Spinal Cord Injuries
Conditions
Keywords
pressure ulcer, lifestyle redesign, spinal cord injury
Brief 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.
Detailed 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.
Interventions
BEHAVIORALLifestyle 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
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious pressure ulcers | Throughout 12-month study intervention | New stage 3 or 4 pressure ulcers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ulcer related surgeries | Throughout 12-month study intervention and 12-months post intervention period | Surgical wound repair (flap, skin graft, girdlestone, other) |
| Quality of life | Throughout 12-month study intervention and 12-months post intervention period | Measured by the Medical Outcomes Study Short Form (SF-36) |
| Healthcare service utilization | Throughout 12-month study intervention and 12-months post intervention period | Estimated cost of healthcare services including inpatient, outpatient, ER, home healthcare, lab, imaging, etc. |
| Incidence of serious pressure ulcers | Throughout 12-months post intervention period | New stage 3 or 4 pressure ulcers during the second study year |
| Life Satisfaction | Throughout 12-month study intervention and 12-months post intervention period | Measured by the Satisfaction with Life Scale (SWLS) |
Countries
United States
Outcome results
None listed