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Clinical Trial NCT07486037 for Intervention Group, Treatment as Usual is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Caring for Caregivers 25 Home-Based At-Home Transport Provided Wearable Device
Clinical Trial NCT07486037 is an interventional study for Intervention Group, Treatment as Usual that is recruiting. It started on March 1, 2026 with plans to enroll 25 participants. Led by Indiana University, it is expected to complete by June 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 20, 2026.
Brief Summary
What is this study about? This study is called the EMBRACE Study - A Virtual Community Empowerment Approach Integrating Tradition and Technology for Family Caregivers of Individuals with Alzheimer's Disease. It tests whether a home-based virtual exercise program can reduce depression and anxiety in family caregivers of people living with Alzheimer's disease and related dementias (ADRD).
Why is this study needed? Car...
Show MoreDetailed Description
Background and Rationale
As the U.S. population ages, the number of individuals living with Alzheimer's disease and related dementias (ADRD) is growing substantially. Family caregivers of adults with ADRD perform complex daily tasks, including activities of daily living, financial management, and medication management, yet are frequently unprepared for the scope of the role. ADRD caregiving is associated with signif...
Show MoreOfficial Title
Caring for Caregivers- Promoting Virtual Home-based Exercise for Caregiver Wellbeing
Conditions
Intervention GroupTreatment as UsualOther Study IDs
- 29378
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-03-20
Completion Date (Estimated)
2028-06-01
Enrollment (Estimated)
25
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExperimental: EMBRACE Virtual Home-Based Exercise Participants in the EMBRACE arm will receive a 6-month home-based virtual exercise program consisting of 24 weekly group exercise sessions (months 1-3) followed by a supported independent exercise phase (months 4-6). All equipment, including a Cubii Total Body Elliptical and tablet, will be mailed to participants so the program can be completed entirely from home. Theory-informed educational content on habit formatio...Show More | Exercise Participants will engage in home-based exercise |
No InterventionNo Intervention: Wait-List Control Participants in the wait-list control arm will complete all study outcome measures at the same three time points as the experimental arm (baseline, month 3, and month 6) but will not receive the EMBRACE intervention during the data collection period. This treatment-as-usual approach is standard practice in behavioral trials involving caregivers and allows for a clean comparison of outcomes between groups. Upon comple...Show More | N/A |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Physical Activity | Physical activity will be measured by using Actigraph GT3X acclerometers. | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Self-identifies as African American
- Age 18 years or older
- Primary unpaid caregiver for an adult living with Alzheimer's disease or a related dementia (ADRD)
- Able to read and speak English
- Deemed sufficiently healthy to participate in exercise per the PAR-Q+ screening questionnaire
- Has access to an email address
- Diagnosed psychiatric illness
- Untreated severe major depression
- Currently receiving advanced cancer treatment or hospice care
- Currently receiving dialysis
- Severe hearing loss without hearing aids
- Severe vision impairment without corrective eyeglasses
- No access to a phone or email
- Unable to safely exercise based on PAR-Q+ screening
- Already meeting the recommended physical activity guidelines at the time of enrollment
Study Responsible Party
Navin Kaushal, Principal Investigator, Associate Professor, Indiana University
Study Central Contact
Contact: Navin Kaushal, PhD, FACM,FAHA, 317 278-9598, [email protected]
1 Study Locations in 1 Countries
Indiana
School of Health and Human Sciences, Indianapolis, Indiana, 46240, United States
Navin Kaushal, PhD, Contact, 317-450-5240, [email protected]
Recruiting