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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00763282
First received: September 26, 2008
Last updated: April 6, 2015
Last verified: October 2014

September 26, 2008
April 6, 2015
November 2008
June 2011   (final data collection date for primary outcome measure)
  • Percent of Possible Self-Reported Skin Care Behaviors [ Time Frame: Admission (Baseline), 3 months, 6 months ] [ Designated as safety issue: No ]

    Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline).

    The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge.

  • Skin Behavior Change [ Time Frame: Admission (Baseline), 3 months, 6 months ] [ Designated as safety issue: No ]

    Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms.

    The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge.

  • Any Skin Worsening [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
  • Skin Status [ Time Frame: Admission (Baseline), 3 months, 6 months ] [ Designated as safety issue: No ]
    Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
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 ]
Complete list of historical versions of study NCT00763282 on ClinicalTrials.gov Archive Site
Mean Number of Skin-related Admissions [ Time Frame: Discharge to end of study (6 months) ] [ Designated as safety issue: Yes ]
Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.
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Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury
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.

Background:

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 2010 was just under $400 million.

Objectives:

The primary objective of this randomized clinical trial (RCT) was to determine whether a multi-component self-management (SM) intervention increases the use of skin-protective behaviors and reduces skin worsening in Veterans with SCI, compared to an education control (ED) intervention. Secondary outcomes included PrU knowledge, self-management skills, communication with providers, self-efficacy, community integration and days on bedrest. Another objective was to conduct focus group interviews with patients and providers and to analyze transcripts of SM group sessions to determine barriers and facilitators with regard to spinal cord injury and pressure ulcer prevention.

Methods:

This was a multi-site efficacy intervention study with a single blind prospective randomized design. Descriptive statistics were used to summarize demographic and key variables. Supplemental focus group interviews were conducted with patients with SCI (n=35) and SCI providers (n=39). Focus group interviews and SM group calls were transcribed verbatim and analyzed using constant comparative techniques.

Study participants included Veterans hospitalized for Stage III/IV PrUs at or below the level of injury, from six VA SCI Centers around the country (Long Beach, Houston, Milwaukee, Augusta, Hines and St. Louis). Prior to discharge, PrU risk factors were identified and 1:1 PrU education was provided. Randomization and the behavioral interventions began at discharge. The number of randomized subjects were 72 in the ED group and 72 in the SM group (n=144). The analytic sample included subjects with complete data (n=92).

The intervention included 8 site coordinator-initiated calls using didactic (ED) or Motivational Interviewing (MI) strategies to address PrU risk factors. The second component included telephone group calls that included either didactic information about SCI or SM skills including: 1) knowledge about the medical condition; 2) self-monitoring; 3) problem-solving skills; 4) skill for managing the effects of the condition; 5) adherence to necessary health behaviors; and 6) self-advocacy with health care providers. ED subjects received general health information and were not instructed in any specific problem solving, self-monitoring or SM techniques. The ED intervention was comparable to the SM with respect to natural history/ time, dosing, measurement processes, attention, therapeutic alliance, social support, and in receiving a manualized treatment with specific therapist procedures. Self-reported outcome data were obtained by phone at 3 and 6 months, and from mailed photos of study ulcers.

Status:

Study is complete. Additional analyses are ongoing and future manuscripts are planned.

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 MI to support ongoing self-management activities, and 5) distance technology.
  • Behavioral: Motivational Interviewing (MI)
    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.
  • Behavioral: Education (ED)
    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.
  • Experimental: SM+MI
    Self Management (SM) + Motivational Interviewing (MI). Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. Motivational Interviewing (MI) is an evidence-based form of counseling to help individuals to engage in behavior change. 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.
    Interventions:
    • Behavioral: Self Management (SM)
    • Behavioral: Motivational Interviewing (MI)
  • Active Comparator: ED
    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.
    Intervention: Behavioral: Education (ED)
Guihan M, Bombardier CH, Ehde DM, Rapacki LM, Rogers TJ, Bates-Jensen B, Thomas FP, Parachuri R, Holmes SA. Comparing multicomponent interventions to improve skin care behaviors and prevent recurrence in veterans hospitalized for severe pressure ulcers. Arch Phys Med Rehabil. 2014 Jul;95(7):1246-1253.e3. doi: 10.1016/j.apmr.2014.01.012. Epub 2014 Jan 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
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:

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.

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00763282
IIR 06-203
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Marylou Guihan, PhD MA BA Edward Hines Jr. VA Hospital, Hines, IL
VA Office of Research and Development
October 2014

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