Wheeled Mobility for Preventing Pressure Ulcers (RCT-WC2)

RCT on Wheeled Mobility for Preventing Pressure Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Mobility Limitation
• Intervention / Treatment: Device: Lightweight wheelchair; Device: Skin Protection 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.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of a Sitting-induced Pressure Ulcer	Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days	182 days

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: David Brienza, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• Brienza D, Kelsey S, Karg P, Allegretti A, Olson M, Schmeler M, Zanca J, Geyer MJ, Kusturiss M, Holm M. A randomized clinical trial on preventing pressure ulcers with wheelchair seat cushions. J Am Geriatr Soc. 2010 Dec;58(12):2308-14. doi: 10.1111/j.1532-5415.2010.03168.x. Epub 2010 Nov 10.
• Brienza DM, Karg PE, Bertolet M, Schmeler M, Poojary-Mazzotta P, Vlachos H, Wilkinson D. A Randomized Clinical Trial of Wheeled Mobility for Pressure Injury Prevention and Better Function. J Am Geriatr Soc. 2018 Sep;66(9):1752-1759. doi: 10.1111/jgs.15495. Epub 2018 Aug 10.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): June 5, 2015
• Study Completion (ACTUAL): June 5, 2015

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (ESTIMATE): January 12, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pressure ulcers; wheelchairs; wheelchair functional capacity; custom-fitted wheelchair
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Mobility Limitation; Pressure Ulcer
• Other Study ID Numbers: PRO09120362; R01HD041490 (NIH)