I-CARE Rural Pilot: Intervention for Rural-Dwelling Dementia Caregivers
Part of paid clinical trials in Bloomington, Indiana.
- Sponsor
- Richard Holden
- Study ID
- NCT07054385
- 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
The purpose of this study is to assess feasibility and to estimate efficacy of our app "Brain CareNotes" for dementia caregivers who reside in a rural setting (as defined by RUCA codes 4 through 10). The Brain CareNotes app is designed to reduce informal caregiver burden of those caring for individuals with Alzheimer's disease and related dementias (ADRD) and behavioral and psychological symptoms of dementia (BPSD) of individuals with ADRD. The study will enroll up to 60 rural caregivers of community-dwelling individuals living with ADRD. Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for six months, with usage reminders.
Key Dates
- Start date
- Jul 1, 2025
- Status verified
- Jun 2025
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Brain CareNotes AppThe 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.
- Active Comparator: Attention Control AppDementia 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."
Primary Outcome Measure
App Usability [ Time Frame: Six Months ]
Central Contacts
- Jordan R Hill, PhD(812) 856-5032
- Richard J Holden, PhD(317) 278-5323
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University Bloomington | Bloomington | Indiana | 47405 | Jordan R Hill, PhD (PRINCIPAL_INVESTIGATOR) Richard J Holden, PhD (PRINCIPAL_INVESTIGATOR) |
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