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Mobile App

CMAP App for Pressure Sore Prevention

N/A

Recruiting

Led By Christine M. Olney, BSN MS PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 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

Must not have

For Aim 1a: Any Veteran with SCI/D who is unable to verbally and cognitively communicate with the study team

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 1-2: change from baseline to second and third focus group

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether using a pressure-mapping device on a mobile platform will help Veterans with spinal cord injury and pressure injuries related to sitting in a wheelchair.

Who is the study for?

This trial is for Veterans aged 18-80 with spinal cord injuries or disorders, who use a wheelchair and have impaired sensory function. They must be able to independently access the CMAP app on a mobile device. Excluded are those with active pressure injuries that contact their seating system, recent flap surgery, cognitive communication issues, or using customized immersion style seat cushions.

What is being tested?

The study tests if using the CMAP app for education in hospitals and at home can help prevent pressure injuries in Veterans with spinal cord injury. The app provides visual feedback on pressure distribution to encourage regular movement and weight shifting while sitting.

What are the potential side effects?

Since this intervention involves educational software rather than medication, traditional side effects are not applicable. However, participants may experience frustration or difficulty if they find the technology challenging to use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a veteran aged 18-80 with a recent spinal cord injury or disorder, can use a mobile app, and am in rehab.

Select...

I am a veteran aged 18-80 with a spinal cord injury (C4 or lower) or disorder, use a wheelchair, and have had impaired sensory function for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a Veteran with spinal cord injury/disease and cannot communicate verbally or cognitively.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 1-2: change from baseline to second and third focus group

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 1-2: change from baseline to second and third focus group

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1-2: change from baseline to second and third focus group for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Usability as measured by User Experience Questionaire (UEQ)

Secondary study objectives

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

Change in Self-Efficacy as measured by customized scale

Weight Shift bout comparisons

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Usability-inpatientsExperimental Treatment1 Intervention

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.

Group II: Usability-in-homeExperimental Treatment1 Intervention

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.

Group III: Focus group-CliniciansActive Control1 Intervention

Clinicians will inform study staff regarding desired app design changes

Group IV: Focus group-VeteranActive Control1 Intervention

Veterans will inform study staff regarding desired device design refinements

0 / 3Eligibility criteria met