NCT07321587 · NYU Langone Health
Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise
(ACTIVE)
What this study is about
This is a multi-methods two-treatment group$1, crossover, analyst-blinded randomly assigned controlled trial with embedded qualitative interviews, enrolling 50 dyads (older adult-care partner).
View original scientific description
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.
Interventions
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)
Primary outcome measures
Adoption
Time frame: Up to Week 7 (End of Week 1 of Intervention Period)
Measured as the proportion of participants who initiate use of each intervention component: * Smartwatch: device activated and worn for ≥3 days during week 1. * Text reminders: ≥1 responses to text message opened/read in week 1. * Virtual PT videos: at least one session accessed in week 1, which will be tracked online through participant specific username. * Instructional education videos: at least one video accessed in week 1,which will be tracked online through participant specific username.
Feasibility: Smartwatch
Time frame: Up to Week 8
Measured as sustained engagement with each component during the 3-week intervention: * Smartwatch: proportion of days with ≥8 hours of wear time (captured on Fitabase). * Text reminders: proportion of responses to text messages (captured on Fitabase) opened or acknowledged. * Virtual PT videos: proportion of assigned sessions completed (captured on myACTIVEsteps.com via username); feasibility target. * Instructional education videos: proportion of assigned videos completed (captured on myACTIVEsteps.com via username.
Feasibility: Motivational Texts
Time frame: Up to Week 8
Measured as sustained engagement with each component during the 3-week intervention: * Text reminders: proportion of responses to text messages (captured on Fitabase) opened or acknowledged. * Virtual PT videos: proportion of assigned sessions completed (captured on myACTIVEsteps.com via username); feasibility target. * Instructional education videos: proportion of assigned videos completed (captured on myACTIVEsteps.com via username.
Feasibility: Virtual Physical Therapy
Time frame: Up to Week 8
Measured as sustained engagement with each component during the 3-week intervention: * Virtual PT videos: proportion of assigned sessions completed (captured on myACTIVEsteps.com via username); feasibility target. * Instructional education videos: proportion of assigned videos completed (captured on myACTIVEsteps.com via username.
Feasibility: Instructional Education Videos
Time frame: Up to Week 8
Measured as sustained engagement with each component during the 3-week intervention: * Instructional education videos: proportion of assigned videos completed (captured on myACTIVEsteps.com via username.
Acceptability: System Usability Scale (SUS)
Time frame: Up to Week 10
The SUS is a 10-item survey assessing the usability of a system. Each item is rated on a Likert scale from 1-5; the raw score is the sum of responses, which is transformed to a standardized score ranging from 0-100; higher scores indicate greater usability.
Acceptability: Perceived Usefulness (PU): Smartwatch
Time frame: Up to Week 10
The PU survey is a 5-item assessment of perceived usefulness of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived usefulness.
Acceptability: Perceived Usefulness (PU): Motivational Texts
Time frame: Up to Week 10
The PU survey is a 5-item assessment of perceived usefulness of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived usefulness.
Acceptability: Perceived Usefulness (PU): Instructional Education Videos
Time frame: Up to Week 10
The PU survey is a 5-item assessment of perceived usefulness of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived usefulness.
Acceptability: Perceived Usefulness (PU): Virtual Physical Therapy
Time frame: Up to Week 10
The PU survey is a 5-item assessment of perceived usefulness of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived usefulness.
Acceptability: Perceived Ease-of-Use (PEU): Smartwatch
Time frame: Up to Week 10
The PEU survey is a 5-item assessment of perceived ease-of-use of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived ease-of-use.
Acceptability: Perceived Ease-of-Use (PEU): Motivational Texts
Time frame: Up to Week 10
The PEU survey is a 5-item assessment of perceived ease-of-use of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived ease-of-use.
Acceptability: Perceived Ease-of-Use (PEU): Instructional Education Videos
Time frame: Up to Week 10
The PEU survey is a 5-item assessment of perceived ease-of-use of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived ease-of-use.
Acceptability: Perceived Ease-of-Use (PEU): Virtual Physical Therapy
Time frame: Up to Week 10
The PEU survey is a 5-item assessment of perceived ease-of-use of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived ease-of-use.
Intervention Delivery Fidelity
Time frame: Up to Week 8.
Proportion of intervention components successfully delivered by study staff.
Participant Fidelity
Time frame: Up to Week 8.
Proportion of assigned intervention activities completed, verified via Fitbit logs, video analytics, and message tracking.
Change in Falls Efficacy Scale-International (FES-I) Score
Time frame: Baseline, Up to Week 10
FESI-I is a 16-item self-report questionnaire assessing older adults' fear about falling during daily activities. Each item is rated on a Likert scale from 1-4 (not at all to very concerned). The total score is the sum of responses and ranges from 16-64, where higher scores mean more fear and less confidence.
Change in Activities of Daily Living (ADL) Score
Time frame: Baseline, Up to Week 10
The ADL ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Participants are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Change in Instrumental Activities of Daily Living (IADL) Score
Time frame: Baseline, Up to Week 10
IADL is an 8-item assessment of independence in completing complex tasks. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Knowledge Score
Time frame: Baseline, Up to Week 10
The Knowledge subsection of the KAP survey comprises 20 items assessing knowledge of physical exercise. Each item is rated on a Likert scale from 1-5. The total score is the sum of responses and ranges from 20-100; higher scores indicate greater knowledge.
Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Attitude Score
Time frame: Baseline, Up to Week 10
The Attitude subsection of the KAP survey comprises 10 items assessing attitude toward physical exercise. Each item is rated on a Likert scale from 1-5. The total score is the sum of responses and ranges from 10-50; higher scores indicate more positive attitude toward physical exercise.
Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Attitude Score
Time frame: Baseline, Up to Week 10
The Practice subsection of the KAP survey comprises 10 items assessing practice of physical exercise. Each item is rated on a Likert scale from 1-5. The total score is the sum of responses and ranges from 10-50; higher scores indicate greater practice of physical exercise.
Change in Short Form - 12 Quality of Life Survey (SF-12)
Time frame: Baseline, Up to Week 10
The SF-12 is a 12-item assessment of quality of life. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses; the raw score is converted to a standardized score ranging from 0-100 with a mean of 50 and standard deviation of 10. Higher scores indicate greater quality of life.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations