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临床试验/NCT01154725
NCT01154725已完成不适用

Effect of Patient Education and Rehabilitational Interventions on Health Related Quality of Life of Patients With Permanent Stomas Regardless of Cause

Herlev Hospital4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
4
主要终点
Ostomy Adjustment Scale measurement of quality of life

研究概览

简要总结

The purpose of the experiment is to study the effect it has on patients' quality of life if they go through a structured process marked by intensified and specialized effort by ostomy nurse. This includes close monitoring during hospitalization, telephone contact and guidance following discharge and participation in a group based patient school up to 4 months after discharge .

At the same time the study also examines what the economic effect of following the intervention will have.

详细描述

Construction of an ostomy is a radical treatment with permanent physical signs of body alteration. It leads to loss of a central and very personal bodily function (excretion of faeces through the rectum) and there is a significant change in personal hygiene.

Having a colostomy is not a uniform state but is characterized by many different factors: Several types of ostomy, several underlying causes that lead to stoma creation such as cancer, several individual psychosocial profile, which naturally affect individuals differently. Patients are forced to living with a changed body image, a change in daily routines, and for some there will also be changes in lifestyle, social standing and their sexuality will be affected. At the same time patients experience a break when they are discharged from the hospital, and they may lack the practical and emotional support.

The training and education of patients is increasingly being carried out by stoma nurses both in Denmark and internationally. The primary role is to inform and prepare patients before surgery and to keep the contact with patients after surgery to ensure the fulfillment of the patient´s independent and meaningful life after ostomy construction. It is assumed that ostomy nurse's intervention and involvement are important for the patient's quality of life, but there are no studies that uniquely identifies the type of education that has the greatest effect, which applies both to content and methods.

Quality of life measurement in health care is a merging method to ensure the patient´s perspective on health treatments.It is greatly needed to test the efficacy of nursing interventions on patients' quality of life. Pressure on health services increase which makes it imperative also to include analysis and calculation of economic effect of the intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Ostomy Adjustment Scale measurement of quality of life

时间窗: 6 months (+/- 2 weeks) postoperatively

the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.

次要结局

  • Economic effect(6 months after discharge)
  • Ostomy Adjustment Scale and SF-36 measurement of quality of life(3-7 days postoperatively before discharge)
  • SF-36 measurement of quality of life(6 months (+/- 2 weeks) postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Kjærgaard Danielsen

Ph.d.student, RN

Herlev Hospital

研究点 (4)

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