Overview

This trial has been completed.

Condition spinal cord injuries
Treatment lifestyle redesign
Phase phase 3
Sponsor University of Southern California
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date September 2008
End date September 2015
Trial size 170 participants
Trial identifier NCT01999816, HS-06-00064, R01HD056267

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Occupational therapist led lifestyle redesign program to prevent pressure ulcers
lifestyle redesign Occupational therapy
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
(No Intervention)
Usual care

Primary Outcomes

Measure
Incidence of serious pressure ulcers
time frame: Throughout 12-month study intervention

Secondary Outcomes

Measure
Incidence of ulcer related surgeries
time frame: Throughout 12-month study intervention and 12-months post intervention period
Quality of life
time frame: Throughout 12-month study intervention and 12-months post intervention period
Healthcare service utilization
time frame: Throughout 12-month study intervention and 12-months post intervention period
Incidence of serious pressure ulcers
time frame: Throughout 12-months post intervention period
Life Satisfaction
time frame: Throughout 12-month study intervention and 12-months post intervention period

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury
Principal investigator Florence Clark, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Southern California.