Mobile app to help caregivers of Alzheimer's patients
I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Caregivers and Patients
This study is testing a mobile app designed to help caregivers of Alzheimer's patients see if it can make their lives easier and improve the patients' symptoms over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT05733520 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Brain CareNotes mobile health application in reducing caregiver burden and behavioral and psychological symptoms of dementia in patients with Alzheimer's disease. Over 39 months, 160 unpaid caregivers will be randomized to use either the Brain CareNotes app or an education-only control app for 12 months. The primary outcomes will measure caregiver-reported symptoms and distress using the Neuropsychiatric Inventory at baseline, six, and twelve months. Secondary outcomes will assess caregiver depressive symptoms and acute care utilization.
Who should consider this trial
Good fit: Ideal candidates are unpaid primary caregivers of community-dwelling individuals diagnosed with Alzheimer's disease or related dementias.
Not a fit: Patients who are permanent residents of extended care facilities or those with impairments preventing mobile device use may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly alleviate the burden on caregivers and improve the quality of life for both caregivers and patients.
How similar studies have performed: Other studies have shown promise in using mobile health applications to support caregivers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Caregiver Inclusion Criteria: * 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 Caregiver Exclusion Criteria: * 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)
Where this trial is running
Indianapolis, Indiana and 1 other locations
- IU Health — Indianapolis, Indiana, United States (Recruiting)
- Community Health Network — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Richard J Holden, PhD — Indiana University
- Study coordinator: Miriam J Rodriguez, PhD
- Email: mijrodri@iu.edu
- Phone: (812) 856-1661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.