. CONCLUSIONS: This iSupport-based primary health care intervention presents a policy-aligned support model for dementia caregivers in China. While core outcomes showed no significant improvement, enhanced learning behaviors suggest potential for caregiver empowerment. Key implementation insights focused on optimizing digital platforms, strengthening policy incentives, and personalizing support. These findings offer a scalable, policy-aligned model for dementia care management by leveraging primary health care networks, particularly in low- and middle-income countries. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400084788; https://www.chictr.org.cn/showproj.html?proj=223091.