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。

Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence (EPSPFI)

2017年1月25日 更新者：Norwegian University of Science and Technology

Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial

Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot be explained by co-morbidity or anatomical and psychological changes of aging alone. In the nursing home population previous studies suggest a prevalence between 10 and 69%, but is most often reported to be between 40 and 55%. FI leads to a high direct and indirect economic burden to the health-care system, and is an important cause og institutionalization of the elderly patients. In addition, FI is associated with shame, social isolation and reduced quality of life.

The importance of identifying treatable causes of FI in the frail elderly, rather than just managing passively, is strongly emphasized. It is indicated that the level of awareness among health personnel regarding appropriate assessment and treatment options is limited, and that FI is considered a normal part of aging.

This study is based on the assumption that FI among nursing home patients can be prevented, cured or ameliorated by offering nursing home staff knowledge of best practise. The primary objective of the study is to test the hypothesis that a multifaceted educational program for staff on assessment and treatment of FI, is associated with a reduction in patients' frequency of FI.

The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated cross-sectional approach.The results will be analysed according to multilevel and longitudinal modelling, and the study will use mixed effect models with the cluster treated as a random effect.

研究概览

地位

完全的

条件

干预/治疗

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

  • 挪威
      • Trondheim、挪威、7004
        • Sor Trondelag University College

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

  • 孩子
  • 成人
  • 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:

Nursing homes with similar:

  • patients characteristcs
  • care staff/patients ratio
  • general practitioner consultancy

Patients:

- All patients on long term care residency (residency >month)

Registered Nurses/authorized social educators:

- All working half time or more

Exclusion Criteria:

Nursing homes:

- With some kind of speciality (eks rehabilitation, dementia)

Patients:

- Short term care residency

Registered nurses/authorized social educator:

  • Working less than half time
  • Working only night shifts

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Multifaceted educational program

A multifaceted educational program for nursing home staff consisting of:

  1. One seven hours educational meeting (interactive workshop) conducted in the nursing home. Theoretical input and case-base discussions considering guidelines for nurse led assessment og interventions of patients fecal incontinence.The content will be made available as educational material.
  2. Recruitment of one local opinion leader per nursing home unit.
  3. Seven educational outreach meetings (1 hour 30 minutes per meeting) during the three months intervention period.
行为的：Multifaceted educational program
无干预：Control
The control arm will not receive any educational program and will continue with usual care. Data with information about ordinary care will be gathered as part of the data collection procedure in the study.

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
Change in frequency of fecal incontinence among patients
大体时间：Baseline, after 3 months and after 6 months
As measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012), section H: Continence. Because of relatively high risk of death and movement out of clusters, a repeated cross-sectional opproach to analyses will be used. Frequency of FI will thereby be analysed on a across-sectional group level.
Baseline, after 3 months and after 6 months

次要结果测量

结果测量
措施说明
大体时间
Remission of fecal incontinence among patients
大体时间：Baseline, after 3 months and after 6 months
For remission of FI a cohort approach to data analyses with only those identified with FI at baseline and still present at 3 and 6 month follow-up, will be included in the analyses
Baseline, after 3 months and after 6 months
Change in knowledge among registered nurses and authorized social educators
大体时间：Baseline, after 3 months and after 6 months
Measured my a multiple choice test
Baseline, after 3 months and after 6 months
Change in FI-related concerns among patients
大体时间：Baseline, after 3 months and after 6 months
Relevant concerns as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: Mood and behavior, psycho-social wellbeing, urinary continence, constipation, diarrhea, skin condition, participation in activities
Baseline, after 3 months and after 6 months
Correlates of FI among patients
大体时间：Baseline, after 3 months and after 6 months
Relevant correlates as measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012) are: cognitive functioning, communication and vision, functionality and mobility, medical diagnosis, mouth and nutrition status, medications, treatment, examination/procedures
Baseline, after 3 months and after 6 months
Change in behavior among health personnel
大体时间：Baseline, after 3 months and after 6 months
Measured by analyses of patient assessments and interventions as documented by health personnel in the electronic patient record and by the Fecal Incontinence in Nursing Home Patients questionnaire
Baseline, after 3 months and after 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。

赞助

Norwegian University of Science and Technology

合作者

Norwegian Nurses Organisation

调查人员

  • 首席研究员：Anne G Vinsnes, Professor、Norwegian University of Science and Technology

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

2014年4月1日

初级完成 (实际的)

2015年7月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2014年6月26日

首先提交符合 QC 标准的

2014年7月2日

首次发布 (估计)

2014年7月8日

研究记录更新

最后更新发布 (估计)

2017年1月26日

上次提交的符合 QC 标准的更新

2017年1月25日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HiST05

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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.

订阅