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Clinical Trials/NCT01154725
NCT01154725
Completed
Not Applicable

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

Herlev Hospital2 sites in 1 country50 target enrollmentAugust 2010
ConditionsColostomy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colostomy
Sponsor
Herlev Hospital
Enrollment
50
Locations
2
Primary Endpoint
Ostomy Adjustment Scale measurement of quality of life
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
March 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne Kjærgaard Danielsen

Ph.d.student, RN

Herlev Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ostomy Adjustment Scale measurement of quality of life

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (2)

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