Activity Tracking and Exercise for Mild Dementia
This study is testing an intervention called ACTIVE, which uses a Fitbit smartwatch to track activity, involves a care partner, sends motivational text messages, provides educational videos, and includes virtual physical therapy and walking exercises. The goal is to see how well people adopt these activities and how practical it is to use the smartwatch and text messages. You might be able to join if you are 65 years or older, with or without mild dementia, and are willing to use a Fitbit, receive texts, watch videos, and participate in physical therapy and walking. The study is currently unclear on its recruitment status and plans to enroll 100 participants.
- Study design
- This is a randomized controlled trial with two groups, involving 50 pairs of older adults and their care partners. It is analyst-blinded, meaning the people analyzing the results won't know which group participants were in.
- What's involved
- You would receive the ACTIVE intervention components over 3 weeks. This involves wearing a Fitbit smartwatch, receiving text messages, watching videos, and participating in virtual physical therapy and walking exercise.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures adoption of the intervention up to Week 7 and feasibility of the smartwatch and motivational texts up to Week 8.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Dowin Boatright, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- AdoptionUp 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: SmartwatchUp 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 TextsUp 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 TherapyUp 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 VideosUp 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)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): SmartwatchUp 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 TextsUp 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 VideosUp 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 TherapyUp 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): SmartwatchUp 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 TextsUp 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 VideosUp 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 TherapyUp 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 FidelityUp to Week 8.
Proportion of intervention components successfully delivered by study staff.
- Participant FidelityUp 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) ScoreBaseline, 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) ScoreBaseline, 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) ScoreBaseline, 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 ScoreBaseline, 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 ScoreBaseline, 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 ScoreBaseline, 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)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.