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

NCT ID: NCT01154725

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Colostomy

Keywords

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Patient education Health-Related Quality of Life patients with stomas stomatherapy health economics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Habitual stoma care

habitual patient education

Group Type OTHER

habitual patient education

Intervention Type BEHAVIORAL

habitual patient education

Patient education and rehabilitation

patient education and rehabilitation

Group Type EXPERIMENTAL

Patient education and rehabilitation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

habitual patient education

habitual patient education

Intervention Type BEHAVIORAL

Other Intervention Names

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health related quality of life patient education stoma care stomatherapy telephone guidance group based learning

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Kjærgaard Danielsen

Ph.d.student, RN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne K Danielsen, Nurse, MaClN

Role: PRINCIPAL_INVESTIGATOR

Herlev University Hospital, Department of Gastroenterology

Locations

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Department of Surgery, Herlev University Hospital

Herlev, , Denmark

Site Status

Herlev University Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

References

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Danielsen AK, Rosenberg J. Patient education after stoma creation may reduce health-care costs. Dan Med J. 2014 Apr;61(4):A4659.

Reference Type DERIVED
PMID: 24814582 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24609004 (View on PubMed)

Other Identifiers

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AKD01

Identifier Type: -

Identifier Source: org_study_id