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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD041490 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom-Fitted Lightweight Wheelchair & Cushion | Experimental | Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training |
|
| Cushion Only | Other | Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lightweight wheelchair | Device | Seating and wheeled mobility assessment and fitting of a lightweight wheelchair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Brienza, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21070197 | Background | 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. | |
| 30094810 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Custom-Fitted Lightweight Wheelchair & Cushion | 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 |
| FG001 | Cushion Only | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Custom-Fitted Lightweight Wheelchair & Cushion | 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 |
| BG001 | Cushion Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 182 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Custom-Fitted Lightweight Wheelchair & Cushion | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Brienza, Professor | University of Pittsburgh | 412-624-6383 | DBRIENZA@pitt.edu |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
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| Skin Protection Cushion | Device | Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Incontinent | Count of Participants | Participants |
|
| Previous history of pressure injury | Count of Participants | Participants |
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| Patient alert and oriented | Count of Participants | Participants |
|
| Ambulation Distance | Count of Participants | Participants |
|
| Sensation | Count of Participants | Participants |
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| Scoliosis | Count of Participants | Participants |
|
| Kyphosis | Count of Participants | Participants |
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| Lordosis | Count of Participants | Participants |
|
| Pelvic tilt | Count of Participants | Participants |
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| Pelvic Rotation | Count of Participants | Participants |
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| Pelvic Obliquity | Count of Participants | Participants |
|
|
|
|
| 8 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | Cushion Only | 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 | 5 | 131 | 0 | 131 | 0 | 131 |
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| D017437 | Skin and Connective Tissue Diseases |