Pressure UlcerNCT04309864
CMAP Refinement for Pressure Injury Prevention
A study testing Use of CMAP app for education (in-hospital) and Use of CMAP app (in-home) in people with Pressure Ulcer, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Use of CMAP app for education (in-hospital) and Use of CMAP app (in-home)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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
Who cannot join
- For Aim 1a:
- Any Veteran with SCI/D who is unable to verbally and cognitively communicate with the study team
- For Aims 2, and 3:
- Any Veteran with SCI/D who has an active pressure injury that contacts their seating system or within six months of a flap surgery
- Any Veteran with SCI/D who is unable to verbally and cognitively communicate with the study team
- Any Veteran whose seat cushion is a customized immersion style
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
About this study
Official title: Refinement of the Comprehensive Mobile Assessment of Pressure (CMAP) System for Prevention of Pressure Injuries
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.
Read the detailed description
Objectives: The long-term goal of this project is to improve the effectiveness of pressure injury prevention education by clinicians and self-management by Veterans with spinal cord injury (SCI) through a methodical development and testing of a mobile platform based pressure mapping system called "Comprehensive Mobile Assessment of Pressure" (CMAP). The targeted risk-reduction behavior in this project is the effective use of weight shifts when sitting in a wheelchair by improving consistency, frequency, duration, and quality of movements to redistribute pressure. CMAP provides visual cues as well as individually customizable reminders that are designed to compensate for the lack of sensation that prevents the use of natural cues to redistribute pressure, by wheelchair users. An updated CMAP system will serve two important objectives: 1) assist clinicians in assessment, individualized goal-setting, and monitoring the Veteran with SCI's progress toward pressure injury prevention behavior goals while in the hospital setting; and 2) assist clinicians with individualized setup and education of the Veteran with SCI for using the CMAP system in the home setting as a self-management strategy for pressure injury prevention.
Specific Aims: The specific aims of this study include: 1a) hardware expansion to improve functionality of the CMAP system to add a docking and charging station and use of CMAP on a smartwatch based on Veteran preferences and 1b) software expansion to enhance clinical education for pressure injury prevention education, with requirements provided by clinicians; 2) determine usability of the refined CMAP system when it is integrated into patient education for Veteran's with acute SCI during their inpatient rehabilitation stay, and 3) a determine usability and efficacy of the refined CMAP system for clinician-delivered pressure injury prevention education, followed by Veteran use of CMAP in their daily routines at home.
Study Design: This four-year study will have multiple stages and will use a mixed methods approach that includes iterative focus groups and interviews with Veterans who have SCI and with clinicians who provide pressure injury prevention education to Veterans with SCI; self-efficacy and usability surveys for both Veterans and clinicians; pilot testing of CMAP during inpatient rehabilitation and testing during outpatient visits. Repeated measures will be used to evaluate changes within subject for completion of weight shifts while using CMAP, compared to periods when not using CMAP.
Methods: During the first two years, improvements to CMAP hardware and software will be guided by experience-based design guided requirements learned about through iterative focus groups including Veterans with SCI/D (n=10) and clinicians (n=10). Usability will be measured at each iteration of development using the System Usability Scale (SUS) and the User Experience Questionnaire (UEQ). The focus groups will be repeated to ensure alignment between development progress and the requirements identified by the focus groups. During the inpatient pilot test, clinician (n=3) and Veteran (n=6) self-efficacy will be measured. Veterans will complete selected sub-scales from the Skin Care Belief Scale and clinicians will answer survey questions developed specifically around providing education for performing weight shifts effectively. Veteran progress toward weight shift goals will be measured through performance monitoring within the CMAP app; Actual performance will be assessed against the individualized goals set by the clinician. During the outpatient testing, Veterans (n=20) will use CMAP at home for 2 weeks after receiving education and individualized goals for weight shift performance by clinicians. While at home, trunk movements will be monitored via actigraphy to monitor weight shift frequency to compare to baseline trunk movement data, weight shift performance data within CMAP app, and finally, compared with individualized goals for performing weight shifts. Self efficacy and usability (SUS and UEQ) of the overall system in both settings will be measured.
- Conditions
- Pressure Ulcer
- Being tested
- Use of CMAP app for education (in-hospital), Use of CMAP app (in-home)
- Keywords
- skin ulcer, wounds and injuries, decubitus ulcer, wheel chairs, spinal cord injury, seating, pressure injury prevention
- Medical subject headings
- Pressure Ulcer, Skin Ulcer, Wounds and Injuries, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of CMAP app for education (in-hospital)Device
Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation.
Use of CMAP app (in-home)Device
The Veteran will use the CMAP system at home for two weeks during their daily routines.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 Veteran Focus Group 1 | No intervention | Veterans will inform study staff regarding desired device design refinements over three focus groups. Outcome measures are collected for Focus Groups 1 and 3. |
| Aim 1 Clinician Focus Group 1 | No intervention | Clinicians will inform study staff regarding desired app design changes over three focus groups. Outcome measures are collected for Focus Groups 1 and 3. |
| Aim 2 Veterans | Other | Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation. Receives: Device: Use of CMAP app for education (in-hospital) |
| Aim 3 Veterans | Other | The Veteran will use the CMAP system at home for two weeks to use in their daily routines, along with wearing the acti-graph one week prior, two weeks during and one week after CMAP usage. Receives: Device: Use of CMAP app (in-home) |
| Aim 2 Clinicians | Other | Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation. Receives: Device: Use of CMAP app for education (in-hospital) |
| Aim 3 Clinicians | Other | The Veteran will use the CMAP system at home for two weeks to use in their daily routines, along with wearing the acti-graph one week prior, two weeks during and one week after CMAP usage. Receives: Device: Use of CMAP app (in-home) |
| Aim 1 Clinician Focus Group 3 | No intervention | Clinicians will inform study staff regarding desired app design changes over three focus groups. Outcome measures are collected for Focus Groups 1 and 3. |
| Aim 1 Veteran Focus Group 3 | No intervention | Veterans will inform study staff regarding desired device design refinements over three focus groups. Outcome measures are collected for Focus Groups 1 and 3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Usability as Measured by System Usability Scale (SUS)
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. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)
Usability as Measured by User Experience Questionnaire (UEQ)
The User Experience Questionnaire (UEQ) is a 26 item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participant's (Veterans) impression of the of their experience with the Smart watch as part of the CMAP system. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)
Change in Usability as Measured by System Usability Scale (SUS)
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 (clinicians) to give their subjective assessment of the newly developed educational formats in the CMAP system. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)
Change in Usability as Measured by User Experience Questionnaire (UEQ)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (clinicians) impression of the of their experience with the newly developed educational formats of the CMAP system. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)
Change in Usability as Measured by System Usability Scale (SUS)
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 CMAP system after using it during their acute rehabilitation. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model
Measured: Change from Aim 1 Focus Group 3 (at time of enrollment) to end of Aim 2 intervention (10 days following Aim 2 enrollment)
Change in Usability as Measured by User Experience Questionnaire (UEQ)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (Veterans) impression of the of their experience with the CMAP system after using it during Veterans' during their acute rehabilitation. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Aim 1 Focus Group 3 (at time of enrollment) to end of Aim 2 intervention (10 days following Aim 2 enrollment)
Change in Usability as Measured by System Usability Scale (SUS)
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 (clinicians) to give their subjective assessment of the educational formats in the CMAP system after using it for Veterans' acute rehabilitation. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model
Measured: Change from Aim 1 Focus Group 3 (at time of enrollment) to end of Aim 2 intervention (10 days following Aim 2 enrollment for each Veteran case)
Change in Usability as Measured by User Experience Questionnaire (UEQ)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (clinicians) impression of the of their experience with the CMAP educational formats after using it for Veterans' acute rehabilitation. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Aim 1 Focus Group 3 (at time of enrollment) to end of Aim 2 intervention (10 days following Aim 2 enrollment for each Veteran case)
Change in Usability as Measured by System Usability Scale (SUS)
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 CMAP system after using it in the outpatient and community-based settings. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 participation (3 weeks following enrollment)
Change in Usability as Measured by User Experience Questionnaire (UEQ)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (Veterans) impression of the of their experience with the CMAP system at the start of intervention and after using the CMAP system in the outpatient and community-based settings. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 participation (3 weeks following enrollment)
Change in Usability as Measured by System Usability Scale (SUS)
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 (clinicians) to give their subjective assessment of the educational formats in the CMAP system after using it for Veterans' in the outpatient and community-based settings. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 activities (about 10 months following enrollment)
Change in Usability as Measured by User Experience Questionnaire (UEQ)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (clinicians) impression of the of their experience with the CMAP educational formats at the start of intervention and after using the CMAP system in the outpatient and community-based settings. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Measured: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 activities (about 10 months following enrollment)
Secondary outcomes (4)
Pressure Ulcer Knowledge Test
The Pressure Ulcer Knowledge Test is a 9-item multiple choice survey intended to assess individuals' knowledge of pressure injury prevention activities and treatments. Total score is reported, with range 9-27. Higher scores indicate better understanding of pressure injury prevention practices.
Measured: Change from Aim 2 baseline (time of enrollment) to end of Aim 2 intervention (10 days following enrollment)
Therapist Self-Efficacy for Weight Shifts to Prevent Pressure Injuries
This self-efficacy measures clinician confidence in delivering pressure injury prevention education, specifically around instruction of how to perform weight shifts using the CMAP system during Veterans' acute rehabilitation. Total scores are reported, with range 4-40. Higher scores indicate better self-efficacy.
Measured: Change from Aim 2 baseline (time of enrollment) to end of Aim 2 intervention (10 days following enrollment for each Veteran case)
Pressure Ulcer Knowledge Test
The Pressure Ulcer Knowledge Test is a 9-item multiple choice survey intended to assess individuals' knowledge of pressure injury prevention activities and treatments. Total score is reported, with range 9-27. Higher scores indicate better understanding of pressure injury prevention practices.
Measured: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 participation (3 weeks following enrollment)
Therapist Self-Efficacy for Weight Shifts to Prevent Pressure Injuries
This self-efficacy measures clinician confidence in delivering pressure injury prevention education, specifically around instruction of how to perform weight shifts using the CMAP system during Veterans' acute rehabilitation. Total scores are reported, with range 4-40. Higher scores indicate better self-efficacy.
Measured: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 activities (about 10 months following enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Jun 2020
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Initially, Veteran focus groups will inform researchers regarding needed device refinements; clinician focus groups will inform regarding app updates; then participants will trial the updated seating app for usability.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Byron W Eddy, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MNChristine M. Olney, BSN MS PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309864
- Sponsor's protocol ID
- B3222-R
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2020
- Last updated
- 9 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared upon request, per VA requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement of the Comprehensive Mobile Assessment of Pressure (CMAP) System for Prevention of Pressure Injuries
- ClinicalTrials.gov ID
- NCT04309864
- Acronym / sponsor ID
- B3222-R
- Conditions
- Pressure Ulcer
- Keywords
- skin ulcer, wounds and injuries, decubitus ulcer, wheel chairs, spinal cord injury, seating, pressure injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Posted 9 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives: The long-term goal of this project is to improve the effectiveness of pressure injury prevention education by clinicians and self-management by Veterans with spinal cord injury (SCI) through a methodical development and testing of a mobile platform based pressure mapping system called "Comprehensive Mobile Assessment of Pressure" (CMAP). The targeted risk-reduction behavior in this project is the effective use of weight shifts when sitting in a wheelchair by improving consistency, frequency, duration, and quality of movements to redistribute pressure. CMAP provides visual cues as well as individually customizable reminders that are designed to compensate for the lack of sensation that prevents the use of natural cues to redistribute pressure, by wheelchair users. An updated CMAP system will serve two important objectives: 1) assist clinicians in assessment, individualized goal-setting, and monitoring the Veteran with SCI's progress toward pressure injury prevention behavior goals while in the hospital setting; and 2) assist clinicians with individualized setup and education of the Veteran with SCI for using the CMAP system in the home setting as a self-management strategy for pressure injury prevention.
Specific Aims: The specific aims of this study include: 1a) hardware expansion to improve functionality of the CMAP system to add a docking and charging station and use of CMAP on a smartwatch based on Veteran preferences and 1b) software expansion to enhance clinical education for pressure injury prevention education, with requirements provided by clinicians; 2) determine usability of the refined CMAP system when it is integrated into patient education for Veteran's with acute SCI during their inpatient rehabilitation stay, and 3) a determine usability and efficacy of the refined CMAP system for clinician-delivered pressure injury prevention education, followed by Veteran use of CMAP in their daily routines at home.
Study Design: This four-year study will have multiple stages and will use a mixed methods approach that includes iterative focus groups and interviews with Veterans who have SCI and with clinicians who provide pressure injury prevention education to Veterans with SCI; self-efficacy and usability surveys for both Veterans and clinicians; pilot testing of CMAP during inpatient rehabilitation and testing during outpatient visits. Repeated measures will be used to evaluate changes within subject for completion of weight shifts while using CMAP, compared to periods when not using CMAP.
Methods: During the first two years, improvements to CMAP hardware and software will be guided by experience-based design guided requirements learned about through iterative focus groups including Veterans with SCI/D (n=10) and clinicians (n=10). Usability will be measured at each iteration of development using the System Usability Scale (SUS) and the User Experience Questionnaire (UEQ). The focus groups will be repeated to ensure alignment between development progress and the requirements identified by the focus groups. During the inpatient pilot test, clinician (n=3) and Veteran (n=6) self-efficacy will be measured. Veterans will complete selected sub-scales from the Skin Care Belief Scale and clinicians will answer survey questions developed specifically around providing education for performing weight shifts effectively. Veteran progress toward weight shift goals will be measured through performance monitoring within the CMAP app; Actual performance will be assessed against the individualized goals set by the clinician. During the outpatient testing, Veterans (n=20) will use CMAP at home for 2 weeks after receiving education and individualized goals for weight shift performance by clinicians. While at home, trunk movements will be monitored via actigraphy to monitor weight shift frequency to compare to baseline trunk movement data, weight shift performance data within CMAP app, and finally, compared with individualized goals for performing weight shifts. Self efficacy and usability (SUS and UEQ) of the overall system in both settings will be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Initially, Veteran focus groups will inform researchers regarding needed device refinements; clinician focus groups will inform regarding app updates; then participants will trial the updated seating app for usability.
| Arm | Type | Receives |
|---|---|---|
| Aim 1 Veteran Focus Group 1 | No intervention | –Veterans will inform study staff regarding desired device design refinements over three focus groups. Outcome measures are collected for Focus Groups 1 and 3. |
| Aim 1 Clinician Focus Group 1 | No intervention | –Clinicians will inform study staff regarding desired app design changes over three focus groups. Outcome measures are collected for Focus Groups 1 and 3. |
| Aim 2 Veterans | Other | Device: Use of CMAP app for education (in-hospital)Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation. |
| Aim 3 Veterans | Other | Device: Use of CMAP app (in-home)The Veteran will use the CMAP system at home for two weeks to use in their daily routines, along with wearing the acti-graph one week prior, two weeks during and one week after CMAP usage. |
| Aim 2 Clinicians | Other | Device: Use of CMAP app for education (in-hospital)Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation. |
| Aim 3 Clinicians | Other | Device: Use of CMAP app (in-home)The Veteran will use the CMAP system at home for two weeks to use in their daily routines, along with wearing the acti-graph one week prior, two weeks during and one week after CMAP usage. |
| Aim 1 Clinician Focus Group 3 | No intervention | –Clinicians will inform study staff regarding desired app design changes over three focus groups. Outcome measures are collected for Focus Groups 1 and 3. |
| Aim 1 Veteran Focus Group 3 | No intervention | –Veterans will inform study staff regarding desired device design refinements over three focus groups. Outcome measures are collected for Focus Groups 1 and 3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Veteran adults aged 18-80
Key exclusion criteria (6 listed)
- Any Veteran with SCI/D who is unable to verbally and cognitively communicate with the study team
- Any Veteran with SCI/D who has an active pressure injury that contacts their seating system or within six months of a flap surgery
- Any Veteran with SCI/D who is unable to verbally and cognitively communicate with the study team
- Any Veteran whose seat cushion is a customized immersion style
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of CMAP app for education (in-hospital)Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation. | Device | Aim 2 Clinicians, Aim 2 Veterans |
| Use of CMAP app (in-home)The Veteran will use the CMAP system at home for two weeks during their daily routines. | Device | Aim 3 Clinicians, Aim 3 Veterans |
Primary outcome
Change in Usability as Measured by System Usability Scale (SUS)
Time frame: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)
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. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model.
Usability as Measured by User Experience Questionnaire (UEQ)
Time frame: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)
The User Experience Questionnaire (UEQ) is a 26 item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participant's (Veterans) impression of the of their experience with the Smart watch as part of the CMAP system. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Change in Usability as Measured by System Usability Scale (SUS)
Time frame: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)
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 (clinicians) to give their subjective assessment of the newly developed educational formats in the CMAP system. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model.
Change in Usability as Measured by User Experience Questionnaire (UEQ)
Time frame: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (clinicians) impression of the of their experience with the newly developed educational formats of the CMAP system. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Change in Usability as Measured by System Usability Scale (SUS)
Time frame: Change from Aim 1 Focus Group 3 (at time of enrollment) to end of Aim 2 intervention (10 days following Aim 2 enrollment)
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 CMAP system after using it during their acute rehabilitation. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model
Change in Usability as Measured by User Experience Questionnaire (UEQ)
Time frame: Change from Aim 1 Focus Group 3 (at time of enrollment) to end of Aim 2 intervention (10 days following Aim 2 enrollment)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (Veterans) impression of the of their experience with the CMAP system after using it during Veterans' during their acute rehabilitation. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Change in Usability as Measured by System Usability Scale (SUS)
Time frame: Change from Aim 1 Focus Group 3 (at time of enrollment) to end of Aim 2 intervention (10 days following Aim 2 enrollment for each Veteran case)
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 (clinicians) to give their subjective assessment of the educational formats in the CMAP system after using it for Veterans' acute rehabilitation. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model
Change in Usability as Measured by User Experience Questionnaire (UEQ)
Time frame: Change from Aim 1 Focus Group 3 (at time of enrollment) to end of Aim 2 intervention (10 days following Aim 2 enrollment for each Veteran case)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (clinicians) impression of the of their experience with the CMAP educational formats after using it for Veterans' acute rehabilitation. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Change in Usability as Measured by System Usability Scale (SUS)
Time frame: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 participation (3 weeks following enrollment)
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 CMAP system after using it in the outpatient and community-based settings. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model.
Change in Usability as Measured by User Experience Questionnaire (UEQ)
Time frame: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 participation (3 weeks following enrollment)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (Veterans) impression of the of their experience with the CMAP system at the start of intervention and after using the CMAP system in the outpatient and community-based settings. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
Change in Usability as Measured by System Usability Scale (SUS)
Time frame: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 activities (about 10 months following enrollment)
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 (clinicians) to give their subjective assessment of the educational formats in the CMAP system after using it for Veterans' in the outpatient and community-based settings. Total scale 0-100, where higher scores are considered highly favorable. Analysis will use Linear Mixed Effects Regression Model.
Change in Usability as Measured by User Experience Questionnaire (UEQ)
Time frame: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 activities (about 10 months following enrollment)
The User Experience Questionnaire (UEQ) is a 26 -item semantic differential arranged on six scales (attractiveness, perspicuity, efficiency, dependability, stimulation, and, novelty) which will measure the participants' (clinicians) impression of the of their experience with the CMAP educational formats at the start of intervention and after using the CMAP system in the outpatient and community-based settings. Total scale range 1 - 7, where lower numbers indicate agreement. Analysis will use Linear Mixed Effects Regression Model.
4 secondary outcomes
Pressure Ulcer Knowledge Test
Time frame: Change from Aim 2 baseline (time of enrollment) to end of Aim 2 intervention (10 days following enrollment)
Therapist Self-Efficacy for Weight Shifts to Prevent Pressure Injuries
Time frame: Change from Aim 2 baseline (time of enrollment) to end of Aim 2 intervention (10 days following enrollment for each Veteran case)
Pressure Ulcer Knowledge Test
Time frame: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 participation (3 weeks following enrollment)
Therapist Self-Efficacy for Weight Shifts to Prevent Pressure Injuries
Time frame: Change from Aim 3 baseline (time of enrollment) to end of Aim 3 activities (about 10 months following enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon request, per VA requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byron W Eddy principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
Christine M. Olney, BSN MS PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of CMAP app for education (in-hospital) and Use of CMAP app (in-home) in people with Pressure Ulcer, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Usability as Measured by System Usability Scale (SUS) (time frame: Change from Focus Group 1 (at time of enrollment) to Focus Group 3 (at time of enrollment, 2 years after Focus Group 1)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.