Recruiting

ACTIVE Intervention

Sponsor:

NYU Langone Health

Code:

NCT07321587

Conditions

Mild Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ACTIVE Intervention

Study Details

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.

Conditions

Mild Dementia

Study ID

NCT07321587

Start date

Jan 26, 2026

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

ACTIVE Intervention

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)

Primary outcome measure

  • Adoption [ Time Frame: Up to Week 7 (End of Week 1 of Intervention Period) ]
  • Feasibility: Smartwatch [ Time Frame: Up to Week 8 ]
  • Feasibility: Motivational Texts [ Time Frame: Up to Week 8 ]
  • Feasibility: Virtual Physical Therapy [ Time Frame: Up to Week 8 ]
  • Feasibility: Instructional Education Videos [ Time Frame: Up to Week 8 ]
  • Acceptability: System Usability Scale (SUS) [ Time Frame: Up to Week 10 ]
  • Acceptability: Perceived Usefulness (PU): Smartwatch [ Time Frame: Up to Week 10 ]
  • Acceptability: Perceived Usefulness (PU): Motivational Texts [ Time Frame: Up to Week 10 ]
  • Acceptability: Perceived Usefulness (PU): Instructional Education Videos [ Time Frame: Up to Week 10 ]
  • Acceptability: Perceived Usefulness (PU): Virtual Physical Therapy [ Time Frame: Up to Week 10 ]
  • Acceptability: Perceived Ease-of-Use (PEU): Smartwatch [ Time Frame: Up to Week 10 ]
  • Acceptability: Perceived Ease-of-Use (PEU): Motivational Texts [ Time Frame: Up to Week 10 ]
  • Acceptability: Perceived Ease-of-Use (PEU): Instructional Education Videos [ Time Frame: Up to Week 10 ]
  • Acceptability: Perceived Ease-of-Use (PEU): Virtual Physical Therapy [ Time Frame: Up to Week 10 ]
  • Intervention Delivery Fidelity [ Time Frame: Up to Week 8. ]
  • Participant Fidelity [ Time Frame: Up to Week 8. ]
  • Change in Falls Efficacy Scale-International (FES-I) Score [ Time Frame: Baseline, Up to Week 10 ]
  • Change in Activities of Daily Living (ADL) Score [ Time Frame: Baseline, Up to Week 10 ]
  • Change in Instrumental Activities of Daily Living (IADL) Score [ Time Frame: Baseline, Up to Week 10 ]
  • Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Knowledge Score [ Time Frame: Baseline, Up to Week 10 ]
  • Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Attitude Score [ Time Frame: Baseline, Up to Week 10 ]
  • Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Attitude Score [ Time Frame: Baseline, Up to Week 10 ]
  • Change in Short Form - 12 Quality of Life Survey (SF-12) [ Time Frame: Baseline, Up to Week 10 ]

Central Contacts and Locations

Central contacts

Oluwaseun Adeyemi, MD, PhD

980-939-9764Oluwaseun.Adeyemi@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-01-28.