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Pressure Ulcer Prevention Study in SCI (PUPS)

2016年10月26日 更新者:Florence Clark、University of Southern California

Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury

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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

170

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Downey、California、美国、90242
        • Rancho Los Amigos National Rehabilitation Center (RLANRC)
      • Los Angeles、California、美国、90033
        • University of Southern California

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:控制
日常护理
实验性的:Lifestyle Redesign
Occupational therapist led lifestyle redesign program to prevent pressure ulcers
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
其他名称:
  • 职业治疗

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of serious pressure ulcers
大体时间:Throughout 12-month study intervention
New stage 3 or 4 pressure ulcers
Throughout 12-month study intervention

次要结果测量

结果测量
措施说明
大体时间
Incidence of ulcer related surgeries
大体时间:Throughout 12-month study intervention and 12-months post intervention period
Surgical wound repair (flap, skin graft, girdlestone, other)
Throughout 12-month study intervention and 12-months post intervention period
Quality of life
大体时间:Throughout 12-month study intervention and 12-months post intervention period
Measured by the Medical Outcomes Study Short Form (SF-36)
Throughout 12-month study intervention and 12-months post intervention period
Healthcare service utilization
大体时间: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.
Throughout 12-month study intervention and 12-months post intervention period
Incidence of serious pressure ulcers
大体时间:Throughout 12-months post intervention period
New stage 3 or 4 pressure ulcers during the second study year
Throughout 12-months post intervention period
Life Satisfaction
大体时间:Throughout 12-month study intervention and 12-months post intervention period
Measured by the Satisfaction with Life Scale (SWLS)
Throughout 12-month study intervention and 12-months post intervention period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Florence Clark, PhD、University of Southern California
  • 首席研究员:Salah Rubayi, MD、Rancho Los Amigos National Rehabilitation Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年9月1日

初级完成 (实际的)

2015年9月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2013年11月25日

首先提交符合 QC 标准的

2013年11月25日

首次发布 (估计)

2013年12月3日

研究记录更新

最后更新发布 (估计)

2016年10月27日

上次提交的符合 QC 标准的更新

2016年10月26日

最后验证

2016年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • HS-06-00064
  • R01HD056267 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

We will submit de-identified data to ICPSR

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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