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NCT04309864 · ClinicalTrials.gov registry record · NA
CMAP Refinement for Pressure Injury Prevention
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT04309864: Completed NA study, sponsored by VA Office of Research and Development.
NCT04309864 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04309864, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
For Veterans with spinal cord injury who use a wheelchair, pressure injuries related to sitting are a significant daily threat to well-being. Pressure injuries are costly to treat, negatively impact quality of life and community participation, and can be life threatening. Moving or shifting at regular intervals in the wheelchair redistributes harmful pressure and reduces risk for skin breakdown, yet these movements are a challenge to perform consistently. The challenge exists due to lack of sensation to let the individual know they need to shift their weight. Pressure mapping provides a detailed visual representation of pressure distribution and can compensate for impaired sensation. Pressure mapping feedback delivered on-demand on mobile platforms can potentially increase effectiveness in carrying out behaviors to reduce risk for pressure injury when used during clinician-delivered education to set goals and monitor progress and when used at home as a self-management strategy.
Primary Outcome
Aim 1a: The System Usability Scale (SUS) is a 10-item Likert scale (5-item ranging from strongly disagree to strongly agree) which will allow the participants (Veterans) to give their subjective assessment of the Smart watch as part of the CMAP system. Analysis will use Linear Mixed Effects Regression Model
Interventions
- DEVICE Use of CMAP app for education (in-hospital)
- DEVICE Use of CMAP app (in-home)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2025-07-31 |
| Phase | NA |
What the finished NCT04309864 record still lists
NCT04309864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Use of CMAP app for education (in-hospital) is the first listed.
NCT04309864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04309864 about?
NCT04309864 is a clinical study titled "CMAP Refinement for Pressure Injury Prevention". For Veterans with spinal cord injury who use a wheelchair, pressure injuries related to sitting are a significant daily threat to well-being. Pressure injuries are costly to treat, negatively impact quality of life and community participation, and can be life threatening. Moving or shifting at regul...
What is the current status of trial NCT04309864?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2020-06-01. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT04309864?
The interventions under investigation include: Use of CMAP app for education (in-hospital) (DEVICE), Use of CMAP app (in-home) (DEVICE).
Who is sponsoring clinical trial NCT04309864?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04309864's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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