Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07321587
Status
Recruiting
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Conditions

  • Mild Dementia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ACTIVE Intervention — BEHAVIORAL
    The ACTIVE Intervention comprises the following components: * Fitbit Smartwatch-Based Activity Tracking * Care Partner Co-Participation * Motivational Text Messaging * Instructional Education Videos * Virtual Physical Therapy * Exercise (Walking Exercise)

Study Details

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.

Key Dates

Start date
Jan 26, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention, then Control
    Week 1 (Pre-Intervention): Participants will wear the Fitbit smartwatch during waking hours. Data collected during this week will serve as baseline and for troubleshooting technical issues. Weeks 2-4 (Intervention): Participants will receive the ACTIVE intervention (Activity tracking, Care partner co-participation, Text reminders, Instructional education, Virtual physical therapy and Exercise). Week 5 (Crossover/Washout): Participants will switch arms (intervention to control). Weeks 6-8 (Control): Participants will continue in the control arm (Fitbit use only).
  • Experimental: Control, then Intervention
    Week 1 (Pre-Control): Participants will wear the Fitbit smartwatch during waking hours. Data collected during this week will serve as baseline and for troubleshooting technical issues. Weeks 2-4 (Control): Participants will continue in the control arm (Fitbit use only). Week 5 (Crossover/Washout): Participants will switch arms (control to intervention). Weeks 6-8 (Intervention): Participants will the ACTIVE intervention (Activity tracking, Care partner co-participation, Text reminders, Instructional education, Virtual physical therapy and Exercise).

Primary Outcome Measure

Adoption [ Time Frame: Up to Week 7 (End of Week 1 of Intervention Period) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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