Fitbit-supported walking program with care partner coaching, text reminders, videos, and virtual physical therapy for older adults with mild dementia

Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise (ACTIVE) Intervention Among Older Adults With and Without Mild Dementia

This program will try a Fitbit-based approach with text reminders, instructional videos, and virtual physical therapy alongside a care partner to see if it helps older adults with mild dementia walk more and stay active.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07321587 on ClinicalTrials.gov

What this trial studies

This is a two-arm, crossover, analyst-blinded randomized controlled trial enrolling 50 older adult–care partner dyads to deliver a multicomponent intervention called ACTIVE. Participants receive a Fitbit smartwatch, motivational text messages, instructional educational videos, and virtual physical therapy sessions delivered over three-week intervention periods, with continuous monitoring of activity and engagement. The study captures Fitbit activity data, text message read receipts, and logs of video and physical therapy participation, and includes embedded qualitative interviews to explore participant and care partner experiences. The crossover design allows each dyad to serve as its own control while analysts remain blinded to allocation during outcome analysis.

Who should consider this trial

Good fit: Ideal candidates are community-dwelling older adults aged 65 or older with or without mild dementia who have a willing care partner (age 18+), can safely engage in walking exercise, and are willing to use a Fitbit, receive text messages, watch videos, and join virtual physical therapy.

Not a fit: Patients with severe cardiac, neurologic, or musculoskeletal conditions that limit participation, those unable or unwilling to use wearable or phone-based technology, or those without an available care partner are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the intervention could increase daily walking and overall physical activity, improve engagement with exercise, and support care partners in promoting mobility.

How similar studies have performed: Previous studies have shown that wearables, reminders, and caregiver-supported programs can increase activity in older adults, but combining these elements in a short, crossover intervention for people with mild dementia is relatively novel.

Eligibility criteria

Inclusion Criteria:

Older Adults:

* Age ≥65 years.
* With or without mild dementia.
* Willing to consent to participate in the study or have an LAR that is willing to consent for their participation in the study
* Willing to wear a Fitbit smartwatch, receive text messages, watch intervention-related videos, participate in physical therapy, and walking exercise.
* No contraindications to engaging in physical activity.

Care Partners:

* Age ≥18 years.
* Met criteria for survey participation.
* Person being cared for is recruited in the study.
* Willing to consent to participation
* Willing to wear a Fitbit smartwatch, receive text messages, watch intervention-related videos, participate in physical therapy, and walking exercise.
* No contraindications to engaging in physical activity.

Exclusion Criteria:

Older Adults:

* Severe cardiac, neurologic, or musculoskeletal condition (including but not limited to recent or untreated fracture in any part of the body)
* limiting participation in daily walking or Fitbit smartwatch use.
* Moderate to severe dementia (using the clinical dementia rating scale of 2 or higher
* Inability to operate or manage a Fitbit smartwatch device (even with care partner support).
* No phone or phone not capable of receiving text messages or watching videos.
* No internet for watching videos

Care Partners:

* Severe cardiac, neurologic, or musculoskeletal condition limiting participation in daily walking or Fitbit smartwatch use.
* Pregnant care partners
* Any level of dementia or cognitive impairment among care partners
* Inability to operate or manage a Fitbit smartwatch device.
* Inability to co-participate in intervention tasks with older adult
* No phone or phone not capable of receiving text messages or watching videos.
* No internet for watching videos

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Dowin Boatright, MD — NYU Langone Health
• Study coordinator: Oluwaseun Adeyemi, MD, PhD

Conditions Mild Dementia