CompletedNot Applicable

CMAP Refinement for Pressure Injury Prevention

United States26 participantsStarted 2020-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: For Aim 1a: * Veteran adults aged 18-80 * male and female * with a spinal cord injury (C4 and below) or spinal cord disorder with impaired sensory function and a wheelchair user for at least one year For Aim 2: Veteran adults aged 18-80, male and female, with a recent spinal cord injury (C4 and below) or a spinal cord disorder with impaired sensory function, who are currently in inpatient rehabilitation with at least 1 week prior to discharge. Participants must demonstrate ability to access the CMAP system application on a mobile phone or tablet independently. For Aim 3: * Veteran adults aged 18-80 * male and female * manual or power wheelchair users * at least one year post SCI onset * (C4 and below) or a spinal cord disorder with impaired sensory function * who are visiting the MVAHCS SCI/D Center for their annual visit or at end of a non-pressure injury stay in the hospital * at which time review of pressure injury prevention and assessment of wheelchair seating are routinely conducted by clinicians * Veterans using the CMAP system must demonstrate ability to access the CMAP app on a mobile phone or tablet independently Clinicians inclusion Criteria for Aim 1b; Aims 2 and 3: * Clinicians (SCI/D Physical and Occupational Therapists and Nurses and Ancillary Clinician) who, in their normal scope of work, provide patient education for pressure injury prevention Exclusion Criteria: For Aim 1a: * Any Veteran with SCI/D who is unable to verbally and …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Usability as measured by System Usability Scale (SUS)

Timeframe: Year 1-2: Change from baseline to second and third focus group

Usability as measured by User Experience Questionaire (UEQ)

Timeframe: Year 1-2: Change from baseline to second and third focus group

Change in Usability as measured by System Usability Scale (SUS)

Timeframe: Year 1-2: Change from baseline to second and third focus group

Change in Usability as measured by User Experience Questionaire (UEQ)

Timeframe: Year 1-2: Change from baseline to second and third focus group

Change in Usability as measured by System Usability Scale (SUS)

Timeframe: Year 2-3: compare final focus group score to after using in rehabilitation

Change in Usability as measured by User Experience Questionaire (UEQ)

Timeframe: Year 2-3: compare final focus group score to after using in rehabilitation

Trial details

NCT IDNCT04309864

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-07-31

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