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

NCT00796042 | Completed Phase 3

• 1 other identifier: ONF-2004-SCI-SC-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer; Bed Sores; Bedsore; Decubitus Ulcer; Pressure Sore; Best rest; mobility; pressure management

Outcome Measures

Primary Outcomes (1)

• 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).

  monthly to 8 months post intervention

Secondary Outcomes (6)

• Cost Effectiveness

  monthly to 8 months post intervention

• Quality of Life (SF-12 and Cardiff Wound Impact Questionnaire)

  monthly to 8 months post intervention

• Motor Performance (Canadian Occupational Performance Measure (COPM)),

  monthly to 8 months post intervention

• Secondary complications

  monthly to 8 months post intervention

• Caregiver Burden

  monthly to 8 months post intervention

Study Arms (2)

1

ACTIVE COMPARATOR

Usual Care

Other: Usual care

2

EXPERIMENTAL

Individualized, Community-based, Pressure management and Mobility program:

Other: Pressure management and Mobility program

Interventions

Usual care OTHER

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.

1

Pressure management and Mobility program OTHER

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.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Western Ontario, Canada: lead
• Ontario Neurotrauma Foundation: collaborator

Study Sites (2)

University of Western Ontario

London, Ontario, Canada

Location

Women's College Hospital & Mississauga Dermatology Clinic

Toronto & Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pamela Houghton, BScPT, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

• Linda Norton, OT (Reg)

  Shoppers Home Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CA (2)