Wheeled Mobility for Preventing Pressure Ulcers

NCT ID: NCT01275313

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-06-05

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.

Conditions

Mobility Limitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Custom-Fitted Lightweight Wheelchair & Cushion

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

Group Type: EXPERIMENTAL

Lightweight wheelchair

Intervention Type: DEVICE

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

Group Type: OTHER

Skin Protection Cushion

Intervention Type: DEVICE

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

Interventions

Lightweight wheelchair

Seating and wheeled mobility assessment and fitting of a lightweight wheelchair

Intervention Type: DEVICE

Skin Protection Cushion

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

David Brienza

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Brienza, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21070197 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30094810 (View on PubMed)

Other Identifiers

R01HD041490

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO09120362

Identifier Type: -

Identifier Source: org_study_id