Pressure Ulcer Prevention Study in SCI

Last updated: October 26, 2016
Sponsor: University of Southern California
Overall Status: Completed

Phase

3

Condition

Spinal Cord Injuries

Pressure Ulcer

Treatment

N/A

Clinical Study ID

NCT01999816
HS-06-00064
R01HD056267
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the intervention's cost-effectiveness and potential cost savings and its effects on participants' quality of life.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Spinal cord injury (paraplegia or tetraplegia)

  • Non-ambulatory

  • Able to undergo intervention and testing in English or Spanish

  • At least 6 months post-injury

  • History of at least one serious (Stage 3 or 4) pressure ulcer in the past 5 years

  • Cognitively intact

  • Personally expressed willingness to undertake recommended lifestyle changes for ulcerprevention.

  • Can be reached by telephone.

  • Reside in or within 100 miles of Rancho Los Amigos National Rehabilitation Center (Downey, CA) with no plans to relocate beyond this area.

  • Agreement to participate and completion of consent form.

Exclusion

Exclusion Criteria:

  • Present serious stage 4 pressure ulcer

  • Participation in our preliminary research studies

  • Participating in the neuromuscular stimulation study

Study Design

Total Participants: 170
Study Start date:
September 01, 2008
Estimated Completion Date:
September 30, 2015

Study Description

Medically serious pressure ulcers are a common complication of spinal cord injury (SCI), and are associated with high treatment costs and reduced quality of life. This study will examine the efficacy and cost-effectiveness of a promising lifestyle-based intervention designed to reduce the incidence of pressure ulcers among culturally diverse, community dwelling adults with SCI who have had serious pressure ulcers.

The intervention being tested, termed lifestyle redesign (LR), is based on prior SCI literature as well as on the results of a qualitative pilot study undertaken by our study group. This intervention targets several psychosocial mediating variables that have been shown to be important in prevention of pressure ulcers in daily living contexts. Participants assigned to the LR condition receive individualized in-home sessions, personal phone calls, and incident-based contacts for a 12-month period, followed by 12 months of no intervention. Participants in the control condition do not receive any study-based intervention, but (along with the LR group) have continuing access to the standard options for prevention and treatment that are available through Rancho Los Amigos National Rehabilitation Center.

In addition to identifying a pressure ulcer prevention strategy, the planned research will lead to the development of testable theoretical models of the intervening process mechanisms that link the intervention to pressure ulcer reduction.

Connect with a study center

  • Rancho Los Amigos National Rehabilitation Center (RLANRC)

    Downey, California 90242
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

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