CMAP Refinement for Pressure Injury Prevention

NCT04309864 | Completed FDA Device

• 1 other identifier: B3222-R
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcer

Keywords

skin ulcer; wounds and injuries; decubitus ulcer; wheel chairs; spinal cord injury; seating; pressure injury prevention

Outcome Measures

Primary Outcomes (12)

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

  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

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

• Usability as measured by User Experience Questionaire (UEQ)

  Aim 1a: 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. Analysis will use Linear Mixed Effects Regression Model.

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

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

  Aim 1b: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. Analysis will use Linear Mixed Effects Regression Model

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

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

  Aim 1b: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. Analysis will use Linear Mixed Effects Regression Model.

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

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

  Aim 2: 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. Analysis will use Linear Mixed Effects Regression Model

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

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

  Aim 2: 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. Analysis will use Linear Mixed Effects Regression Model.

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

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

  Aim 2: 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. Analysis will use Linear Mixed Effects Regression Model

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

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

  Aim 2: 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. Analysis will use Linear Mixed Effects Regression Model.

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

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

  Aim 3: 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 . Analysis will use Linear Mixed Effects Regression Model.

  Year 4: compare initial and final use in the out patient and home setting

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

  Aim 3: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. Analysis will use Linear Mixed Effects Regression Model.

  Year 4: compare initial and final use in the home setting

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

  Aim 3: 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. Analysis will use Linear Mixed Effects Regression Model.

  Year 4: compare initial and final use in the home setting

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

  Aim 3: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 . Analysis will use Linear Mixed Effects Regression Model.

  Year 4: compare initial and final use in the home setting

Secondary Outcomes (5)

• Change in Self-Efficacy as measured by Skin Care Belief Scale

  Year 2-3: Pre post use of the CMAP system

• Change in Self-Efficacy as measured by customized scale

  Year 2-3: Pre post use of the CMAP system

• Change in Self-Efficacy as measured by Skin Care Belief Scale

  Year 4: Pre post use of the CMAP system

• Change in Self-Efficacy as measured by customized scale

  Year 4: Pre post use of the CMAP system

• Weight Shift bout comparisons

  Year 4

Study Arms (4)

Focus group-Veteran

NO INTERVENTION

Veterans will inform study staff regarding desired device design refinements

Focus group-Clinicians

NO INTERVENTION

Clinicians will inform study staff regarding desired app design changes

Usability-inpatients

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.

Device: Use of CMAP app for education (in-hospital)

Usability-in-home

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.

Device: Use of CMAP app (in-home)

Interventions

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.

Usability-inpatients

Use of CMAP app (in-home) DEVICE

The Veteran will use the CMAP system at home for two weeks during their daily routines.

Usability-in-home

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Skin Ulcer; Wounds and Injuries; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System

Study Officials

• Byron W Eddy

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

• Christine M. Olney, BSN MS PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 16, 2020
• Study Start: June 1, 2020
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: At the completion of the study.
• Access Criteria: Upon request once the study data analysis are completed and published.

Locations

US (1)