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Wheeled Mobility for Preventing Pressure Ulcers (RCT-WC2)

Primary Purpose

Mobility Limitation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lightweight wheelchair

Skin Protection Cushion

About this trial

This is an interventional prevention trial for Mobility Limitation focused on measuring Pressure ulcers, wheelchairs, wheelchair functional capacity, custom-fitted wheelchair

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Custom-Fitted Lightweight Wheelchair & Cushion

Cushion Only

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01275313

First Posted

January 10, 2011

Last Updated

June 2, 2022

Sponsor

University of Pittsburgh

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT01275313

Brief Title

Wheeled Mobility for Preventing Pressure Ulcers

Acronym

RCT-WC2

Official Title

RCT on Wheeled Mobility for Preventing Pressure Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

June 5, 2015 (Actual)

Study Completion Date

June 5, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mobility Limitation

Keywords

Pressure ulcers, wheelchairs, wheelchair functional capacity, custom-fitted wheelchair

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

258 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Custom-Fitted Lightweight Wheelchair & Cushion

Arm Type

Experimental

Arm Description

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

Arm Title

Cushion Only

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Lightweight wheelchair

Intervention Description

Seating and wheeled mobility assessment and fitting of a lightweight wheelchair

Intervention Type

Device

Intervention Name(s)

Skin Protection Cushion

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of a Sitting-induced Pressure Ulcer

Description

Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days

Time Frame

182 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Brienza, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21070197

Citation

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.

Results Reference

background

PubMed Identifier

30094810

Citation

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.

Results Reference

derived

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Wheeled Mobility for Preventing Pressure Ulcers

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