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

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

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

Locations (2)

FacilityCityStateZIPSite coordinators
Community Health NetworkIndianapolisIndiana46203
Molly Campbell, DNP
IU HealthIndianapolisIndiana46202
Malaz Boustani, MD

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