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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Change in Self-Efficacy as measured by customized scale

Weight Shift bout comparisons

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,557 Total Patients Enrolled

Christine M. Olney, BSN MS PhDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN

Media Library

CMAP Refinement (Mobile App) Clinical Trial Eligibility Overview. Trial Name: NCT04309864 — N/A

Pressure Sore Research Study Groups: Usability-in-home, Usability-inpatients, Focus group-Clinicians, Focus group-Veteran

Pressure Sore Clinical Trial 2023: CMAP Refinement Highlights & Side Effects. Trial Name: NCT04309864 — N/A

CMAP Refinement (Mobile App) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04309864 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation extend to individuals who are 55 and over?

"The criteria for enrollment in this clinical trial dictates that individuals must be between the ages of 18 and 80 years old. Separately, there are 5 studies available for those under 18 and 39 trials for seniors aged 65 or older."

Answered by AI

According to the protocol, who can potentially partake in this research trial?

"This clinical trial is primarily seeking 46 individuals of all genders aged 18-80 who have pressure ulcers. Additionally, male and female veterans between those ages with a spinal cord injury (C4 or lower) or disorder impacting sensory function will be considered if they are currently inpatient rehabilitating for at least one week prior to discharge. All participants must demonstrate the ability to independently operate the CMAP system application on either a mobile phone or tablet device and need to have been using a manual/power wheelchair for over 12 months post SCI onset. Furthermore, veterans utilising this app must exhibit self-sufficiency when it comes to utilizing said technology"

Answered by AI

Is the recruitment process for this research still underway?

"Affirmative. Clinicaltrials.gov verifies that this clinical trial, which was first announced on June 1st 2020, is actively looking for participants. 46 individuals need to be enrolled from a single medical centre."

Answered by AI

How many individuals have been recruited for this medical trial thus far?

"Affirmative. As indicated by clinicaltrials.gov, the medical trial that was first posted on June 1st 2020 is actively searching for 46 individuals to be enrolled at a single site. The study has been updated as of April 29th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CMAP Refinement for Pressure Injury Prevention

2020. "CMAP Refinement for Pressure Injury Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04309864.