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NCT04621240 · ClinicalTrials.gov registry record · NA
The BrainHealth Project - Pilot Study
A NA study of Healthy, sponsored by The University of Texas at Dallas.
- Completed
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT04621240: Completed NA study of Healthy, sponsored by The University of Texas at Dallas.
NCT04621240 is a NA study of Healthy that has completed, run by The University of Texas at Dallas. The registered enrollment target is 180 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04621240, a NA study of Healthy, has completed, sponsored by The University of Texas at Dallas.
- COMPLETED
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed project is a pilot study in preparation for a larger study called The BrainHealth Project. The BrainHealth Project will be a prospective, longitudinal (10 yr) study focused on identifying determinants of brain health. Over the 4-month time commitment of this pilot study, 200 participants will complete online cognitive testing \& functional magnetic resonance imaging (fMRI) at 2 time points (pre- and post-intervention). Up to 200 participants will complete online cognitive testing at 2 time points (pre- and post-intervention) and no fMRI. In between those time points, all participants will participate in online training and education regarding ways to optimize brain health, as well as overall health. Online training that will be recommended to participants include the following: (1) Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance; and (2) Stress Solutions provides individuals with practical tools to reduce stress, build resilience and improve quality of life. The main objectives are: (i) to characterize lifestyle, cognitive, and behavioral markers related to an individual's cognitive function from adolescent to elderly ages, (ii) to assess the neural/biological determinants predictive of maintenance of brain health, and (iii) to evaluate the impact of available cognitive and lifestyle interventions on improving and maintaining brain health.
Primary Outcome
The BrainHealth Index is a composite score of 22 individual measures encompassing four components of brain health, including (1) cognitive performance, (2) mental well-being, (3) daily life functioning (e.g., sleep, fitness, activities), and (4) social interactions/engagement. \[Composite score min value = 30, Composite score max value = 82, higher composite score = better outcome\]
Conditions Studied
Interventions
- BEHAVIORAL Online SMART & Stress Solutions
Study Locations (1)
Texas
- UTD Center for BrainHealth - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2021-03-31 |
| Phase | NA |
What the finished NCT04621240 record still lists
NCT04621240 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Online SMART & Stress Solutions is the first listed.
NCT04621240 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04621240 about?
NCT04621240 is a clinical study titled "The BrainHealth Project - Pilot Study". The proposed project is a pilot study in preparation for a larger study called The BrainHealth Project. The BrainHealth Project will be a prospective, longitudinal (10 yr) study focused on identifying determinants of brain health. Over the 4-month time commitment of this pilot study, 200 participant...
What is the current status of trial NCT04621240?
This trial is currently completed. It is a NA study. The enrollment target is 180 participants. The study started on 2020-03-01. Estimated completion is 2021-03-31.
What conditions does trial NCT04621240 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04621240?
The interventions under investigation include: Online SMART & Stress Solutions (BEHAVIORAL).
Who is sponsoring clinical trial NCT04621240?
This trial is sponsored by The University of Texas at Dallas, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04621240 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04621240's enrollment target sits among peer trials
180 135th of 1090 higher than 953 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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