New treatment option for Mild Dementia
Official title Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise
ClinicalTrials.gov ID: NCT07321587
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.