Pressure Ulcer Prevention Study in SCI (PUPS)

University of Southern California

Status and phase

Completed

Phase 3

Conditions

Spinal Cord Injuries

Treatments

Behavioral: Lifestyle Redesign

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01999816

HS-06-00064

R01HD056267 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.