Pressure Ulcer Prevention Study in SCI

Spinal Cord Injuries Clinical Trial

— PUPS  

Official title:

Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999816
• Other study ID #: HS-06-00064
• Secondary ID: R01HD056267
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2013
• Last updated: October 26, 2016
• Start date: September 2008
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitation Center (RLANRC)	Downey	California
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious pressure ulcers	New stage 3 or 4 pressure ulcers	Throughout 12-month study intervention	No
Secondary	Incidence of ulcer related surgeries	Surgical wound repair (flap, skin graft, girdlestone, other)	Throughout 12-month study intervention and 12-months post intervention period	No
Secondary	Quality of life	Measured by the Medical Outcomes Study Short Form (SF-36)	Throughout 12-month study intervention and 12-months post intervention period	No
Secondary	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	No
Secondary	Incidence of serious pressure ulcers	New stage 3 or 4 pressure ulcers during the second study year	Throughout 12-months post intervention period	No
Secondary	Life Satisfaction	Measured by the Satisfaction with Life Scale (SWLS)	Throughout 12-month study intervention and 12-months post intervention period	No

External Links

•   University of Southern California Pressure Ulcer Prevention Project