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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
170
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
Rancho Los Amigos National Rehabilitation Center (RLANRC)
Downey, California, United States
University of Southern California
Los Angeles, California, United States
Incidence of serious pressure ulcers
New stage 3 or 4 pressure ulcers
Time frame: Throughout 12-month study intervention
Incidence of ulcer related surgeries
Surgical wound repair (flap, skin graft, girdlestone, other)
Time frame: Throughout 12-month study intervention and 12-months post intervention period
Quality of life
Measured by the Medical Outcomes Study Short Form (SF-36)
Time frame: 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.
Time frame: 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
Time frame: Throughout 12-months post intervention period
Life Satisfaction
Measured by the Satisfaction with Life Scale (SWLS)
Time frame: Throughout 12-month study intervention and 12-months post intervention period
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