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

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

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.

Study Overview

• Status: Completed
• Conditions: Colostomy
• Intervention / Treatment: Behavioral: habitual patient education; Behavioral: Patient education and rehabilitation

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev University Hospital
  • Herlev, Denmark, 2730
    • Department of Surgery, Herlev University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• All patients with permanent or temporary stomas regardless of cause that are expected to be able to cooperate in filling out questionnaires and who will participate in the planned interventions.

Exclusion criteria:

• Patients that post-operatively are not able to cooperate and participate in the planned interventions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Habitual stoma care; habitual patient education	Behavioral: habitual patient education; habitual patient education
Experimental: Patient education and rehabilitation; patient education and rehabilitation	Behavioral: Patient education and rehabilitation; Patients in the experimental group will receive specialized and optimized care by stoma care nurses. This includes one-on-one guiding during the hospitalization, guidance by telephone after discharge and participation in patient education 3 times after discharge.; Other Names: patient education; health related quality of life; stoma care; stomatherapy; telephone guidance; group based learning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ostomy Adjustment Scale measurement of quality of life	the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.	6 months (+/- 2 weeks) postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic effect	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.	6 months after discharge
Ostomy Adjustment Scale and SF-36 measurement of quality of life	the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.	3 months (+/-2 weeks) postoperatively
Ostomy Adjustment Scale and SF-36 measurement of quality of life	the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.	3-7 days postoperatively before discharge
SF-36 measurement of quality of life	the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.	6 months (+/- 2 weeks) postoperatively

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Anne K Danielsen, Nurse, MaClN, Herlev University Hospital, Department of Gastroenterology

Publications and helpful links

General Publications

• Danielsen AK, Rosenberg J. Patient education after stoma creation may reduce health-care costs. Dan Med J. 2014 Apr;61(4):A4659.
• Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Patient education; Health-Related Quality of Life; health economics; stomatherapy; patients with stomas
• Other Study ID Numbers: AKD01