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Patient Participation in Prevention of Loss of Functions

2015年7月30日 更新者:Tove Lindhardt Damsgaard、Herlev Hospital

Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients

Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive interventions on readmission rates, loss of functions, quality of life and cost-benefit.

研究概览

详细说明

At baseline:

Nutritional status, BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test), quality of life (EQ5D), coping (Sense of Coherence 13 item scale), patient experience (NORPEQ), medication management (MedMaide).

At follow-up three months after discharge:

BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test) and EQ5D. In addition, need for initiated municipal assistance after discharge. Project employee who performs data collection is blinded to the group to which the patient is randomized.

The control group Patients in the control group undergo the same measurements and registrations at discharge and 3 - month follow-up, as the intervention groups, but receive otherwise usual treatment and care, and are discharged without further intervention. After six months control patients receive a report comprising the screening results, relevant information material and a cover letter. Patients' GP and municipality care section receive a summary of outcomes, as well as a cover letter.

Register data Information on mortality, readmissions and services in primary health care are obtained after 6 months from the National Patient Register, Population Register and municipalities.

研究类型

介入性

注册 (实际的)

300

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

      • Herlev、丹麦、2730
        • Herlev Hospital

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

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 65 years or older
  • Living in their own home with no contact to the Municipality, both before and after admission
  • Discharged from Department o105 or the Acute Receiving Unit <48 hours from admission.

Exclusion Criteria:

  • Patients with life-threatening disease in the terminal stage
  • Patients who does not speak and understand Danish
  • Patients who are not able to communicate and collaborate, with regards to the measurements

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
其他:Empowerment
Patients in the intervention group 1 receive a communication report which will also be sent to the physician and home care. In communication report includes the results and interpretation and explanation of the measurements in layman's terms. The report also includes relevant and targeted information on pain management, depression among the elderly, dementia and disability in old age and ways to maintain and improve functional capacity. Links and addresses of relevant, local organizations, and networks are also included. The information material is also included in the report sent to the General Practitioner (GP) and home care.
To give patients the necessary resources to take care of their own health
其他:Conversation with Nurse
Patients in the intervention group 2 gets clarification and follow-up conversation with a nurse anchored in both medical department and municipalities. The nurse is "blinded" in relation to the patient's screening results. Problems identified in connection therewith are communicated to the GP and home care.
To find out, if the nurse, using her ....
无干预:Controle Group
Patients in the control group are undergoing the same measurements and records at discharge, as the intervention group, but are otherwise receiving treatment and care as usual without further 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
Number of participants who have been readmitted to hospital
大体时间:01.03.2013 - 12.31.2014
Number of participants who have been readmitted to hospital. Measured 6 months after admission.
01.03.2013 - 12.31.2014

次要结果测量

结果测量
措施说明
大体时间
Mortality
大体时间:01.04.2014 - 31.12.2014
Mortality. Number of participants, who have died. Measured 6 months after admission.
01.04.2014 - 31.12.2014
Functional ability
大体时间:31.12.2014

Measured 3 months after discharge.

Functional ability

Handgrip-strength 4 second test: Hand- and forearm muscular strength in kg. and 30 second chair stand test: Lower-body muscle strength

31.12.2014
Primary Healthcare Services
大体时间:01.04.2013 - 31.12.2014
Delivered services in Primary Healthcare. Measured 6 months after admission.
01.04.2013 - 31.12.2014

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:Tove L. Damsgaard、Herlev Hospital

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

2013年1月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年6月1日

研究注册日期

首次提交

2013年3月20日

首先提交符合 QC 标准的

2013年4月28日

首次发布 (估计)

2013年5月1日

研究记录更新

最后更新发布 (估计)

2015年7月31日

上次提交的符合 QC 标准的更新

2015年7月30日

最后验证

2015年7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

  • H-1-2012-118

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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