NCT01275313

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 9, 2017

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

4.2 years

First QC Date

January 10, 2011

Results QC Date

May 23, 2017

Last Update Submit

June 2, 2022

Conditions

Mobility Limitation

Keywords

Pressure ulcerswheelchairswheelchair functional capacitycustom-fitted wheelchair

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Custom-Fitted Lightweight Wheelchair & Cushion

EXPERIMENTAL

Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training

Device: Lightweight wheelchair

Cushion Only

OTHER

Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair

Device: Skin Protection Cushion

Interventions

Lightweight wheelchairDEVICE

Seating and wheeled mobility assessment and fitting of a lightweight wheelchair

Custom-Fitted Lightweight Wheelchair & Cushion
Skin Protection CushionDEVICE

Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion

Cushion Only

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Body weight exceeding 250 lbs.
  • Hip width exceeding 20 in.
  • 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.
  • 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)
  • Current use of a HCPCS code K0004 wheelchair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

Related Publications (2)

  • 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.

    PMID: 21070197BACKGROUND

  • 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.

    PMID: 30094810DERIVED

MeSH Terms

Conditions

Mobility LimitationPressure Ulcer

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
David Brienza, Professor
Organization
University of Pittsburgh
DBRIENZA@pitt.edu
412-624-6383

Study Officials

  • David Brienza, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 12, 2011

Study Start

April 1, 2011

Primary Completion

June 5, 2015

Study Completion

June 5, 2015

Last Updated

June 28, 2022

Results First Posted

June 9, 2017

Record last verified: 2022-06

Locations

US(1)