N/A
N=144
Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
Pressure Ulcers · Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT00763282 ↗Enrolled (actual)
144
Serious AEs
4.9%
Results posted
Jan 2015
Primary outcome: Primary: Percent of Possible Self-Reported Skin Care Behaviors — 73.8; 74.1; 83.5; 79.5 % of Possible Self-Reported Behaviors
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self Management (SM) (Behavioral); Motivational Interviewing (MI) (Behavioral); Education (ED) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Possible Self-Reported Skin Care Behaviors |
73.8; 74.1; 83.5; 79.5; 85.0; 83.0 | — |
| PRIMARY Skin Behavior Change |
9.7; 5.4; 11.3; 8.9 | — |
| PRIMARY Any Skin Worsening |
36; 33; 35; 39 | — |
| PRIMARY Skin Status |
36; 33; 26; 28; 9; 11 | — |
| SECONDARY Mean Number of Skin-related Admissions |
1.5; 1.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00763282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.