Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
1 other identifier
interventional
144
1 country
5
Brief Summary
Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in FY10 was just under $400 million.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2008
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
January 8, 2015
CompletedApril 27, 2015
October 1, 2014
2.6 years
September 26, 2008
November 24, 2014
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percent of Possible Self-Reported Skin Care Behaviors
Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline). The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge.
Admission (Baseline), 3 months, 6 months
Skin Behavior Change
Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms. The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge.
Admission (Baseline), 3 months, 6 months
Any Skin Worsening
Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have \>20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
6 months
Skin Status
Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have \>20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
Admission (Baseline), 3 months, 6 months
Secondary Outcomes (1)
Mean Number of Skin-related Admissions
Discharge to end of study (6 months)
Study Arms (2)
SM+MI
EXPERIMENTALSelf Management (SM) + Motivational Interviewing (MI). Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. Motivational Interviewing (MI) is an evidence-based form of counseling to help individuals to engage in behavior change. Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
ED
ACTIVE COMPARATOREducation (ED). An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
Interventions
Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures.
The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
Eligibility Criteria
You may qualify if:
- over 18 years of age,
- SCI of at least six month's duration,
- hospitalized for a Stage III or IV PrU,
- cognitively intact,
- available for telephone follow-up, and
- discharged to a community setting or able to direct own care.
You may not qualify if:
- We excluded patients with a terminal diagnosis, severe psychiatric comorbidities (eg, current psychosis), cognitive impairments that limited their ability to consent or participate, severe hearing loss, and wounds not expected to heal. People discharged to nursing homes unable to direct their own care were also excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822, United States
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, 30904, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030, United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000, United States
Related Publications (1)
Guihan M, Bombardier CH, Ehde DM, Rapacki LM, Rogers TJ, Bates-Jensen B, Thomas FP, Parachuri R, Holmes SA. Comparing multicomponent interventions to improve skin care behaviors and prevent recurrence in veterans hospitalized for severe pressure ulcers. Arch Phys Med Rehabil. 2014 Jul;95(7):1246-1253.e3. doi: 10.1016/j.apmr.2014.01.012. Epub 2014 Jan 30.
PMID: 24486242RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was underpowered because of difficulties encountered with recruitment and retention. Delivering an adequate "dose" of the treatments and site coordinator fidelity to the MI intervention were also limitations.
Results Point of Contact
- Title
- Marylou Guihan, PhD
- Organization
- Center of Innovation for Complex Chronic Health Care
Study Officials
- PRINCIPAL INVESTIGATOR
Marylou Guihan, PhD MA BA
Edward Hines Jr. VA Hospital, Hines, IL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
November 1, 2008
Primary Completion
June 1, 2011
Study Completion
December 1, 2011
Last Updated
April 27, 2015
Results First Posted
January 8, 2015
Record last verified: 2014-10