Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
170 participants
INTERVENTIONAL
2008-09-30
2015-09-30
Brief Summary
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Detailed Description
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The intervention being tested, termed lifestyle redesign (LR), is based on prior SCI literature as well as on the results of a qualitative pilot study undertaken by our study group. This intervention targets several psychosocial mediating variables that have been shown to be important in prevention of pressure ulcers in daily living contexts. Participants assigned to the LR condition receive individualized in-home sessions, personal phone calls, and incident-based contacts for a 12-month period, followed by 12 months of no intervention. Participants in the control condition do not receive any study-based intervention, but (along with the LR group) have continuing access to the standard options for prevention and treatment that are available through Rancho Los Amigos National Rehabilitation Center.
In addition to identifying a pressure ulcer prevention strategy, the planned research will lead to the development of testable theoretical models of the intervening process mechanisms that link the intervention to pressure ulcer reduction.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Lifestyle Redesign
Occupational therapist led lifestyle redesign program to prevent pressure ulcers
Lifestyle Redesign
Individualized program for lifestyle redesign aimed at decreasing the risk of medically serious pressure ulcers led by licensed occupational therapists trained in the implementation of the lifestyle redesign program
Control
Usual care
No interventions assigned to this group
Interventions
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Lifestyle Redesign
Individualized program for lifestyle redesign aimed at decreasing the risk of medically serious pressure ulcers led by licensed occupational therapists trained in the implementation of the lifestyle redesign program
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-ambulatory
* Able to undergo intervention and testing in English or Spanish
* At least 6 months post-injury
* History of at least one serious (Stage 3 or 4) pressure ulcer in the past 5 years
* Cognitively intact
* Personally expressed willingness to undertake recommended lifestyle changes for ulcer prevention.
* Can be reached by telephone.
* Reside in or within 100 miles of Rancho Los Amigos National Rehabilitation Center (Downey, CA) with no plans to relocate beyond this area.
* Agreement to participate and completion of consent form.
Exclusion Criteria
* Participation in our preliminary research studies
* Participating in the neuromuscular stimulation study
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Southern California
OTHER
Responsible Party
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Florence Clark
Associate Dean, Chair, and Professor Occupational Science and Occupational Therapy
Principal Investigators
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Florence Clark, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Salah Rubayi, MD
Role: PRINCIPAL_INVESTIGATOR
Rancho Los Amigos National Rehabilitation Center
Locations
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Rancho Los Amigos National Rehabilitation Center (RLANRC)
Downey, California, United States
University of Southern California
Los Angeles, California, United States
Countries
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References
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Pyatak EA, Blanche EI, Garber SL, Diaz J, Blanchard J, Florindez L, Clark FA. Conducting intervention research among underserved populations: lessons learned and recommendations for researchers. Arch Phys Med Rehabil. 2013 Jun;94(6):1190-8. doi: 10.1016/j.apmr.2012.12.009. Epub 2012 Dec 21.
Blanche EI, Fogelberg D, Diaz J, Carlson M, Clark F. Manualization of occupational therapy interventions: illustrations from the pressure ulcer prevention research program. Am J Occup Ther. 2011 Nov-Dec;65(6):711-9. doi: 10.5014/ajot.2011.001172.
Vaishampayan A, Clark F, Carlson M, Blanche EI. Preventing pressure ulcers in people with spinal cord injury: targeting risky life circumstances through community-based interventions. Adv Skin Wound Care. 2011 Jun;24(6):275-84; quiz 285-6. doi: 10.1097/01.ASW.0000398663.66530.46.
Fogelberg D, Atkins M, Blanche EI, Carlson M, Clark F. Decisions and Dilemmas in Everyday Life: Daily Use of Wheelchairs by Individuals with Spinal Cord Injury and the Impact on Pressure Ulcer Risk. Top Spinal Cord Inj Rehabil. 2009 Fall;15(2):16-32. doi: 10.1310/sci1502-16.
Clark F, Pyatak EA, Carlson M, Blanche EI, Vigen C, Hay J, Mallinson T, Blanchard J, Unger JB, Garber SL, Diaz J, Florindez LI, Atkins M, Rubayi S, Azen SP; PUPS Study Group. Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS). Clin Trials. 2014 Apr;11(2):218-29. doi: 10.1177/1740774514521904. Epub 2014 Feb 26.
Blanchard J, Vigen C, Mallinson T, Carlson M, Garber SL, Bates-Jensen B. Pressure Injury Data Reconciliation in a Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 Nov;104(11):1833-1839. doi: 10.1016/j.apmr.2023.04.009. Epub 2023 Apr 28.
Carlson M, Vigen CLP, Rubayi S, Blanche EI, Blanchard J, Atkins M, Bates-Jensen B, Garber SL, Pyatak EA, Diaz J, Florindez LI, Hay JW, Mallinson T, Unger JB, Azen SP, Scott M, Cogan A, Clark F. Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study. J Spinal Cord Med. 2019 Jan;42(1):2-19. doi: 10.1080/10790268.2017.1313931. Epub 2017 Apr 17.
Other Identifiers
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HS-06-00064
Identifier Type: -
Identifier Source: org_study_id