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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Oluwaseun.Adeyemi@nyulangone.org
• Phone: 980-939-9764

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.