Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 3, 2025
Date Accepted: Jul 2, 2025
Mobile Telehealth Intervention to Support Care Partners of Patients with Alzheimer’s Disease and Related Dementias (I-CARE 2): Study Protocol for a Randomized Effectiveness Clinical Trial
ABSTRACT
Background:
Nearly all people with Alzheimer’s disease and related dementias (ADRD) will 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, and the management of these symptoms is a critical target for intervention research. Our team has developed a mobile telehealth intervention (Brain CareNotes) to help care partners manage BPSD through the support of a care coach, written and visual materials on developing care skills, and BPSD measurement and tracking.
Objective:
This article outlines a protocol for a randomized controlled trial of 160 care partners of patients with ADRD to test the effect Brain CareNotes on care partner burden and patient BPSD.
Methods:
Participants will be recruited from partner health systems in Indiana, via word-of-mouth, and through community outreach efforts. Participants will be randomly assigned to use either the Brain CareNotes mobile app intervention or an education-only mobile app control for 12 months. Data will be collected at baseline, 6-, and 12-months. Primary outcomes for this trial are 1) care partner burden, and 2) patient BPSD. Secondary and exploratory outcomes are care partner depressive symptoms, patient and care partner acute care utilization, intervention usability and acceptability, and intervention usage. The trial also collects patient and care partner demographics and measures care partner self-efficacy, care partner social support, patient ADRD severity and patient functional abilities.
Results:
I-CARE 2 was funded by the National Institute on Aging (1R01AG078234) in September 2022 and is funded through August 2027. As of March 2025, we have enrolled 159 participants and 42 have successfully completed the study.
Conclusions:
Brain CareNotes is a unique mobile 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 patient BPSD, it has the potential for widespread adoption to support many ADRD care partners. Clinical Trial: ClinicalTrials.gov NCT05733520; https://clinicaltrials.gov/study/NCT05733520
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