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Recruiting NCT07321587

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

No phase Interventional Mild Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACTIVE Intervention.
Who it may be relevant to
Registry conditions: Mild Dementia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Adoption [Time frame: Up to Week 7 (End of Week 1 of Intervention Period)]
  • Feasibility: Smartwatch [Time frame: Up to Week 8]
  • Feasibility: Motivational Texts [Time frame: Up to Week 8]
  • Feasibility: Virtual Physical Therapy [Time frame: Up to Week 8]
  • Feasibility: Instructional Education Videos [Time frame: Up to Week 8]
  • Acceptability: System Usability Scale (SUS) [Time frame: Up to Week 10]
  • Acceptability: Perceived Usefulness (PU): Smartwatch [Time frame: Up to Week 10]
  • Acceptability: Perceived Usefulness (PU): Motivational Texts [Time frame: Up to Week 10]
  • Acceptability: Perceived Usefulness (PU): Instructional Education Videos [Time frame: Up to Week 10]
  • Acceptability: Perceived Usefulness (PU): Virtual Physical Therapy [Time frame: Up to Week 10]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07321587 · 25-01158

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗