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

NYU Langone Health

Status: Enrolling

Conditions: Mild Dementia

Treatments: Behavioral: ACTIVE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07321587

25-01158

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Intervention, then Control

Experimental group

Description:

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).

Treatment:

Behavioral: ACTIVE Intervention

Control, then Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: ACTIVE Intervention