I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
I-CARE 2
I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Caregivers and Patients
2 other identifiers
interventional
184
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
November 24, 2025
November 1, 2025
4.2 years
February 8, 2023
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Caregiver Burden
The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score. The distress score is calculated by adding the distress score for each of the 12 items of the NPI. A score of 0 would indicate that the BPSD cause no distress while a score of 60 would indicate that each symptom causes severe distress for the caregiver.
12 months
Patient BPSD
Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI). The NPI is a 12-item questionnaire. The total score is calculated by adding the product of the frequency and severity of those 12 items. A score of 0 would indicate that no symptoms are present while a score of 144 would indicate that all symptoms are present at the highest level of frequency and severity.
12 months
Secondary Outcomes (3)
Caregiver Depressive Symptoms
12 months
Caregiver Acute Care Utilization
12 months
Patient Acute Care Utilization
12 months
Other Outcomes (5)
Caregiver Self-efficacy
12 months
Caregiver Social Support
12 months
System Usability Scale
12 months
- +2 more other outcomes
Study Arms (2)
Brain CareNotes App
EXPERIMENTALAttention Control App
ACTIVE COMPARATORInterventions
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 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
You may qualify if:
- Self-identified primary unpaid caregiver of a person diagnosed with ADRD (at any stage) who are:
- Receiving primary care and
- Community-dwelling;
- English literate;
- Age ≥ 18 years
You may not qualify if:
- Care recipient is a permanent resident of an extended care facility (nursing home);
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Institute on Aging (NIA)collaborator
- Regenstrief Institute, Inc.collaborator
Study Sites (2)
IU Health
Indianapolis, Indiana, 46202, United States
Community Health Network
Indianapolis, Indiana, 46203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard J Holden, PhD
Indiana University
- PRINCIPAL INVESTIGATOR
Malaz Boustani, MD
Indiana University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The primary investigator and outcome assessor will be masked to the App assignment (Brain CareNotes vs Attention Control App)
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department Chair, Dean's Eminent Scholar & Professor
Study Record Dates
First Submitted
February 8, 2023
First Posted
February 17, 2023
Study Start
May 30, 2023
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share