A 2-year $427k NIH-funded trial led by co-PIs Holden and Boustani, testing the integration of the Brain CareNotes app into a coordinated dementia care program.

BRIEF PROJECT DESCRIPTION

I-CARE is an NIH funded randomized controlled trial (co-PIs Holden and Boustani) of integrating the Brain CareNotes application into a coordinated dementia care program. The trial tests Brain CareNotes, a mobile applications supporting caregivers of persons with Alzheimer's disease and related dementias. It is sponsored by the National Institute on Aging of the National Institutes of Health (NIA/NIH).

PROJECT ABSTRACT

Informal caregivers of patients with Alzheimer’s disease and related dementias (ADRD) manage a complex spectrum of patient behavioral and psychological symptoms of dementia (BPSD). BPSD are major contributing factors to caregivers’ burden and adverse health outcomes, leading to an increase of unplanned hospitalizations and a decrease in quality of life. The National Alzheimer’s Project Act recognizes the need for interventions that “enable family caregivers to continue to provide care while maintaining their own health and well-being.” Furthermore, recommendations from 2015 and 2018 Alzheimer’s Disease Research Summits include the application of technology to improve caregiving research and ADRD care.

Our team has translated decades of research on nonpharmachological interventions to manage patient BPSD and caregiver burden into a fully operational and self-sustaining clinical service called the Aging Brain Care (ABC) clinical program. However, our evaluations show that the ABC clinical program and other similar clinical services are limited by: 1) the number and availability of clinical providers; 2) incomplete or delayed BPSD and informal caregiver burden assessment data to inform timely clinical interventions; and 3) inadequate support for caregiver engagement in BPSD management and self-care.

To address these limitations, our research team developed a novel mobile health (mHealth) technology application called Brain CareNotes (BCN), which offers 24/7 support, assessment and longitudinal tracking of patient symptoms and caregiver burden, and engagement tools including a caregiver toolkit and secure bidirectional messaging with clinicians or trusted others.

We propose a pilot randomized controlled trial, named the I-CARE trial, in which we will test the feasibility and estimate the effect of BCN, as an add-on intervention to ABC, on caregiver burden and patient BPSD. We will enroll 60 patient-caregiver dyads over a period of 15 months and randomize each dyad into a BCN+ABC intervention group or an ABC alone control group. Data will be collected at baseline, 3, and 6 months in both groups. We will assess primary feasibility outcome measures of recruitment rate, data completion, and BCN usability, acceptance, and use as well as secondary outcomes of caregiver burden and patient BPSD. Means, standard deviations, and confidence intervals will be computed to test feasibility hypotheses. Mixed linear models will be used to test hypotheses comparing the two conditions at 6 months.

Informal caregiver burden and ADRD are both recognized as important public health problems.  Improving our understanding on how to care for patients with ADRD and their informal caregivers is urgently needed.