Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise
Purpose
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.
Condition
- Mild Dementia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
New York 5128581, New York 5128638 10016
More Details
- Status
- Recruiting
- Sponsor
- NYU Langone Health