RCT-WC2: Wheeled Mobility for Preventing Pressure Ulcers

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01275313
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 258
• Location: 1
• Arms: 2
• Duration (Months): 50.1
• Patients Per Site Per Month: 5.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mobility Limitation	Device: Lightweight wheelchair; Device: Skin Protection Cushion	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: RCT on Wheeled Mobility for Preventing Pressure Ulcers
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jun 5, 2015
• Actual Study Completion Date: Jun 5, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of a Sitting-induced Pressure Ulcer [182 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15206

Sponsors and Collaborators

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

Investigators

• Principal Investigator: David Brienza, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: David Brienza, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01275313
• Other Study ID Numbers: PRO09120362; R01HD041490
• First Posted: Jan 12, 2011
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by David Brienza, Professor, University of Pittsburgh: Pressure ulcers; wheelchairs; wheelchair functional capacity; custom-fitted wheelchair
• Additional relevant MeSH terms: Pressure Ulcer; Mobility Limitation

Study Results

Participant Flow

Arm/Group Title	Custom-Fitted Lightweight Wheelchair & Cushion	Cushion Only
Arm/Group Description	Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair	Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
Period Title: Overall Study
STARTED	127	131
COMPLETED	102	79
NOT COMPLETED	25	52

Baseline Characteristics

Arm/Group Title	Custom-Fitted Lightweight Wheelchair & Cushion	Cushion Only	Total
Arm/Group Description	Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair	Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion	Total of all reporting groups
Overall Participants	127	131	258
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	89.0 (8.7)	89.1 (9.2)	89.0 (8.9)
Sex: Female, Male (Count of Participants)
Female	97 76.4%	105 80.2%	202 78.3%
Male	30 23.6%	26 19.8%	56 21.7%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.0 (5.2)	26.9 (5.8)	26.5 (5.5)
Incontinent (Count of Participants)
Count of Participants [Participants]	102 80.3%	95 72.5%	197 76.4%
Previous history of pressure injury (Count of Participants)
Count of Participants [Participants]	27 21.3%	17 13%	44 17.1%
Patient alert and oriented (Count of Participants)
Count of Participants [Participants]	114 89.8%	116 88.5%	230 89.1%
Ambulation Distance (Count of Participants)
0 ft	63 49.6%	77 58.8%	140 54.3%
<= 10 ft	28 22%	22 16.8%	50 19.4%
>10 ft	36 28.3%	31 23.7%	67 26%
Unknown	0 0%	1 0.8%	1 0.4%
Sensation (Count of Participants)
Normal	96 75.6%	88 67.2%	184 71.3%
Diminished/Questionable	26 20.5%	31 23.7%	57 22.1%
Absent	1 0.8%	0 0%	1 0.4%
Unknown	4 3.1%	12 9.2%	16 6.2%
Scoliosis (Count of Participants)
Neutral	89 70.1%	83 63.4%	172 66.7%
Flex deformity	23 18.1%	23 17.6%	46 17.8%
Fixed deformity	11 8.7%	13 9.9%	24 9.3%
Unknown	4 3.1%	12 9.2%	16 6.2%
Kyphosis (Count of Participants)
Neutral	26 20.5%	26 19.8%	52 20.2%
Flex deformity	65 51.2%	64 48.9%	129 50%
Fixed deformity	32 25.2%	29 22.1%	61 23.6%
Unknown	4 3.1%	12 9.2%	16 6.2%
Lordosis (Count of Participants)
Neutral	123 96.9%	119 90.8%	242 93.8%
Unknown	4 3.1%	12 9.2%	16 6.2%
Pelvic tilt (Count of Participants)
Neutral	32 25.2%	35 26.7%	67 26%
Flex deformity	64 50.4%	62 47.3%	126 48.8%
Fixed deformity	27 21.3%	22 16.8%	49 19%
Unknown	4 3.1%	12 9.2%	16 6.2%
Pelvic Rotation (Count of Participants)
Neutral	97 76.4%	87 66.4%	184 71.3%
Flex deformity	24 18.9%	28 21.4%	52 20.2%
Fixed deformity	2 1.6%	4 3.1%	6 2.3%
Unknown	4 3.1%	12 9.2%	16 6.2%
Pelvic Obliquity (Count of Participants)
Neutral	102 80.3%	93 71%	195 75.6%
Flex deformity	18 14.2%	21 16%	39 15.1%
fixed deformity	3 2.4%	5 3.8%	8 3.1%
Unknown	4 3.1%	12 9.2%	16 6.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Custom-Fitted Lightweight Wheelchair & Cushion	Cushion Only
Arm/Group Description	Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair	Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
Measure Participants	102	89
Seating surface pressure injury	19 15%	15 11.5%
26 weeks since initiation of seating intervention	75 59.1%	69 52.7%
Death	8 6.3%	5 3.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Custom-Fitted Lightweight Wheelchair & Cushion, Cushion Only
	Comments	Null hypothesis: At-risk nursing home residents provided with an individually-configured manual lightweight wheelchair and skin protection cushion have the same incidence of pressure injury development compared to individuals using a facility-provided manual wheelchair modified with a skin protection cushion and related adjustments.
	Type of Statistical Test	Equivalence
	Comments	Power calculation: To determine a difference of 20% in the control group and 10% in the treatment group with 80% power, 440 participants would be needed.
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	Chi-squared, Corrected
	Comments

Adverse Events

Arm/Group Title	Custom-Fitted Lightweight Wheelchair & Cushion		Cushion Only
Arm/Group Description	Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair		Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
All Cause Mortality
	Custom-Fitted Lightweight Wheelchair & Cushion		Cushion Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/127 (6.3%)		5/131 (3.8%)
Serious Adverse Events
	Custom-Fitted Lightweight Wheelchair & Cushion		Cushion Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/131 (0%)
Other (Not Including Serious) Adverse Events
	Custom-Fitted Lightweight Wheelchair & Cushion		Cushion Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/131 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.