NCT07321587 Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise
| NCT ID | NCT07321587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Mild Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-01-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Dowin Boatright, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07321587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07321587 currently recruiting?
Yes, NCT07321587 is actively recruiting participants. Contact the research team at Oluwaseun.Adeyemi@nyulangone.org for enrollment information.
Where is the NCT07321587 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07321587 clinical trial?
NCT07321587 is sponsored by NYU Langone Health. The principal investigator is Dowin Boatright, MD at NYU Langone Health. The trial plans to enroll 100 participants.