Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTIVE Intervention | Behavioral | The ACTIVE Intervention comprises the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Adoption | Measured as the proportion of participants who initiate use of each intervention component:
| 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:
| Up to Week 8 |
| Feasibility: Motivational Texts | Measured as sustained engagement with each component during the 3-week intervention:
| Up to Week 8 |
| Feasibility: Virtual Physical Therapy | Measured as sustained engagement with each component during the 3-week intervention:
|
Not provided
Not provided
Inclusion Criteria:
Older Adults:
Care Partners:
Exclusion Criteria:
Older Adults:
Care Partners:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oluwaseun Adeyemi, MD, PhD | Contact | 980-939-9764 | Oluwaseun.Adeyemi@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Dowin Boatright, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Up to Week 8 |
| Feasibility: Instructional Education Videos | Measured as sustained engagement with each component during the 3-week intervention:
| 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 |