Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| 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, Illinois, United States, 60141-3030 | |
| 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 | |
| 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: | January 24, 2013 |
| 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 Pressure Ulcer Ulcer Skin Ulcer Skin Diseases Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013