Newswise — The National Institutes of Health's National Institute on Aging (NIA) recently awarded researchers from Indiana University's School of Public Health-Bloomington and School of Medicine $3.96 million to fund a five-year, randomized clinical trial of an Alzheimer’s disease and related dementia (ADRD) telehealth intervention. In part, the I-CARE 2 trial will measure the impact of Brain CareNotes, a specific mobile telehealth application, on informal caregivers of patients living with ADRD.
The I-CARE 2 randomized clinical trial follows I-CARE, a pilot study to establish the feasibility and potential efficacy of the Brain CareNotes app. (The mobile app is designed to help informal/family caregivers manage behavioral and psychological symptoms of dementia such as wandering, agitation, depression, and insomnia. It also remotely connects caregivers to trained "coaches".) After six months of use, the mobile app eased caregiver burden and reduced behavioral and psychological symptoms in the dementia patients for whom they cared.
"The I-CARE 2 trial will be nearly three times the size and a much broader study than the first one," co–principal investigator Dr. Richard Holden says. Holden, a dean’s eminent scholar and professor at the IU School of Public Health-Bloomington, is chair of the Department of Health & Wellness Design. He also serves as a research scientist with the Indiana University Center for Aging Research at the Regenstrief Institute. He continues, "This will be the definitive trial to tell us whether the app improves informal caregiver and patient health outcomes."
The randomized clinical trial will include participants from across the state of Indiana. "Our first trial had a sample that was over 40% African American and we intend to continue our efforts to enroll a diverse sample, including a larger proportion of Hispanic participants," Holden adds. "We are trying to change the current trend that clinical trials in ADRD underrepresent racial and ethnic minority groups. Our interventions should work for everyone."
Some trial endpoints will include caregiver burden and depressive symptoms, patient symptoms, and the rate of unplanned hospital visits and emergency admissions for both patients and informal caregivers. "We will test hypotheses that those outcomes are all lower at 12 months in the intervention group versus the control group," Holden says.
If those hypotheses bear out, there could be important implications for the cost of healthcare. "Our BrainCare Notes solution is built entirely for the purpose of scaling the evidence-based, collaborative care model for dementia," IU School of Medicine Professor and co–principal investigator Dr. Malaz Boustani says. "It's the most evidence-based model that is actually right now helping people living with dementia to reduce their behavioral/psychological symptoms and reduce—and even prevent—the stress and the burden of their informal caregivers."
"For the healthcare insurance and the payer, it saves a significant amount of money," Boustani continues. "In one of our studies, it saved close to $3,500 per member per year. The I-CARE 2 trial and Brain CareNotes are trying to scale this evidence-based collaborative care model, so that the only thing you need is Internet connectivity and the ability to interact with a community health-based worker via this telehealth mode of delivery."
"It is exciting to see technology being integrated into the caregiving experience in a way that is inclusive and has the potential to be of major assistance for informal caregivers," says Dr. Peter Lichtenberg, director of the Wayne State University Institute of Gerontology. "As the number of people in the U.S. living with Alzheimer's disease continues to grow, caregiver well-being is increasingly vital. Dr. Holden combines his technological expertise with his understanding of the challenges of caregiving."
Learn more about the IU School of Medicine at medicine.iu.edu. Information about SPH-B is available at go.iu.edu/48bx.
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