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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00763282
First received: September 26, 2008
Last updated: April 15, 2014
Last verified: April 2014

September 26, 2008
April 15, 2014
November 2008
June 2011   (final data collection date for primary outcome measure)
1) Self-efficacy (use of skin protective behaviors), 2) Skin worsening/development of new pressure ulcer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00763282 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury

The major objective of this randomized control trial is to determine whether a multi-component self-management intervention can increase the use of skin-protective behaviors in veterans with SCI. We will also determine whether improvements in skin care behaviors prevent or delay PrU recurrence.

Expected Contribution to the VA and Others: Lack of sensation and immobility increase risk of pressure ulcers (PrUs) in SCI, making them a serious, costly, and life-long complication for veterans with SCI. Prevention and/or early detection and reporting of PrUs in the community-dwelling SCI population is important because: SCI is the most costly medical condition in VA; PrUs cause morbidity and mortality in the SCI population; everyone with SCI is at risk of developing ulcers; and little empirical evidence exists to guide prevention/treatment of PrUs in this population. Reducing the prevalence of PrUs in SCI will have a significant impact on the VA's financial and resources. The study's long-term objective is to implement effective, consistent, and cost-effective PrU prevention protocols into routine clinical practice within VHA, enhancing veterans' general health and quality of life by reducing the need for costly hospitalizations and PrU surgery.

Objectives: The primary objective of this study is to determine whether a multi-component self-management (SM) intervention increases the use of skin-protective behaviors and reduce skin worsening in veterans with SCI. The SM intervention 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 motivational interviewing to support ongoing self-management activities, and 5) distance technology. 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. This project focuses on improving patient behavior and making health system changes.

Methods:

Research Design: A randomized prospective multi-site, pre-test/post-test design.

Population: Veterans hospitalized for Stage III/IV pelvic PrUs from 6 VA SCI Centers. Participants must be >18 years, >6 months post-SCI, cognitively intact, reside in the community and oversee their own skin care.

Sources of Data: Patient demographic information measures of pressure ulcer knowledge, skin management needs assessment, readiness-to-change SM behaviors (symptom management, communication with providers, cognitive symptom management, etc.), and self-efficacy will be collect at 0, 3 and 6 months, Medical diagnosis, treatment and utilization information will be obtained from VA administrative data. Digital photos will be used to verify patient self-reported skin status.

Analysis: The primary outcomes of this study are: 1) increased use of skin-protective behaviors and 2) skin worsening outcomes (e.g., recurrence/new skin breakdown, median time to skin worsening,). Secondary objectives include: days in bed due to skin problems, severity of the recurrence/new skin breakdown, and hospital days due to skin problems; PrU knowledge, skin care self-efficacy, community integration/ participation and perceived quality of life. Multivariate and Cox proportional hazards regression models will be used to examine study outcomes.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Pressure Ulcers
  • Spinal Cord Injuries
  • Behavioral: Self Management (SM)
    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 motivational interviewing to support ongoing self-management activities, and 5) distance technology.
  • Behavioral: Education (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.
  • Experimental: Arm 1
    Self Management (SM)
    Intervention: Behavioral: Self Management (SM)
  • Active Comparator: Arm 2
    Education (ED)
    Intervention: Behavioral: Education (ED)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 2011
June 2011   (final data collection date for primary outcome measure)

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:

  • significant psychiatric co-morbidities (e.g., schizophrenia and other active psychoses), or
  • terminal diagnosis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00763282
IIR 06-203
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Marylou Guihan, PhD MA BA Edward Hines Jr. VA Hospital
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP