Trial protocol published for app that structures family reports on dementia behavior symptoms

A peer reviewed protocol lays out a 160 person randomized trial testing whether a mobile app, Brain CareNotes, that structures what family care partners report about behavioral symptoms of Alzheimer's and related dementias eases caregiver burden and those symptoms. The trial is still enrolling; no effectiveness results exist yet.

Researchers at Indiana University have published the full protocol for I CARE 2, a randomized effectiveness trial testing Brain CareNotes, a mobile telehealth app built to help family care partners track and report behavioral and psychological symptoms of dementia (BPSD), such as agitation, wandering, delusions and hallucinations. The protocol, posted March 3, 2025 as a preprint and published September 3, 2025 in JMIR Research Protocols, describes a plan to recruit 160 care partners of people with Alzheimer's disease and related dementias (ADRD) from two health systems in Indiana, along with word of mouth and community outreach, and randomly assign them to 12 months of either the Brain CareNotes app or an education only control app. The app supports care partners through a remote care coach, written and visual materials on care skills, and a structured system for measuring and tracking BPSD, an approach the authors describe as building on earlier work from the Aging Brain Care clinic model.

The stated primary outcomes are care partner burden and patients' BPSD, measured by phone interview at baseline, six months and twelve months. Secondary and exploratory measures include care partner depressive symptoms, acute care use by both patient and care partner, and how usable and acceptable participants find the app. As of the March 2025 data cited in the paper, the trial had enrolled 159 of its planned 160 participants, with 42 having completed the full study protocol. Because this is a protocol paper, it reports study design and enrollment progress only; it contains no data on whether Brain CareNotes actually changes caregiver burden or symptom severity.

The authors frame the app's potential appeal as scalability: a mobile intervention that could, if shown effective, reach many more ADRD care partners than in person coaching programs typically can. That is a stated hypothesis, not a finding. The paper's own conceptual model, adapted from prior caregiver support research, anticipates reductions in burden and BPSD, but the randomized comparison needed to test that hypothesis is still running, with 12 month outcome data for the full cohort not yet available.

Families and clinicians watching this line of research will need to wait for the trial's completed outcome data, expected after the current 12 month follow-up periods conclude for all enrolled participants, before any claims about the app's effectiveness can be assessed.