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Completed

NCT Number: NCT01999816

Pressure Ulcer Prevention Study in SCI

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rancho Los Amigos National Rehabilitation Center (RLANRC), Downey, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Redesign

Behavioral

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

Primary outcomes

  1. Incidence of serious pressure ulcers

    Time frame: Throughout 12-month study intervention

    New stage 3 or 4 pressure ulcers

Secondary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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

  5. Life Satisfaction

    Time frame: Throughout 12-month study intervention and 12-months post intervention period

    Measured by the Satisfaction with Life Scale (SWLS)

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

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

Registry information

Official study title

Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury

Acronym: PUPS

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2013
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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