Effect of a home-based, dynamic, multidomain intervention on cognitive function in patients with cardiometabolic multimorbidity and their caregivers: The ‘LifeWise’ randomized controlled trial protocol

Background The globe has been promoting multi-domain interventions for dementia prevention in older adults. Multi-country cohort studies show that cardiometabolic multimorbidity (CMM) links to cognitive decline, but few multidomain interventions for CMM dyads have been developed. Objective To evaluate the LifeWise program's effectiveness in delaying cognitive decline and improving self-management in older patients with CMM and their caregivers. Methods 1220 patients with CMM aged 65 and older, with their caregivers, will be recruited from three hospitals in Tianjin, China. The dyads will be centrally randomized into intervention and control groups in a 1:1 allocation ratio. The LifeWise program includes a structured multidomain intervention (chronic condition management, cognitive enhancement, balanced nutrition, physical vitality, improved sleep, mental wellness, and social engagement) for the first 6 months, followed by continuously monitored and adjusted self-management behaviors based on ecological momentary assessment for up to 24 months. Primary and secondary outcomes will be assessed at baseline and at 6, 12, 18, and 24 months. Primary outcomes include global cognitive performance in CMM patients. Secondary outcomes include global cognitive performance in their caregivers, self-management, and the caregiver's contribution to self-management, cardiometabolic health (BMI < 24 kg/m², HbA1c < 7.0%/FPG < 7.0 mmol/L, blood pressure < 140/80 mmHg, and LDL cholesterol < 100 mg/dL or 2.6 mmol/L), nutrition, physical function, depression, social isolation, incident dementia, readmission and mortality, and neuroimaging metrics. Conclusions The LifeWise program will validate the effects of multi-domain interventions in CMM dyads. This study will provide evidence for integrating dementia prevention and dyadic disease management in the global chronic multimorbidity population.