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
  Purpose

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.


Condition Intervention
Pressure Ulcers
Spinal Cord Injuries
Behavioral: Self Management (SM)
Behavioral: Education (ED)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Enrollment: 400
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Self Management (SM)
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.
Active Comparator: Arm 2
Education (ED)
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • significant psychiatric co-morbidities (e.g., schizophrenia and other active psychoses), or
  • terminal diagnosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763282

Locations
United States, California
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
United States, Wisconsin
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Investigators
Principal Investigator: Marylou Guihan, PhD MA BA Edward Hines Jr. VA Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00763282     History of Changes
Other Study ID Numbers: IIR 06-203
Study First Received: September 26, 2008
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Spinal cord injuries
Pressure ulcers

Additional relevant MeSH terms:
Spinal Cord Injuries
Ulcer
Pressure Ulcer
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014