Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise (ACTIVE)

Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise (ACTIVE) Intervention Among Older Adults With and Without Mild Dementia

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 Overview

• Status: Recruiting
• Conditions: Mild Dementia
• Intervention / Treatment: Behavioral: ACTIVE Intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oluwaseun Adeyemi, MD, PhD; Phone Number: 980-939-9764; Email: Oluwaseun.Adeyemi@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to Week 10
Intervention Delivery Fidelity	Proportion of intervention components successfully delivered by study staff.	Up to Week 8.
Participant Fidelity	Proportion of assigned intervention activities completed, verified via Fitbit logs, video analytics, and message tracking.	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.	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.	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.	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.	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.	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.	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.	Baseline, Up to Week 10

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Dowin Boatright, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-01158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Oluwaseun.Adeyemi@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Oluwaseun.Adeyemi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No