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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD056267 | 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 purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the intervention's cost-effectiveness and potential cost savings and its effects on participants' quality of life.
Medically serious pressure ulcers are a common complication of spinal cord injury (SCI), and are associated with high treatment costs and reduced quality of life. This study will examine the efficacy and cost-effectiveness of a promising lifestyle-based intervention designed to reduce the incidence of pressure ulcers among culturally diverse, community dwelling adults with SCI who have had serious pressure ulcers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Redesign | Experimental | Occupational therapist led lifestyle redesign program to prevent pressure ulcers |
|
| Control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Redesign | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious pressure ulcers | New stage 3 or 4 pressure ulcers | Throughout 12-month study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ulcer related surgeries | Surgical wound repair (flap, skin graft, girdlestone, other) | Throughout 12-month study intervention and 12-months post intervention period |
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Clark, PhD | University of Southern California | Principal Investigator |
| Salah Rubayi, MD | Rancho Los Amigos National Rehabilitation Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos National Rehabilitation Center (RLANRC) | Downey | California | 90242 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23262157 | Background | 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. | |
| 22214116 | Background | 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. |
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We will submit de-identified data to ICPSR
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
Measured by the Medical Outcomes Study Short Form (SF-36)
| Throughout 12-month study intervention and 12-months post intervention period |
| Healthcare service utilization | Estimated cost of healthcare services including inpatient, outpatient, ER, home healthcare, lab, imaging, etc. | Throughout 12-month study intervention and 12-months post intervention period |
| Incidence of serious pressure ulcers | New stage 3 or 4 pressure ulcers during the second study year | Throughout 12-months post intervention period |
| Life Satisfaction | Measured by the Satisfaction with Life Scale (SWLS) | Throughout 12-month study intervention and 12-months post intervention period |
| University of Southern California |
| Los Angeles |
| California |
| 90033 |
| United States |
| 21586911 | Background | 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. |
| 21603085 | Background | 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. |
| 24577972 | Background | 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. |
| 37121533 | Derived | 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. |
| 28414254 | Derived | 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. |
| D014947 | Wounds and Injuries |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013812 |
| Therapeutics |