Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Feb 1, 2025
Date Accepted: Feb 12, 2026
Effects of the mHealth Supportive Care Program for Family Caregivers of Individuals with Dementia and Diabetes: Pilot Randomized Controlled Trial
ABSTRACT
Background:
Dementia care represents a critical global public health challenge, with traditional intervention models relying heavily on in-person or telephone-based formats. In China, where 70% of dementia patients depend on family caregivers (FCGs), the coexistence of dementia and type 2 diabetes mellitus (T2DM) exacerbates caregiver burden due to compounded cognitive and metabolic management demands. Existing interventions often overlook the multidimensional needs of FCGs, while resource constraints in primary healthcare systems limit the scalability of conventional offline programs. Mobile health (mHealth) technologies offer a promising alternative by overcoming spatial and temporal barriers, yet evidence for their efficacy in supporting dementia-T2DM caregivers remains scarce.
Objective:
This study aimed to evaluate the effectiveness of a mHealth supportive care program for FCGs of individuals with dementia and diabetes, focusing on caregiver burden, social support, and dementia care knowledge.
Methods:
This study employed a two-arm parallel-group randomized controlled trial design. Participants were randomized into intervention (n=30) and wait-list control groups (n=30). The control group received conventional offline health education during monthly 1-hour home visits, including standardized diabetes and dementia care education, with problem-solving for caregiver-raised issues. The intervention group received additional mHealth support through the "Xiamen i-Health" platform, comprising a 12-week program with 6 core modules (updated biweekly) and On-demand teleconsultation services. Both groups were assessed for caregiver burden (CBI), social support (SSRS), and knowledge of dementia care (DCKS) at baseline (T0) and 3-month post-intervention (T1).
Results:
Among the 60 participants, 55 completed the questionnaires at T1 (25 [45.45%] males and 30 [54.55%] females). At T1, the intervention group showed greater improvement compared to the control group in the CBI ( between-group difference, Z = -3.534, P <.001). Additionally, the intervention group showed significant improvement in CBI pre- and post-intervention (t = 8.574, P <.001). The three-way interaction analyses revealed that there are no significant moderating effects of demographic variables on SSRS and DCKS score changes. Analyses of third-order interaction effects on changes in CBI scores showed significant third-order interactions for time, subgroup, and gender. Subgroup analyses revealed stronger CBI improvements among male caregivers (P=.012), those aged <60 (P=.007), physical laborers (P=.021), and lower-monthly family income participants (P=.029).
Conclusions:
The mHealth program effectively enhanced social support and care knowledge among FCGs of individuals with dementia and diabetes, with reductions in caregiver burden being more pronounced among male, younger, manual labor, and lower-monthly family income caregivers. Its success underscores the value of integrating structured digital education with community health resources. Future research should address limitations including single-site sampling and short follow-up, while exploring cost-effectiveness and long-term outcomes. Clinical Trial: Registered at ClinicalTrials.gov (NCT06785857).
Citation
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Copyright
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