CMAP App for Pressure Sore Prevention

Overseen By Byron W Eddy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active pressure injury, Flap surgery, Customized cushion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

46 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app for pressure sore prevention, so it's unlikely that medication changes are required.

What data supports the effectiveness of the CMAP App for Pressure Sore Prevention treatment?

Research shows that continuous bedside pressure mapping technology helps identify areas of high pressure on the skin, allowing for better patient repositioning to prevent pressure injuries. This suggests that similar technology used in the CMAP App could be effective in preventing pressure sores. ^{1 2 3 4 5}

Is the CMAP App for Pressure Sore Prevention safe for humans?

The studies on similar technologies, like computerized mattress systems and continuous bedside pressure mapping, focus on preventing pressure sores by monitoring and adjusting pressure on the skin. These studies do not report any safety concerns, suggesting that the technology is generally safe for human use. ^{1 3 4 6 7}

How is the CMAP Refinement treatment different from other treatments for pressure sore prevention?

The CMAP Refinement treatment uses pressure mapping technology to continuously monitor and adjust the pressure between the skin and the supporting surface, helping to prevent pressure sores by ensuring optimal pressure distribution. This approach is unique because it provides real-time feedback and adjustments, unlike traditional methods that rely on periodic manual repositioning. ^{1 3 8 9 10}

Research Team

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

Eligibility Criteria

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.

Inclusion Criteria

I am a veteran aged 18-80, use a wheelchair, and have had a spinal injury or disorder for over a year.

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

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

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

You have a pressure injury that touches your seat or had flap surgery in the last six months, difficulty communicating with the study team, or a customized immersion seat cushion.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Testing

Iterative focus groups and interviews with Veterans and clinicians to guide CMAP system improvements

2 years

Multiple focus group sessions

Inpatient Pilot Testing

Pilot testing of CMAP during inpatient rehabilitation to measure usability and self-efficacy

Varies

Inpatient rehabilitation stay

Outpatient Testing

Veterans use CMAP at home for 2 weeks with monitoring of weight shift frequency

2 weeks

Home use with actigraphy monitoring

Follow-up

Participants are monitored for usability and self-efficacy after using the CMAP system

4 weeks

Treatment Details

Interventions

• CMAP Refinement

Trial Overview 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.

Participant Groups

Group I: Usability-inpatients Experimental Treatment 1 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-home Experimental Treatment 1 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-Clinicians Active Control 1 Intervention

Clinicians will inform study staff regarding desired app design changes

Group IV: Focus group-Veteran Active Control 1 Intervention

Veterans will inform study staff regarding desired device design refinements

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

In a study involving 678 patients, the use of Continuous Bedside Pressure Mapping (CBPM) technology did not show a statistically significant reduction in interface pressure or the incidence of pressure injuries compared to standard care.

Despite the lack of significant findings, the study suggests that longer monitoring periods and combining CBPM with other interventions may be necessary to effectively prevent pressure injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Continuous Bedside Pressure Mapping System for Reducing Interface Pressures: A Randomized Clinical Trial. Ho, C., Ocampo, W., Southern, DA., et al.[2023]

A study involving over 3,000 patients across seven UK hospitals established a reliable method for measuring the prevalence of pressure damage, allowing for effective comparisons and interpretations of national data.

The findings highlight the importance of developing effective prevention and treatment strategies for pressure sores, as they significantly increase treatment costs and patient length of stay, making this survey a valuable tool for quality improvement in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of pressure damage in hospital patients in the UK. O'Dea, K.[2019]

A preliminary study involving 12 patients with spinal cord lesions showed that a computerized mattress system effectively prevented bed sores by continuously monitoring and adjusting pressure, with no signs of redness or excessive perspiration observed after up to 4 hours of use.

The mattress maintained a safe interface pressure of 22-30 mm Hg and was well-received by patients and staff, suggesting it could enhance comfort and potentially reduce the frequency of repositioning needed to prevent sores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of a novel approach to sore prevention in patients with spinal cord lesions: the computerized dynamic control Matrix 200 system. Catz, A., Philo, O., Gilad, N., et al.[2017]

A scoping review of nine studies highlighted that point-of-care subepidermal moisture devices, used primarily by nurses, can help identify localized edema as a risk factor for pressure injuries, but their use is inconsistent and lacks standardization.

Despite the recognition of these devices' potential value in clinical practice, significant knowledge gaps exist regarding their application and interpretation, indicating a need for further research to establish standardized procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of point-of-care subepidermal moisture devices to detect localised oedema and evaluate pressure injury risk: A scoping review. McLaren-Kennedy, A., Chaboyer, W., Carlini, J., et al.[2023]

In a series of three prevalence surveys conducted in a teaching hospital with a total mean pressure sore prevalence of 7.32%, grades 2 and 3 pressure sores were most commonly reported, particularly on the sacrum.

The stability in patient risk levels, as assessed by the Waterlow score, suggests that while overall prevalence varied, the majority of patients remained consistently categorized as at no risk, at risk, or at high risk, providing a reliable basis for selecting pressure-relieving equipment and monitoring prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The size of the pressure-sore problem in a teaching hospital. Dealey, C.[2019]

The study evaluates the durability of mattresses designed for pressure sore prevention, which is crucial for ensuring long-term effectiveness in patient care.

Understanding mattress durability helps in selecting appropriate products that can maintain their protective qualities over time, ultimately improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From the Journals. Jones, V., Banks, V.[2019]

A study involving 100 patients at risk for pressure ulcers showed that a novel infrared imaging device accurately predicted all 5 participants who developed early-stage pressure ulcers, including their specific locations.

In contrast, the traditional Braden Scale only identified 3 out of the 5 participants at risk, highlighting the potential of infrared imaging as a more objective and effective tool for preventing pressure ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the detection of pressure ulcers using the TMI ImageMed system. Judy, D., Brooks, B., Fennie, K., et al.[2010]

A mobile application was developed to assist healthcare providers in preventing and treating pressure injuries, incorporating features like risk factor evaluation, wound assessment, and treatment recommendations based on a thorough literature review of 21 sources.

The app is designed with an easy-to-use interface, making it a practical tool for clinicians to enhance patient care and promote effective nursing interventions for pressure injury management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Mobile App for Prevention and Treatment of Pressure Injuries. Salomé, GM., Ferreira, LM.[2018]

A new device has been developed to continuously monitor pressure relief for wheelchair users, helping to prevent pressure sores by signaling when to relieve pressure based on individual performance.

The device collects data that can be used both clinically and for research, enhancing the understanding of effective pressure relief techniques and improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheelchair-based mobile measurement of behavior for pressure sore prevention. Grip, JC., Merbitz, CT.[2019]

Pressure mapping systems are a reliable method for assessing interface pressures in seating, showing significant agreement among both experienced occupational therapists and students with no prior experience.

The study demonstrated that using pressure maps alone is effective for interpreting pressure distribution, providing consistent results across various seating surfaces tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure mapping systems: reliability of pressure map interpretation. Stinson, MD., Porter-Armstrong, AP., Eakin, PA.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of a Continuous Bedside Pressure Mapping System for Reducing Interface Pressures: A Randomized Clinical Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Prevalence of pressure damage in hospital patients in the UK. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility study of a novel approach to sore prevention in patients with spinal cord lesions: the computerized dynamic control Matrix 200 system. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Use of point-of-care subepidermal moisture devices to detect localised oedema and evaluate pressure injury risk: A scoping review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The size of the pressure-sore problem in a teaching hospital. [2019]

6. England pubmed.ncbi.nlm.nih.gov

From the Journals. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Improving the detection of pressure ulcers using the TMI ImageMed system. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Developing a Mobile App for Prevention and Treatment of Pressure Injuries. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

Wheelchair-based mobile measurement of behavior for pressure sore prevention. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Pressure mapping systems: reliability of pressure map interpretation. [2017]