The Effect of Patient Education and Rehabilitation on Quality of Life in Patients With Permanent Stomas

Not Applicable

Completed

• Conditions: Colostomy
• Interventions: Behavioral: habitual patient education; Behavioral: Patient education and rehabilitation

• Registration Number: NCT01154725
• Lead Sponsor: Herlev Hospital

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.

Study Timeline

• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Study Start: 2010-08
• Primary Completion: 2011-11
• Study Completion: 2012-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Habitual stoma care	habitual patient education	habitual patient education
Patient education and rehabilitation	Patient education and rehabilitation	patient education and rehabilitation

Primary Outcome Measures

Name	Time	Method
Ostomy Adjustment Scale measurement of quality of life	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 Outcome Measures

Name	Time	Method
Economic effect	6 months after discharge	The investigators will monitor readmittance and contacts and diagnostic procedures and therapeutic interventions related to stoma creation during the period from admittance to hospital until 6 months after discharge.
Ostomy Adjustment Scale and SF-36 measurement of quality of life	3-7 days postoperatively before discharge	the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
SF-36 measurement of quality of life	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.

Trial Locations

Locations (2)

Department of Surgery, Herlev University Hospital; 🇩🇰 Herlev, Denmark

Herlev University Hospital; 🇩🇰 Herlev, Denmark