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Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial (ATUTI)

Experimental Control Investigation of the Impact of an Assistive Technology Updating and Tune up Intervention on the User-caregiver Dyad: a Multi-site Trial

The purpose of this study is to determine the effectiveness of an assistive technology updating and tune up intervention on users and their caregivers. This intervention includes 4 components:

  • an in-residence assessment of the mobility preferences of the older person and his/her caregiver
  • a detailed review of forms of assistance, technological and human, that are currently being used
  • recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy
  • therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver. The intervention is provided to the immediate treatment following the administration of baseline measures and the delayed intervention group six weeks later, after an additional baseline measurement. The treatment is six weeks long and the follow-up is 26 weeks.

Hypothesis 1: For community-dwelling older people, an intervention that increases the appropriateness of existing or new assistive technology(AT) for mobility or self-care will alter established patterns of human assistance, such that caregiver burden is reduced or eliminated.

Hypothesis 2: At the same time, AT users will report less difficulty in mobility or self-care, as well as enhanced subjective well-being, and satisfaction with their modified personal assistance strategy.

Hypothesis 3: Following the AT intervention, caregivers will report reduced physical and/or psychological demands and increased satisfaction with their caregiving-related activities compared with

  • the pre-intervention period
  • caregivers in a delayed intervention control group. Hypothesis 4: Decreased physical and/or psychological demands on helpers will be associated with increases in device users' satisfaction with their personal assistance strategies.

研究概览

研究类型

介入性

注册 (实际的)

88

阶段

  • 阶段2

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

    • British Columbia
      • Vancovuer、British Columbia、加拿大、V6B 5K3
        • Simon Fraser University
    • Quebec
      • Montreal、Quebec、加拿大
        • Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
      • Montreal、Quebec、加拿大
        • the Centre de santé et des services sociaux Cavendish
      • Montreal、Quebec、加拿大
        • the Centre de santé et des services sociaux de Laval

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

65年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Users: Aged 65 years and over
  • Have moderate to severe disability that limits their ability to move from place to place independently and/or to perform self-care activities.
  • Living at home
  • Receiving 2 or more hour per week of assistance with mobility and/or self-care activities from a non-professional, caregiver who is also willing to take part in the study.
  • Those caregivers will be adults aged 18 years and over.

Exclusion Criteria:

  • Assistive technology users will be excluded if they have severe aphasia, are currently on a community occupational therapist caseload, or are unable to communicate in English or French.

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Immediate intervention
Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.
This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.
实验性的:Delayed Intervention
Subjects and their caregivers who are randomized to this group will receive the intervention after baseline measurements are administered twice (6 weeks apart).
This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Assessment of Life Habits
大体时间:baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
Caregivers: Caregiver Assistive Technology Outcome Measure
大体时间:base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later

次要结果测量

结果测量
大体时间
Individually Prioritized Problem Assessment
大体时间:Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Functional Autonomy Measurement System
大体时间:Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Psychological Impact of Assistive Devices Scale
大体时间:Imediately after intervention. 16 weeks later
Imediately after intervention. 16 weeks later
Satisfaction with Personal Assistance Strategy
大体时间:Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later

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:Louise Demers, PhD、Université de Montréal

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

2009年6月1日

初级完成 (实际的)

2011年8月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2009年6月24日

首先提交符合 QC 标准的

2009年6月24日

首次发布 (估计)

2009年6月25日

研究记录更新

最后更新发布 (估计)

2014年2月19日

上次提交的符合 QC 标准的更新

2014年2月14日

最后验证

2014年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CRIUM-8317
  • NIDRR: H133A060062

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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