Pressure Ulcer Prevention Study in SCI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Lifestyle Redesign


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Redesign<br>Occupational therapist led lifestyle redesign program to prevent pressure ulcers | Behavioral: Lifestyle Redesign<br>* 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<br>* Other names: Occupational therapy;|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious pressure ulcers | New stage 3 or 4 pressure ulcers | Throughout 12-month study intervention | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure ulcer, lifestyle redesign, spinal cord injury