NCT05733520 I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
| NCT ID | NCT05733520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Caregiver Burden |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2023-05-30 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2023-05-30 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Richard J Holden, PhD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05733520 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Caregiver Burden. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05733520 currently recruiting?
Yes, NCT05733520 is actively recruiting participants. Contact the research team at mijrodri@iu.edu for enrollment information.
Where is the NCT05733520 trial being conducted?
This trial is being conducted at Indianapolis, United States, Indianapolis, United States.
Who is sponsoring the NCT05733520 clinical trial?
NCT05733520 is sponsored by Indiana University. The principal investigator is Richard J Holden, PhD at Indiana University. The trial plans to enroll 184 participants.