CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
Self Management (SM) +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00763282
NCT00763282N/ACompleted

Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury

US Department of Veterans Affairs·interventional·Posted Sep 30, 2008·Updated Apr 27, 2015

In Brief

A clinical study evaluating Self Management (SM), Motivational Interviewing (MI), and 1 other intervention for Pressure Ulcers and Spinal Cord Injuries. Completed, enrolled 144 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2008
Enrollment StartNov 1, 2008
Primary CompletionJun 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.8 years ago

Interventions

Self Management (SM)behavioral

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.

Motivational Interviewing (MI)behavioral

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.

Education (ED)behavioral

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.