Mild DementiaACTIVENCT07321587
Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise
A study testing ACTIVE Intervention in people with Mild Dementia, run by NYU Langone Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Dementia
- What is being tested?
- ACTIVE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: 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.
- Conditions
- Mild Dementia
- Being tested
- ACTIVE Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVE InterventionBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention, then Control | Experimental | 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). Receives: Behavioral: ACTIVE Intervention |
| Control, then Intervention | Experimental | 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). Receives: Behavioral: ACTIVE Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 10
Intervention Delivery Fidelity
Proportion of intervention components successfully delivered by study staff.
Measured: Up to Week 8.
Participant Fidelity
Proportion of assigned intervention activities completed, verified via Fitbit logs, video analytics, and message tracking.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Up to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start26 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild DementiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dowin Boatright, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321587
- Sponsor's protocol ID
- 25-01158
- Acronym
- ACTIVE
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07321587
- Acronym / sponsor ID
- ACTIVE / 25-01158
- Conditions
- Mild Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention, then Control | Experimental | Behavioral: ACTIVE InterventionWeek 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). |
| Control, then Intervention | Experimental | Behavioral: ACTIVE InterventionWeek 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTIVE InterventionThe 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) | Behavioural | Control, then Intervention, Intervention, then Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dowin Boatright, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVE Intervention in people with Mild Dementia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oluwaseun Adeyemi, MD, PhD (980-939-9764, Oluwaseun.Adeyemi@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption (time frame: Up to Week 7 (End of Week 1 of Intervention Period)). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.