NCT07321587 · NYU Langone Health
Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise
(ACTIVE)
What this study is about
This is a multi-methods two-treatment group$1, crossover, analyst-blinded randomly assigned controlled trial with embedded qualitative interviews, enrolling 50 dyads (older adult-care partner).
View original scientific description
This is a multi-methods two-arm, crossover, analyst-blinded randomized controlled trial with embedded qualitative interviews, enrolling 50 dyads (older adult-care partner). Participants will receive the ACTIVE intervention, which includes a Fitbit smartwatch, motivational text messages to engage in walking exercise, instructional educational videos, and virtual physical therapy sessions. Intervention components will be delivered over 3 weeks, with continuous monitoring of physical activity via Fitbit data, read receipts of the motivational text messages, and log of engagement in the virtual physical therapy and educational videos.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations