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

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

ArmDescriptionAssigned 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).
  • Behavioral: 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)
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).
  • Behavioral: 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)

Recruiting Locations

NYU Langone Health
New York 5128581, New York 5128638 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Oluwaseun Adeyemi, MD, PhD
980-939-9764
Oluwaseun.Adeyemi@nyulangone.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.