The testing will measure the effect of the app on caregivers of patients with dementia.
Researchers from the University of Indiana's School of Public Health-Bloomington and School of Medicine were recently awarded $3.96 million by the National Institutes of Health's National Institute on Aging. The award will fund a five-year clinical trial of a telehealth application for Alzheimer's and related dementias (ADRD).
Specifically, the I-CARE 2 trial will be measuring the effect of the Brain CareNotes telehealth app on caregivers of patients living with ADRD. The new trial is a follow-up of a pilot study on the efficacy of the app, which is designed to help informal and family caregivers manage the behavioral and psychological symptoms of dementia in patients and offer support by connecting caregivers to coaches.
The results of the trial could potentially bring applications like these into the hands of more family caregivers, enabling them to collaborate with providers to ensure quality and precise care for their loved one.
"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, a professor at the IU School of Public Health-Bloomington, said in a statement. "This will be the definitive trial to tell us whether the app improves informal caregiver and patient health outcomes."
Participants for the trial will come from Indiana, with Holden adding that researchers intend to have a diverse sample set. The previous trial, I-CARE, had a sample group that was over 40% African American, and in the I-CARE 2 trial, they hope to enroll a larger portion of Hispanic participants.
"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," Holden said.
Endpoints the I-CARE 2 trial will explore are caregiver burden and depressive symptoms, patient symptoms, and the rate of hospital visits and emergency admissions for both parties. The starting hypothesis, Holden explained, is the likelihood of those outcomes being lower after 12 months of using the Brain CareNotes app.
"Our Brain CareNotes solution is built entirely for the purpose of scaling the evidence-based, collaborative care model for dementia," Dr. Malaz Boustani , co-principal investigator for the study and professor at IU School of Medicine, said in a statement.
"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."
“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.”
Dr. Richard Holden, professor, IU School of Public Health-Bloomington
Jasmyne Ray is the revenue cycle editor at HealthLeaders.
KEY TAKEAWAYS
The award will be used to fund a five-year clinical trial of a telehealth application for informal caregivers of patients with Alzheimer's or related dementias.
The hypothesis for the study is that caregivers will have reduced behavioral and psychological symptoms after using the app for 12 months.
The group of researchers behind the trial are intentionally taking efforts to have a sample set with caregivers and patients from diverse backgrounds.