Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Trial on Wheeled Mobility for Preventing Pressure Ulcers (RCT-WC2)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
David Brienza, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01275313
First received: January 10, 2011
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they are common in nursing home settings because their causes are difficult to identify. This clinical trial will guide practitioners toward improving preventive care practices by demonstrating how to effectively apply wheelchair and seat cushion technology.

Condition Intervention Phase
Mobility Limitation
Device: Lightweight wheelchair
Device: Skin Protection Cushion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RCT on Wheeled Mobility for Preventing Pressure Ulcers

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Incidence of a sitting-induced pressure ulcer [ Time Frame: 182 days ] [ Designated as safety issue: No ]
    Skin assessments for incidence of sitting-induced pressure ulcer will occur once per week until occurrence of a pressure ulcer or 180 days


Secondary Outcome Measures:
  • Functional capacity [ Time Frame: 182 days ] [ Designated as safety issue: No ]
    Functional capacity will be assessed using the Functioning Everyday with a Wheelchair-Capacity (FEW-C) tool at baseline, after intervention and at study endpoint (pressure ulcer or 182 days)


Enrollment: 256
Study Start Date: April 2011
Study Completion Date: June 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Custom-Fitted Lightweight Wheelchair & Cushion
Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Device: Lightweight wheelchair
Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
Cushion Only
Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Device: Skin Protection Cushion
Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion

Detailed Description:
Pressure ulcers are a significant healthcare problem for the growing number of nursing home residents in the United States and around the world. Pressure ulcers diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs. Costs for the management of pressure ulcers in the US likely exceeds $6.4 billion annually, with a prevalence of approximately 12% in the high risk LTC population. A previous clinical trial at the University of Pittsburgh studied the effects of seat cushions on pressure ulcer incidence and found that when a skin protection seat cushion is used with a properly fitted wheelchair there is a significant reduction in incidence. The data led the investigators to question whether having a properly fitted wheelchair also has a significant effect on pressure ulcer incidence. This clinical trial investigate this question by randomizing subjects into a control group that receives a skin protection cushion and wheelchair training for use in their facility supplied wheelchair, or a treatment group that receives a skin protection cushion, wheelchair training and a new custom-fitted wheelchair. We expect that the treatment group will have a lower incidence of pressure ulcers.
  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female nursing home resident 60 years of age and older
  2. A Braden score of less than or equal to 18
  3. A combined Braden Activity and Mobility Subscale score less than or equal to 5
  4. Absence of ischial and sacral area pressure ulcers (see definition of pressure ulcer)
  5. A tolerance for total daily wheelchair sitting time of greater than or equal to 6 hours (not continuous)
  6. Ability to accommodate seating and positioning needs with the wheelchair selected for use in this study (Breezy Ultra 4)
  7. Informed written consent

Exclusion Criteria:

  1. Body weight exceeding 250 lbs.
  2. Hip width exceeding 20 in.
  3. Wheelchair seating requirements for additional head support, seat depth > 20 inches, elevated leg rests or severe orthopedic deformities of the pelvis, lower extremities or back that exceed the accommodating capability of the Breezy Ultra 4 wheelchair.
  4. Current use of any cushioning material(s) other than a standard cushion, a folded pad, or a pillow (standard cushion as defined by HCPCS code for Standard Cushions, i.e., non-skin protection cushion)
  5. Current use of a HCPCS code K0004 wheelchair
  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: NCT01275313

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: David Brienza, PhD University of Pittsburgh
  More Information

Publications:
Responsible Party: David Brienza, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01275313     History of Changes
Other Study ID Numbers: PRO09120362  R01HD041490 
Study First Received: January 10, 2011
Last Updated: August 31, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Pressure ulcers
wheelchairs
wheelchair functional capacity
custom-fitted wheelchair

Additional relevant MeSH terms:
Pressure Ulcer
Mobility Limitation
Skin Ulcer
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016