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

ConditionMild Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • ACTIVE Intervention

    Behavioral

    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)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention, then ControlExperimental treatment 1 intervention
Group B: Control, then InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to Week 7 (End of Week 1 of Intervention Period)
2

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.

Time frame
Up to Week 8
3

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.

Time frame
Up to Week 8
4

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.

Time frame
Up to Week 8

Secondary outcomes

Other outcomes

Sponsors and contacts

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