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Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study (WOUND)

This study has been completed.
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Dianne Bryant, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00796042
First received: November 21, 2008
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

People with spinal cord injuries posses many factors that increase their risk of developing pressure ulcers. Not surprisingly, approximately 82% of persons with spinal cord injury (SCI) will experience a pressure ulcer at sometime during their life. Earlier guidelines for the assessment and treatment of pressure ulcers produced by RNAO in 20027 recommended that "a client who has a pressure ulcer on a seating surface should avoid sitting." Unfortunately, this recommendation has fueled the long standing view that people with pressure ulcers should stop using their wheelchairs and return to bed. The strength of evidence assigned for this recommendation was Level=C reflecting the paucity of research evidence to support this common practice. Not only do the benefits of bed rest on healing remain to be demonstrated, there is mounting evidence that bed rest can be harmful to a person's overall health and well being. Bed rest has been shown to be strongly associated with complications in most body systems including respiratory, cardiovascular, musculoskeletal, cerebrovascular, gastrointestinal, and genital-urinary. Psychosocial complications and cognitive impacts are also well documented. Without evidence to dispel the myth that "bed rest is best" it will be difficult to change practice and avoid many of the secondary complications. This study is a pilot study to 1) determine whether pressure ulcers heal faster in individuals with SCI who receive an individualized community-based, pressure management and mobility program compared to a similar group assigned to usual care (bed rest), 2) determine the strength of the association between the intervention (pressure/mobility or bedrest) and wound healing, motor performance/independence and quality of life while adjusting for motivation to regain independence, degree of caregiver burden, and compliance with the intervention, 3) determine whether individuals with SCI who participate in a pressure/mobility management program experience fewer secondary complications than those who do not participate, 4) determine the cost-effectiveness of providing a time-efficient, pressure management and mobility program compared to bed rest.


Condition Intervention Phase
Pressure Ulcer
Other: Usual care
Other: Pressure management and Mobility program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interdisciplinary Pressure Management & Mobility Program as an Alternative to Bed Rest: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Wound healing: We will measure changes in wound size and appearance using acetate tracings with Visatrak system, digital photography, and the Photographic wound assessment tool (PWAT). [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost Effectiveness [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Quality of Life (SF-12 and Cardiff Wound Impact Questionnaire) [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Motor Performance (Canadian Occupational Performance Measure (COPM)), [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Secondary complications [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Caregiver Burden [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]
  • Compliance (diary) [ Time Frame: monthly to 8 months post intervention ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Usual Care
Other: Usual care
Subjects will be encouraged to implement the standard wound care protocol that is consistent with the National (CAWC) and Provincial (RNAO) best practice guidelines for the treatment of pressures ulcers. This wound care program will be customized to subject's needs based on the results of the assessment performed by the wound care specialist. A registered dietitian will review blood values associated with nutritional status and make recommendations for dietary changes. Wherever possible, implementation of this wound care program will be coordinated with the subjects' current health care team and appropriate referrals to home care agencies or specialists will be initiated where needed. Subjects assigned to this group will continue their current level of activity (bed rest). Any equipment or services will be obtained through the usual provider agencies.
Experimental: 2
Individualized, Community-based, Pressure management and Mobility program:
Other: Pressure management and Mobility program
Subjects are provided with the same customized wound care program as the usual care group and a pressure management and mobility program that is customized to the individual's needs. This program is based on an in depth home assessment performed by a registered Occupational (OT) or Physical Therapist (PT). Pressure Management Program: A qualified OT or PT will examine the subject on all in-use surfaces and observe all transfers to identify sources of friction and shear, and any strength or balance deficits, identifying what equipment/services are required to manage pressure, improve mobility, and reduce friction and shear. Mobility Program: A qualified PT will assess strength, balance, range of motion, and functional independence with transfers and other ADLs and will develop a mobility program to optimize functional independence and improve strength and balance required for safe and effective transfers. Program to be implemented within one month of this evaluation.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18-80 yrs) with a spinal cord injury (SCI) resulting in quadriplegia or paraplegia
  • Stage II-IV pressure ulcer located anywhere on the body that is likely to heal over the 6 month study period.
  • Requires a wheelchair for locomotion
  • Able to travel to local wound centre to undergo detailed wound and medical assessment that includes blood analysis and wound culture.
  • Provides consent to access relevant medical records.
  • Able to adhere with study protocol, pressure management and mobility program, wound care protocol, and evaluation procedures for 8 month study period.

Exclusion Criteria:

  • Unable to achieve adequate pressure relief using available resources provided by research study.
  • Stage IV deep pressure sore +/- osteomyelitis that requires surgical closure.
  • Medically unstable or has or any other medical condition that would prevent the individual from sitting in wheelchair for at least 2 hours (e.g. Orthostatic hypotension).
  • Has a limited life expectancy that is not sufficient to complete the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796042

Locations
Canada, Ontario
University of Western Ontario
London, Ontario, Canada
Women's College Hospital & Mississauga Dermatology Clinic
Toronto & Mississauga, Ontario, Canada
Sponsors and Collaborators
University of Western Ontario, Canada
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Pamela Houghton, BScPT, PhD University of Western Ontario, Canada
Principal Investigator: Linda Norton, OT (Reg) Shoppers Home Health Care
  More Information

No publications provided

Responsible Party: Dianne Bryant, Associate Professor, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00796042     History of Changes
Obsolete Identifiers: NCT00569205
Other Study ID Numbers: ONF-2004-SCI-SC-01, ONF-2004-SCI-SC-01
Study First Received: November 21, 2008
Last Updated: June 4, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by University of Western Ontario, Canada:
Pressure Ulcer
Bed Sores
Bedsore
Decubitus Ulcer
Pressure Sore
Best rest
mobility
pressure management

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014