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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brain CareNotes — BEHAVIORAL
    The 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 — BEHAVIORAL
    Dementia 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 App
    The 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 App
    Dementia 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

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University BloomingtonBloomingtonIndiana47405
Addison Harrington, BS
(317) 274-9228
Jordan R Hill, PhD (PRINCIPAL_INVESTIGATOR)
Richard J Holden, PhD (PRINCIPAL_INVESTIGATOR)

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