Clinical trial NCT01999816: Pressure Ulcer Prevention Study in SCI
Official title: Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Injuries
Keywords: pressure ulcer
lifestyle redesign
spinal cord injury
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-12-03
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury (paraplegia or tetraplegia)
* 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:

* Present serious stage 4 pressure ulcer
* Participation in our preliminary research studies
* Participating in the neuromuscular stimulation study

Primary outcomes:
measure: Incidence of serious pressure ulcers
timeFrame: Throughout 12-month study intervention
Secondary outcomes:
measure: Incidence of ulcer related surgeries
timeFrame: Throughout 12-month study intervention and 12-months post intervention period
measure: Quality of life
timeFrame: Throughout 12-month study intervention and 12-months post intervention period
measure: Healthcare service utilization
timeFrame: Throughout 12-month study intervention and 12-months post intervention period
measure: Incidence of serious pressure ulcers
timeFrame: Throughout 12-months post intervention period
measure: Life Satisfaction
timeFrame: Throughout 12-month study intervention and 12-months post intervention period
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center (RLANRC)
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Florence Clark, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rancho Los Amigos National Rehabilitation Center
name: Salah Rubayi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.