I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT05733520
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Caregiver Burden
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Brain CareNotes — BEHAVIORALThe Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.
- Dementia Guide Expert — BEHAVIORALDementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."
Study Details
This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 39 months, the trial will enroll 184 caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.
Key Dates
- Start date
- May 30, 2023
- Status verified
- Nov 2025
- Primary completion
- Jul 30, 2027
- Completion
- Jul 30, 2027
Study Design
- Enrollment
- 184 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Brain CareNotes App
- Active Comparator: Attention Control App
Primary Outcome Measure
Caregiver Burden [ Time Frame: 12 months ]
Central Contacts
- Miriam J Rodriguez, PhD(812) 856-1661
- Jordan R Hill, PhD812-856-5032
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Community Health Network | Indianapolis | Indiana | 46203 | Molly Campbell, DNP |
| IU Health | Indianapolis | Indiana | 46202 | Malaz Boustani, MD |
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