Effects of the mHealth Supportive Care Program for Family Caregivers of Individuals With Dementia and Diabetes: Pilot Randomized Controlled Trial.

Background: The comorbidity of dementia and type 2 diabetes mellitus exacerbates the burden on family caregivers (FCGs). Mobile health (mHealth) technology offers a promising alternative to overcome the spatiotemporal limitations of traditional interventions, but evidence for its efficacy in supporting dementia-type 2 diabetes mellitus caregivers remains scarce. Objective: This study aimed to evaluate the effectiveness of an mHealth supportive care program for FCGs of individuals with dementia and diabetes, focusing on caregiver burden, social support, and dementia care knowledge. Methods: A 2-arm, parallel-group randomized controlled trial was conducted. Between September 2022 and January 2023, FCGs were recruited from 5 urban and 10 rural communities under a community health center in Xiamen, China. Eligible caregivers were legally related to the patient, providing care for more than 8 hours per day for at least 1 month, conscious adults with basic literacy, owning and able to use a smartphone, and willing to provide informed consent. Their care recipients met diagnostic criteria for both dementia and type 2 diabetes, aged more than 60 years. Participants were randomly allocated (1:1) to intervention (n=30) or wait-list control (n=30). The intervention group received a 12-week mHealth supportive care program via the "Xiamen i-Health" platform, comprising 6 core modules (updated biweekly) and on-demand teleconsultation, in addition to conventional offline health education. The control group received conventional monthly 1-hour home-visit health education only. The primary outcome was caregiver burden measured by the Caregiver Burden Inventory (CBI). Secondary outcomes included social support (Social Support Rating Scale; SSRS) and dementia care knowledge (Dementia Care Knowledge Scale; DCKS). Assessments were performed at baseline (T0) and 3-month postintervention (T1). Only data collectors and statistical analysts were blinded. Results: Of 108 potential participants, 60 were randomly assigned. Per-protocol analysis included 55 participants (intervention group n=28 and control n=27). Postintervention, the intervention group showed a significantly greater reduction in CBI scores compared to the control group (between-group difference, Z=-3.534, P<.001, r=0.477). The intervention group also demonstrated significantly greater improvements in SSRS (Z=2.494, P=.01) and DCKS scores (Z=-4.233, P<.001, r=0.570). Subgroup analyses revealed that the reduction in caregiver burden was more pronounced among male, younger (60 y), physical labor, and lower-income caregivers. No intervention-related adverse events were reported. Conclusions: This theoretically grounded mHealth supportive care program effectively reduced burden and improved outcomes for FCGs managing dementia-diabetes comorbidity. The integrated online-offline delivery model shows particular promise for male, younger, manual labor, and lower-income caregivers, suggesting mHealth's potential to address health equity. These findings provide a feasible model for scalable caregiver support in resource-limited primary care settings. Future research should involve multicenter trials with longer follow-up and cost-effectiveness analyses.