Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 4
- 主要终点
- Incidence of serious pressure ulcers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Present serious stage 4 pressure ulcer
- •Participation in our preliminary research studies
- •Participating in the neuromuscular stimulation study
结局指标
主要结局
Incidence of serious pressure ulcers
时间窗: Throughout 12-month study intervention
New stage 3 or 4 pressure ulcers
次要结局
- Incidence of ulcer related surgeries(Throughout 12-month study intervention and 12-months post intervention period)
- Life Satisfaction(Throughout 12-month study intervention and 12-months post intervention period)
- Quality of life(Throughout 12-month study intervention and 12-months post intervention period)
- Healthcare service utilization(Throughout 12-month study intervention and 12-months post intervention period)
- Incidence of serious pressure ulcers(Throughout 12-months post intervention period)
研究者
Florence Clark
Associate Dean, Chair, and Professor Occupational Science and Occupational Therapy
University of Southern California