Interdisciplinary Pressure Management & Mobility Program as an Alternative to Bed Rest: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Wound healing: We will measure changes in wound size and appearance using acetate tracings with Visatrak system, digital photography, and the Photographic wound assessment tool (PWAT).
研究概览
简要总结
People with spinal cord injuries posses many factors that increase their risk of developing pressure ulcers. Not surprisingly, approximately 82% of persons with spinal cord injury (SCI) will experience a pressure ulcer at sometime during their life. Earlier guidelines for the assessment and treatment of pressure ulcers produced by RNAO in 20027 recommended that "a client who has a pressure ulcer on a seating surface should avoid sitting." Unfortunately, this recommendation has fueled the long standing view that people with pressure ulcers should stop using their wheelchairs and return to bed. The strength of evidence assigned for this recommendation was Level=C reflecting the paucity of research evidence to support this common practice. Not only do the benefits of bed rest on healing remain to be demonstrated, there is mounting evidence that bed rest can be harmful to a person's overall health and well being. Bed rest has been shown to be strongly associated with complications in most body systems including respiratory, cardiovascular, musculoskeletal, cerebrovascular, gastrointestinal, and genital-urinary. Psychosocial complications and cognitive impacts are also well documented. Without evidence to dispel the myth that "bed rest is best" it will be difficult to change practice and avoid many of the secondary complications. This study is a pilot study to 1) determine whether pressure ulcers heal faster in individuals with SCI who receive an individualized community-based, pressure management and mobility program compared to a similar group assigned to usual care (bed rest), 2) determine the strength of the association between the intervention (pressure/mobility or bedrest) and wound healing, motor performance/independence and quality of life while adjusting for motivation to regain independence, degree of caregiver burden, and compliance with the intervention, 3) determine whether individuals with SCI who participate in a pressure/mobility management program experience fewer secondary complications than those who do not participate, 4) determine the cost-effectiveness of providing a time-efficient, pressure management and mobility program compared to bed rest.
详细描述
Hypothesis: Individuals with SCI who have pressure ulcers who receive an individualized, community-based, pressure management and mobility program will have better outcomes compared to a similar group of individuals who remain on bed rest (usual care).
Specific Objectives
- To determine whether pressure ulcers heal faster in individuals with SCI who receive an individualized community-based, pressure management and mobility program compared to a similar group assigned to usual care (bed rest).
- To determine the strength of the association between the intervention (pressure/mobility or bedrest) and wound healing, motor performance/independence and quality of life while adjusting for motivation to regain independence, degree of caregiver burden, and compliance with the intervention.
- To determine whether individuals with SCI who participate in a pressure/mobility management program experience fewer secondary complications than those who do not participate
- To determine the cost-effectiveness of providing a time-efficient, pressure management and mobility program compared to bed rest.
- To formally evaluate our ability to successfully recruit eligible patients into the full study.
- To determine the barriers and facilitators to successful implementation of a pressure management and mobility program from the perspective of the client, caregiver, and health care provider.
- To use our experiences individualizing pressure management and mobility programs to develop a preceptorship/mentorship training program for community-based pressure/mobility management that can be transferred to other regions in Ontario through distance education.
Study Design: This pilot study is a double-blind, parallel group, randomized controlled cross-over design that will be conducted in two centres over a 1.5 year period. Rigorous pilot data will ensure that our intervention has sufficient potential to warrant further investigation, will determine whether our protocol is feasible. As such, the methods and data collection strategies laid out in this protocol are meant to mimic the full trial.
Sample population We will enroll twenty individuals with SCI living in each of the two sites (Toronto (n=10) and London (n=10)) who have a Stage II to IV pressure ulcer(s) and meet the eligibility criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-80 yrs) with a spinal cord injury (SCI) resulting in quadriplegia or paraplegia
- •Stage II-IV pressure ulcer located anywhere on the body that is likely to heal over the 6 month study period.
- •Requires a wheelchair for locomotion
- •Able to travel to local wound centre to undergo detailed wound and medical assessment that includes blood analysis and wound culture.
- •Provides consent to access relevant medical records.
- •Able to adhere with study protocol, pressure management and mobility program, wound care protocol, and evaluation procedures for 8 month study period.
排除标准
- •Unable to achieve adequate pressure relief using available resources provided by research study.
- •Stage IV deep pressure sore +/- osteomyelitis that requires surgical closure.
- •Medically unstable or has or any other medical condition that would prevent the individual from sitting in wheelchair for at least 2 hours (e.g. Orthostatic hypotension).
- •Has a limited life expectancy that is not sufficient to complete the study.
研究组 & 干预措施
2
Individualized, Community-based, Pressure management and Mobility program:
干预措施: Pressure management and Mobility program (Other)
1
Usual Care
干预措施: Usual care (Other)
结局指标
主要结局
Wound healing: We will measure changes in wound size and appearance using acetate tracings with Visatrak system, digital photography, and the Photographic wound assessment tool (PWAT).
时间窗: monthly to 8 months post intervention
次要结局
- Caregiver Burden(monthly to 8 months post intervention)
- Cost Effectiveness(monthly to 8 months post intervention)
- Compliance (diary)(monthly to 8 months post intervention)
- Quality of Life (SF-12 and Cardiff Wound Impact Questionnaire)(monthly to 8 months post intervention)
- Motor Performance (Canadian Occupational Performance Measure (COPM)),(monthly to 8 months post intervention)
- Secondary complications(monthly to 8 months post intervention)
研究者
Dianne Bryant
Associate Professor
University of Western Ontario, Canada