此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Stroke - 65 Plus. Continued Active Life. (Stroke65+)

2021年8月24日 更新者:Hanne Pallesen、Central Jutland Regional Hospital

Stroke - 65 Plus. Continued Active Life. A Randomised Controlled Trial of the Effect of a Novel Self-management Intervention Supporting Older Adults After Stroke

Since august 2016, the researchers at a highly specialized neurorehabilitation hospital in a Danish region with 1.2 inhabitants have in cooperation with health professionals from a specialized neurorehabilitation in a Danish municipality with 336,000 inhabitants, worked through and is still working with an iterative process in the development of a novel self-management support intervention for elderly stroke individuals.The intervention is going to be implemented into the second phase- a randomized clinical controlled trial (RCT) in the project named 'Stroke - 65 plus. Continued active life'.

研究概览

地位

完全的

干预/治疗

详细说明

Background: Elderly adults represent the majority of stroke cases worldwide. Sequelae after a stroke causes the stroke individuals to live a more isolated life 5 years after the stroke. This makes the stroke individuals an especially vulnerable group of elderly people regarding social reintegration. Reintegration into the community post-stroke depends highly on support from the family. However, the stroke individual's closest relatives are at risk of developing anxiety and depression.

The aim of this study is to investigate the effect of a novel self-management intervention supporting older adults after stroke

Methods/Design: Randomized controlled observer-blind trial. More than sixty stroke survivors over 65 years will two weeks before leaving a rehabilitation hospital be randomized to either a group receiving conventional rehabilitation (control) or a novel self-management intervention addition to standard rehabilitation.

During a period of 6 months the patients will be offered additional 6-8 sessions of self-management intervention of 45-60 minutes duration by a physiotherapist or an occupational therapist.

Study outcome measurements: Stroke Self-efficacy questionnaire, Stroke Specific Quality of Life Scale and Impact on participation and Autonomy and activity by accelerometers will be evaluated at baseline, three and nine months post hospital treatment.

Patient, informal caregiver and therapist satisfaction will be with examined with questionnaires and interviews.

Discussion: Self-management interventions are promising tools for rehabilitation of self-efficacy, quality of life as well as participation and autonomy. The introduction of novel self management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke, quality of life and burden on relatives. Stroke 65+ trial will provide further evidence of self management strategies to clinicians, patients and health economists.

研究类型

介入性

注册 (实际的)

69

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

      • Hammel、丹麦、8450
        • Region Hospital Hammmel Neurorehabilitation
    • Jutland
      • Hammel、Jutland、丹麦、8450
        • Region Hospital Hammel Neurocentre

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:

  • stroke survivors with rehabilitation needs discharge from rehabilitation hospital to home

Exclusion Criteria:

  • do not understand danish Montreal Cognitive assessment (MOCA) below 20

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:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Mentor
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors. A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
Traditional rehabilitation.
其他名称:
  • Self-mangement
有源比较器:Traditional rehabilitation
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors. A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
Traditional rehabilitation.
其他名称:
  • Self-mangement

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
Stroke Self-efficacy questionnaire
大体时间:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Change of Self-efficacy
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

次要结果测量

结果测量
措施说明
大体时间
Impact on participation and Autonomy Questionnaire
大体时间:Measured 3 and 9 months post discharged from rehabilitation hospital
Change of Impact on participation and Autonomy
Measured 3 and 9 months post discharged from rehabilitation hospital
Stroke Specific Quality of Life Scale Questionnaire(short version)
大体时间:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Change of Specific Quality of Life
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

其他结果措施

结果测量
措施说明
大体时间
Activity (accelerometers)
大体时间:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Change of activity
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Caregiver Burden Scale
大体时间:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Change of caregivers burden
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

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:Hanne Pallesen, Post Doc、Hammel Neurorehabilitation Centre and University Research Clinic

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)

2017年6月15日

初级完成 (实际的)

2020年11月15日

研究完成 (实际的)

2021年8月24日

研究注册日期

首次提交

2017年6月6日

首先提交符合 QC 标准的

2017年6月9日

首次发布 (实际的)

2017年6月12日

研究记录更新

最后更新发布 (实际的)

2021年8月25日

上次提交的符合 QC 标准的更新

2021年8月24日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

生活质量的临床试验

Mentor的临床试验

3
订阅