Pressure Ulcer Prevention Study in SCI (PUPS)

October 26, 2016 updated by: Florence Clark, University of Southern California

Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Downey, California, United States, 90242
        • Rancho Los Amigos National Rehabilitation Center (RLANRC)
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 ulcer prevention.
  • 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 Criteria:

  • Present serious stage 4 pressure ulcer
  • Participation in our preliminary research studies
  • Participating in the neuromuscular stimulation study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Experimental: Lifestyle Redesign
Occupational therapist led lifestyle redesign program to prevent pressure ulcers
Behavioral: Lifestyle Redesign
Individualized program for lifestyle redesign aimed at decreasing the risk of medically serious pressure ulcers led by licensed occupational therapists trained in the implementation of the lifestyle redesign program
Other Names:
  • Occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious pressure ulcers
Time Frame: Throughout 12-month study intervention
New stage 3 or 4 pressure ulcers
Throughout 12-month study intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ulcer related surgeries
Time Frame: Throughout 12-month study intervention and 12-months post intervention period
Surgical wound repair (flap, skin graft, girdlestone, other)
Throughout 12-month study intervention and 12-months post intervention period
Quality of life
Time Frame: Throughout 12-month study intervention and 12-months post intervention period
Measured by the Medical Outcomes Study Short Form (SF-36)
Throughout 12-month study intervention and 12-months post intervention period
Healthcare service utilization
Time Frame: Throughout 12-month study intervention and 12-months post intervention period
Estimated cost of healthcare services including inpatient, outpatient, ER, home healthcare, lab, imaging, etc.
Throughout 12-month study intervention and 12-months post intervention period
Incidence of serious pressure ulcers
Time Frame: Throughout 12-months post intervention period
New stage 3 or 4 pressure ulcers during the second study year
Throughout 12-months post intervention period
Life Satisfaction
Time Frame: Throughout 12-month study intervention and 12-months post intervention period
Measured by the Satisfaction with Life Scale (SWLS)
Throughout 12-month study intervention and 12-months post intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Florence Clark, PhD, University of Southern California
  • Principal Investigator: Salah Rubayi, MD, Rancho Los Amigos National Rehabilitation Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

November 25, 2013

First Posted (Estimate)

December 3, 2013

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-06-00064
  • R01HD056267 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will submit de-identified data to ICPSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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