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长期身体残疾的老龄化

2026年11月2日 更新者:Washington University School of Medicine

通过以证据为基础的策略建设能力,改善长期残疾老年人的社区参与

The purpose of this study is to determine the feasibility and efficacy of an adapted evidence-based program (REBIL) to reduce barriers to community participation and remove fall hazards at home for adults aging with physical disabilities.

研究概览

详细说明

Investigators will test the working hypothesis that the adapted program, focused on resolving environmental barriers, removing fall hazards, and building self-management skills in the home and community, will be feasible and superior to usual care for daily activity performance and participation outcomes in adults aging with physical disabilities.

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

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

    • Missouri
      • St Louis、Missouri、美国、63108
        • Washington University School of Medicine

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

45年 至 65年 (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:

  • Age 45-65 years
  • Self-report of difficulty with at least 2 daily activities using the Older Adult Retirement Survey Activities of Daily Living (OARS ADL) scale
  • onset of a physical disability 5 years prior to participation (e.g., spinal cord injury (SCI), cerebral palsy, post-polio syndrome, stroke, amputation).
  • live within 60 miles of the research lab

Exclusion Criteria:

  • Currently institutionalized.

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:治疗
  • 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
实验性的:REBIL- Intervention arm

Participants in this arm will receive the Removing Environmental Barriers to Independent Living (REBIL) intervention.

REBIL is a complex intervention with two essential components: (1) removing environmental barriers and home hazards in the home tailored to the participant's unique abilities and limitations and (2) strategy training with the participant to help participant to be able to identify barriers in the home and community and identify potential resources and strategies to remove the barriers. Treatment includes one assessment session and four 75-minute visits in the home with an occupational therapist over 8 weeks, followed by a 6 -month assessment session by a blinded rater.

其他:Waitlist Attentional control

Participants in this arm will receive life interview visits provided by a trained occupational therapist (OT) or OT student remotely for an equivalent amount of time to the treatment group. The waitlist control group will be offered the REBIL intervention after the 6-month follow-up is completed.

The waitlist attentional control group will receive an initial assessment session then four 75 minute interview visits from an occupational therapy graduate assistant, followed by a 6-month assessment session by a blinded rater. After the 6-month follow-up is completed this group will receive the REBIL intervention.

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
In-Home Occupational Performance Evaluation (I-HOPE) Activity Score
大体时间:Baseline and 6-month follow up

The In-Home Occupational Performance Evaluation (I-HOPE) activity score measures current activity patterns of participants across 44 activities. The score ranges from 0 to 1.0, with a higher score indicating fewer problematic activities for the participant.

Baseline and 6-month follow up
In-Home Occupational Performance Evaluation (I-HOPE) Performance Score
大体时间:Baseline and 6-month follow up

The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating across up to 10 participant-prioritized activities on a scale of 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty).

Baseline and 6-month follow up
In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score
大体时间:Baseline and 6-month follow up

The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating across up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with the performance of the activity) to 5 (very satisfied with their performance of the activity).

Baseline and 6-month follow up
In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score
大体时间:Baseline and 6-month follow up

The In-Home Occupational Performance Evaluation (I-HOPE) barrier severity score is a total sum of barrier ratings (0=independent with/without a device, 1=stand-by assistance needed, 2=minimum assistance needed, 3=moderate assistance needed, 4=maximum assistance needed, 5=no activity) for all identified barriers across up to 10 prioritized activities. Multiple barriers could be identified for each prioritized activity. Higher scores indicate greater barrier severity. There is no maximum score.

Baseline and 6-month follow up
Reintegration to Normal Living Index (RNLI)
大体时间:Baseline and 6-month follow-up

The Reintegration to Normal Living Index is a disability-related quality-of life-instrument that will be used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point visual analog scale with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living.

Baseline and 6-month follow-up
Westmead Home Safety Assessment (WeHSA) Short Form
大体时间:Baseline and 6-month follow up

The Westmead Home Safety Assessment (WeHSA) short form is a performance-based assessment of fall hazards in different spaces of the home (e.g., kitchen, bathroom, hallway, bedroom etc.). WeSHA scores indicate the total number of environmental fall hazards in the home.

Baseline and 6-month follow up

次要结果测量

结果测量
措施说明
大体时间
Fall Prevention Strategy Survey (FPSS)
大体时间:Baseline and 6-month follow-up

The Fall Prevention Strategy Survey is a self-report instrument addressing protective behaviors related to fall risk among adults. It is an 11-item survey, scores range from 0 to 22 with higher scores indicating use of more fall prevention strategies.

Baseline and 6-month follow-up
Participation Scale
大体时间:Baseline and 6-month follow-up

This scale comprises 25 diverse activities across four participation domains: routines, recreation, responsibilities, and relationships. Ratings were on a five-point Likert-type scale regarding the frequency of participation, the importance of the activity, and their self-efficacy in completing it. We calculated the ratio of number of important/very important activities they could perform very much/as much as they wanted (numerator) to the number of important/very important activities (denominator).

Baseline and 6-month follow-up
Fall Rate
大体时间:6 months

Participants reported monthly on the number of falls they experienced in the past month. A fall was defined as an unexpected event in which a person comes to rest on the ground, floor, or a lower level. Fall rates were calculated as the number of falls per 1000 observed participant days.

6 months

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:Susan Stark, PhD、Washington University School of Medicine

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。

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 (实际的)

2020年11月4日

初级完成 (实际的)

2023年6月21日

研究完成 (实际的)

2023年6月21日

研究注册日期

首次提交

2020年9月8日

首先提交符合 QC 标准的

2020年10月9日

首次发布 (实际的)

2020年10月19日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 201710186

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

The data (feasibility, primary and secondary outcomes) will be shared via a data repository.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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