Mobile Telehealth Intervention to Support Care Partners of Patients With Alzheimer Disease and Related Dementias (I-CARE 2): Protocol for a Randomized Effectiveness Clinical Trial

Abstract

Background: Nearly all individuals with Alzheimer disease and related dementias (ADRD) experience behavioral and psychological symptoms of dementia (BPSD), which include symptoms such as agitation, wandering, delusions, and hallucinations. Care partners (a person, often a family member, who provides care and support to someone with ADRD) struggle to manage BPSD, making symptom management a critical focus of intervention research. Our team has developed a mobile telehealth intervention (Brain CareNotes) to help care partners manage BPSD. Objective: This paper outlines a protocol for a randomized controlled trial of 160 care partners of patients with ADRD to test the effect of Brain CareNotes on care partner burden and patients' BPSD. Methods: Participants will be recruited from partner health systems in Indiana, United States, by word of mouth, and through community outreach efforts. They will be randomly assigned to use either the Brain CareNotes mobile app intervention-which helps care partners manage BPSD through the support of a care coach, written and visual materials on developing care skills, and BPSD measurement and tracking-or an education-only mobile app control for 12 months. Data will be collected over the phone at baseline, 6 months, and 12 months. Primary outcomes assessed for this trial are (1) care partner burden and (2) patients' BPSD. Secondary and exploratory outcomes assessed include care partner depressive symptoms, patient and care partner acute care use, intervention usability and acceptability, and intervention use. The trial will also collect patient and care partner demographics and measure care partner self-efficacy, care partner social support, patients' ADRD severity, and patients' functional abilities. Results: As of March 2025, we have enrolled 159 participants, and 42 have successfully completed the study. Conclusions: Brain CareNotes is a unique mobile app intervention to support care partners in managing BPSD. Due to the scalability of mobile health interventions, if Brain CareNotes is shown to be effective in reducing caregiver burden and patients' BPSD, it has the potential for widespread adoption to support many ADRD care partners.