Clinical trial NCT01275313: Wheeled Mobility for Preventing Pressure Ulcers
Official title: RCT on Wheeled Mobility for Preventing Pressure Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Keywords: Pressure ulcers
wheelchairs
wheelchair functional capacity
custom-fitted wheelchair
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-01-12
Enrollment: 258
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of a Sitting-induced Pressure Ulcer
timeFrame: 182 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David Brienza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.