ACTIVE Intervention for Forgetfulness

(ACTIVE Trial)

OA
Overseen ByOluwaseun Adeyemi, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help older adults with forgetfulness remain active. Participants will use a Fitbit smartwatch, receive motivational text messages, watch educational videos, and join virtual physical therapy sessions as part of the ACTIVE Intervention. The goal is to determine if these tools can improve memory and physical activity. It suits individuals aged 65 and up, with or without mild dementia, who can manage a Fitbit and are willing to participate in the activities. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for older adults.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical activity and using a Fitbit, so you may not need to change your medications, but it's best to check with the trial organizers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ACTIVE program, which includes a Fitbit smartwatch, motivational text messages, educational videos, and online physical therapy, is generally safe and easy to use. Studies have found that exercise and brain training can help prevent memory loss in older adults without causing major side effects. Health programs have used tools like Fitbits and digital resources, such as online therapy and educational videos, without major safety issues.

Although specific data on side effects for the ACTIVE program itself is limited, research supports the safety of its components. Participants often feel more motivated and engaged in physical activities, which are key elements of the program. Overall, the program appears safe for most people, benefiting both physical and mental health with minimal risk.12345

Why are researchers excited about this trial?

Researchers are excited about the ACTIVE Intervention for forgetfulness because it combines several innovative strategies: activity tracking, care partner participation, and virtual physical therapy, all supported by technology like Fitbit smartwatches. Unlike standard treatments that might rely solely on medication or traditional therapy, this approach uses a holistic mix of digital reminders and educational support to enhance memory and daily function. By integrating these elements, the ACTIVE Intervention aims to create a more engaging and personalized experience for participants, potentially leading to better adherence and outcomes.

What evidence suggests that this trial's treatments could be effective for forgetfulness?

Research shows that the ACTIVE program, provided to participants in this trial, can help maintain brain health. Studies suggest that exercise routines similar to those in ACTIVE might enhance brain function over time. Specifically, virtual physical therapy and educational videos aim to keep the mind sharp. Motivational text messages and Fitbit tracking, components of the ACTIVE intervention, encourage physical activity, which links to improved mental performance. Although data remains limited, early signs indicate this combined approach could benefit memory and thinking skills.46789

Who Is on the Research Team?

DB

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
See 8 more

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
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Pre-Intervention

Participants wear the Fitbit smartwatch during waking hours for baseline data collection and troubleshooting

1 week
Continuous monitoring

Intervention

Participants receive the ACTIVE intervention, including activity tracking, care partner co-participation, text reminders, instructional education, virtual physical therapy, and exercise

3 weeks
Continuous monitoring

Crossover/Washout

Participants switch arms from intervention to control or vice versa

1 week

Control

Participants continue in the control arm with Fitbit use only

3 weeks
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after the intervention

2 weeks

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?

2

Treatment groups

Experimental Treatment

Group I: Intervention, then ControlExperimental Treatment1 Intervention
Group II: Control, then InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

The ACTIVE Study: Study Overview and Major Findings - PMC

Results support the effectiveness of cognitive intervention in maintaining cognitive health over the long-term and indicate modest but detectable far transfer ...

A review of the effectiveness of memory interventions ...

The current paper reviews the evidence for the effectiveness of such interventions in enhancing learning of specific information, their impact on untrained ...

Effectiveness of exercise interventions to improve long ...

There is a trend that 6 + -month EXPA interventions improve global cognition 12 months after initiation. Evidence on long-term effects of EXPA ...

Effect of memory impairment on training outcomes in ACTIVE

Results indicated that memory-impaired participants failed to benefit from Memory training but did show normal training gains after reasoning and speed training ...

Evaluating the Effectiveness of Cognitive Interventions for ...

Extensive research indicates that cognitive interventions can lead to a general improvement in cognitive functioning throughout the lifespan ...

Memory support training and lifestyle modifications to ...

This paper describes the protocol of the Brain Boosters intervention, which synergistically combines training in compensatory and healthy lifestyle behaviors.

Cognitive interventions for memory and psychological well- ...

Here, we describe our recent research into Reminiscence Therapy (RT) to promote cognitive and psychological function in old age and early dementia.

The Impact of Physical Activity on Memory Loss and ...

The goal of this study is to outline the impact physical activity has on cognition and mental ability.

Lifestyle Physical Activity and Cognitive Training ...

Also called a data safety and monitoring board ... Physical activity interventions and cognitive training each prevent memory loss in healthy older adults.