Caring for Caregivers of Individuals With Alzheimer's Disease

May 6, 2026 updated by: Navin Kaushal, Indiana University

Caring for Caregivers of Individuals With Alzheimer's Disease- Promoting Virtual Home-based Exercise for Caregiver Wellbeing

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? Caring for a loved one with ADRD is demanding and is strongly linked to depression and anxiety. Regular exercise is one of the most effective ways to reduce these symptoms - but caregivers often cannot leave home to exercise due to the needs of their loved one, transportation concerns, and safety issues.

What does participation involve? Participants will be randomly assigned (like a coin flip) to one of two groups:

  • EMBRACE group: 24 weekly virtual group exercise sessions over 3 months (about 1 hour each), using an at-home elliptical device provided by the study. Months 4-6 include weekly check-in calls to support independent exercise. Educational sessions on habit-building and goal-setting are included.
  • Wait-list control group: Completes the same surveys and measurements; receives the program after data collection ends.

Who can join? Adults (18+) who are the primary unpaid caregiver for someone with ADRD, can read and speak English, and are healthy enough to exercise. Participants do not need to leave home - everything is virtual.

What is being measured? Exercise time (using a wearable device), symptoms of depression and anxiety, and whether the program is feasible and acceptable to participants.

Where is the study based? Indiana University Indianapolis. The study is conducted entirely virtually and remotely.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 significantly elevated rates of anxiety and depression compared to non-caregivers. Depression is the leading cause of disability worldwide, making the mental health of caregivers a critical public health concern.

Regular physical exercise is one of the most evidence-based strategies for preventing and alleviating depression and anxiety. However, rates of physical activity remain low nationwide, and research has shown that caregivers struggle to maintain exercise routines outside of controlled settings. Caregivers face unique barriers including the inability to leave their care recipient unattended, transportation burden, and unpredictable schedules. Home-based and virtual exercise programs have been identified as viable alternatives that bypass these barriers.

Study Purpose

The purpose of this Phase I randomized controlled trial is to test the feasibility, acceptability, and preliminary efficacy of the EMBRACE intervention - a theory-informed, home-based, virtual group exercise program tailored for family caregivers of individuals with ADRD.

Theoretical Framework

The EMBRACE intervention is grounded in Self-Determination Theory (SDT), which holds that sustained behavior change requires support for three basic psychological needs: autonomy (choosing when and how to exercise), competence (developing skills and knowledge), and relatedness (social connection with peers). The intervention further incorporates self-regulation strategies (goal-setting and planning) and habit formation principles to promote long-term independent exercise beyond the structured program period.

Intervention Structure

The EMBRACE program is delivered over 6 months in two phases:

Months 1-3 (Structured Phase): 24 weekly virtual group exercise sessions (~1 hour each), delivered in small groups of 6-7 participants across two daily time slots (morning and evening). Sessions follow a fixed structure: warm-up (5 min), cardiovascular exercise using a provided Cubii Total Body Elliptical (25 min), strength training (25 min), and cool-down (5 min). The first three sessions include theory-informed education modules on physical activity guidelines, habit formation, and exercise planning and goal-setting.

Months 4-6 (Independent Exercise Phase): Participants exercise independently, supported by weekly booster phone calls (5-10 min each) and weekly text message prompts functioning as behavioral habit cues.

Month 7: Exit focus groups are conducted to gather qualitative feedback on intervention facilitators and barriers.

All study equipment including a tablet, elliptical device, and accelerometer - is mailed to participants, enabling full remote participation.

Control Arm

Participants in the wait-list control arm complete all outcome measures at the same three time points as the intervention arm. The wait-list design is standard practice in behavioral trials involving caregivers and ensures participants eventually receive the program, which is ethically important given the established benefits of exercise for caregiver mental health.

Recruitment

Participants will be recruited through community-based advertising (churches, community centers) and patient referrals from the study's co-investigator geriatric psychiatrist. The study leverages an established community network developed through a related R24 project, including 12 local community leaders and over 300 newsletter recipients in Marion and Lake counties, Indiana.

Randomization and Blinding

Following baseline data collection, participants are randomized 1:1 to the EMBRACE or wait-list control arm. Data collectors administering outcome measures at all time points are blinded to group assignment.

Intervention Fidelity

Fidelity is maintained through standardized staff training, session recording with random fidelity checks using a structured quality assurance form, attendance tracking, and participant self-report exercise logs submitted via voice message.

Assistive Technology Component

To help caregivers carve out protected exercise time at home, the study incorporates multi-sensory assistive technologies designed to reduce disruptive or neuropsychiatric behaviors in individuals with dementia, thereby enabling caregivers to prioritize their own well-being during exercise sessions.

Future Directions

Findings from this Phase I trial will be used to refine the intervention and inform a Phase II efficacy trial. The investigators will also explore the feasibility of developing a concurrent caregiver-care recipient program.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Navin Kaushal, PhD, FACM,FAHA
  • Phone Number: 317 278-9598
  • Email: nkaushal@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46240
        • Recruiting
        • School of Health and Human Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: 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 formation, goal-setting, and self-regulation is embedded in the first three sessions to support long-term independent exercise adherence.
Behavioral: Exercise
Participants will engage in home-based exercise
No Intervention: No 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 completion of their data collection period, wait-list participants will be offered the full EMBRACE program as an ethical provision given the established benefits of exercise for caregiver mental health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 6 months
Physical activity will be measured by using Actigraph GT3X acclerometers. Specfically the average weekly moderate-to-vigorus physical activity (MVPA) time over the span of two weeks will be the primary outcome and analyzed.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protect participants confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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