I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
NCT ID: NCT05733520
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2023-05-30
2027-07-30
Brief Summary
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Detailed Description
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The primary objective is to test the effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at 12 months. The investigators hypothesize that caregiver burden and patient BPSD will be lower among those participants randomized to the Brain CareNotes intervention compared to those randomized to the education-only attention control app at 12 months. The primary, powered outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI); the total NPI score measures patient BSPD and the caregiver distress sub-score measures caregiver burden. The investigators will obtain NPI responses from caregivers at baseline, six, and 12 months.
The secondary objective is to test the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at 12 months. The investigators hypothesize that participants randomized to the Brain CareNotes intervention will have lower caregiver depressive symptoms and decreased acute care utilization compared to those randomized to the control app. For caregiver depressive symptoms, investigators will use the researcher-administered Patient Health Questionnaire-9 (PHQ-9) at baseline, six, and 12 months. Acute care utilization data will be obtained from self-reports or Indiana's statewide Health Information Exchange (HIE), known as the Indiana Network for Patient Care (INPC), to identify both caregivers' and patients' hospital and ER visits that occurred within 12 months of enrollment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Brain CareNotes App
Brain CareNotes
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.
Attention Control App
Dementia Guide Expert
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."
Interventions
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Brain CareNotes
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
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."
Eligibility Criteria
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Inclusion Criteria
* Receiving primary care and
* Community-dwelling;
* English literate;
* Age ≥ 18 years
Exclusion Criteria
* Involvement in another clinical trial that would prevent or interfere with study objectives;
* Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Regenstrief Institute, Inc.
OTHER
Indiana University
OTHER
Responsible Party
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Richard Holden
Department Chair, Dean's Eminent Scholar & Professor
Principal Investigators
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Richard J Holden, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Malaz Boustani, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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IU Health
Indianapolis, Indiana, United States
Community Health Network
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Malaz Boustani, MD
Role: primary
Molly Campbell, DNP
Role: primary
Other Identifiers
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15749
Identifier Type: -
Identifier Source: org_study_id