FAMILIA: Focused Adaptation of a Mobile Intervention for Dementia Caregivers
| Registry | NCT07792889, acronym FAMILIA |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 60 (Estimated) |
| Sponsor | Indiana University (Other); collaborators: National Institute on Aging (NIA) |
| Conditions | Caregiver Burden of People With Dementia |
| Interventions | Brain CareNotes Latino, Dementia Care app (Behavioral, other) |
| Dates | start 2027-03-01 (estimated), primary completion 2028-08-01 (estimated), completion 2028-08-01 (estimated), first posted 2026-08-28, last updated 2026-08-28 |
Related Papers Related Patents Related Grants Related Experts
All trials for Caregiver Burden of People With Dementia All trials of Brain CareNotes Latino All trials of Dementia Care app
The goal of this clinical trial is to evaluate usability, feasibility and preliminary efficacy of a mobile telehealth supported behavioral intervention for caregivers of persons with dementia who identify as Hispanic. The main question it aims to answer is: "is a mobile telehealth supported behavioral intervention aimed at supporting caregivers in managing behavioral and psychological symptoms of dementia (BPSD) usable and acceptable and can it preliminarily reduce depressive symptoms and caregiver burden after 6 months of exposure?
Hypothesis: The mobile/telehealth supported intervention will be feasible, as indicated by recruitment and retention rates, data completion, and usability and acceptance measures.
Exploratory Hypothesis: The mobile/telehealth supported intervention will improve caregiver burden and reduce BPSD as measured by the Neuropsychiatric Inventory (NPI-Q).
Researchers will compare an intervention group to a control group to see if there are differences in preliminary outcomes.
Participants will communicate with care coaches through the app and through individualized remotely delivered sessions. The app generates advice cards to develop a care plan that addresses behavioral and psychological symptoms of dementia (BPSD), and tracks cognitive, functional, behavioral and psychological symptoms of the patient and informal caregiver participant's health and quality of life. Individual care coach sessions will focus on management of BPSD and caregiver burden.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mobile/telehealth supported behavioral intervention | Experimental | Behavioral: Brain CareNotes Latino | This arm will include participants receiving the intervention |
| Control group | Placebo comparator | Other: Dementia Care app | Control groups will receive an information only app |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Self-identify as Hispanic/Latino and are informal caregivers of a person with dementia. 2. Able to speak or read English or Spanish 3. Able to use technology as measured by a technology screening measure. 4. Age 18 and older Exclusion Criteria: \- Caregivers of individuals with non-dementia related disease.
NIH grants: K23AG084856