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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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)
NYU Langone Health
New York, New York, United States
RECRUITINGAdoption
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.
Time frame: Up to Week 7 (End of Week 1 of Intervention Period)
Feasibility: Smartwatch
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.
Time frame: Up to Week 8
Feasibility: Motivational Texts
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.
Time frame: Up to Week 8
Feasibility: Virtual Physical Therapy
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.
Time frame: Up to Week 8
Feasibility: Instructional Education Videos
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.
Time frame: Up to Week 8
Acceptability: System Usability Scale (SUS)
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.
Time frame: Up to Week 10
Acceptability: Perceived Usefulness (PU): Smartwatch
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.
Time frame: Up to Week 10
Acceptability: Perceived Usefulness (PU): Motivational Texts
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.
Time frame: Up to Week 10
Acceptability: Perceived Usefulness (PU): Instructional Education Videos
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.
Time frame: Up to Week 10
Acceptability: Perceived Usefulness (PU): Virtual Physical Therapy
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.
Time frame: Up to Week 10
Acceptability: Perceived Ease-of-Use (PEU): Smartwatch
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.
Time frame: Up to Week 10
Acceptability: Perceived Ease-of-Use (PEU): Motivational Texts
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.
Time frame: Up to Week 10
Acceptability: Perceived Ease-of-Use (PEU): Instructional Education Videos
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.
Time frame: Up to Week 10
Acceptability: Perceived Ease-of-Use (PEU): Virtual Physical Therapy
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.
Time frame: Up to Week 10
Intervention Delivery Fidelity
Proportion of intervention components successfully delivered by study staff.
Time frame: Up to Week 8.
Participant Fidelity
Proportion of assigned intervention activities completed, verified via Fitbit logs, video analytics, and message tracking.
Time frame: Up to Week 8.
Change in Falls Efficacy Scale-International (FES-I) Score
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.
Time frame: Baseline, Up to Week 10
Change in Activities of Daily Living (ADL) Score
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.
Time frame: Baseline, Up to Week 10
Change in Instrumental Activities of Daily Living (IADL) Score
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.
Time frame: Baseline, Up to Week 10
Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Knowledge Score
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.
Time frame: Baseline, Up to Week 10
Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Attitude Score
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.
Time frame: Baseline, Up to Week 10
Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Attitude Score
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.
Time frame: Baseline, Up to Week 10
Change in Short Form - 12 Quality of Life Survey (SF-12)
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.
Time frame: Baseline, Up to Week 10
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