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

Sponsor
Herlev Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01154725
Collaborator
(none)
50
2
2
19
25
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient education and rehabilitation
  • Behavioral: habitual patient education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Patient Education and Rehabilitational Interventions on Health Related Quality of Life of Patients With Permanent Stomas Regardless of Cause
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

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:
  • health related quality of life
  • patient education
  • stoma care
  • stomatherapy
  • telephone guidance
  • group based learning
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Ostomy Adjustment Scale and SF-36 measurement of quality of life [3 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.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Surgery, Herlev University Hospital Herlev Denmark 2730
    2 Herlev University Hospital Herlev Denmark 2730

    Sponsors and Collaborators

    • Herlev Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anne Kjærgaard Danielsen, Ph.d.student, RN, Herlev Hospital
    ClinicalTrials.gov Identifier:
    NCT01154725
    Other Study ID Numbers:
    • AKD01
    First Posted:
    Jul 1, 2010
    Last Update Posted:
    Dec 12, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by Anne Kjærgaard Danielsen, Ph.d.student, RN, Herlev Hospital

    Study Results

    No Results Posted as of Dec 12, 2012