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

NCT ID: NCT07321587

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-26
• Study Completion Date: 2027-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

ACTIVE Intervention

Intervention Type: 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)

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).

Group Type: EXPERIMENTAL

ACTIVE Intervention

Intervention Type: 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)

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)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dowin Boatright, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Oluwaseun Adeyemi, MD, PhD

Role: CONTACT

Oluwaseun.Adeyemi@nyulangone.org

980-939-9764

Other Identifiers

25-01158

Identifier Type: -

Identifier Source: org_study_id