ACTIVE Intervention for Forgetfulness

(ACTIVE Trial)

Overseen By Oluwaseun Adeyemi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Dowin Boatright, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for pairs of older adults with forgetfulness and their care partners. Participants must be willing to use a Fitbit, receive text messages, watch educational videos, and participate in virtual physical therapy over 3 weeks.

Inclusion Criteria

Care Partners: Met criteria for survey participation

Care Partners: Person being cared for is recruited in the study

Care Partners: Willing to consent to participation

Exclusion Criteria

I have a severe condition that stops me from daily walking or using a Fitbit.

Care Partners: Pregnant care partners

Care Partners: Inability to operate or manage a Fitbit smartwatch device

What Are the Treatments Tested in This Trial?

Interventions

• ACTIVE Intervention

Trial Overview

The ACTIVE intervention being tested includes using a Fitbit smartwatch for activity tracking, receiving motivational texts for walking exercises, watching instructional videos, and attending virtual physical therapy sessions.

How Is the Trial Designed?

Group I: Intervention, then Control Experimental Treatment 1 Intervention

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).

Group II: Control, then Intervention Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+