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Completed

NCT Number: NCT01154725

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Herlev University Hospital, Herlev, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient education and rehabilitation

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.

Other names: health related quality of life, patient education, stoma care, stomatherapy, telephone guidance, group based learning

habitual patient education

Behavioral

habitual patient education

Primary outcomes

  1. 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

  1. Economic effect

    Time frame: 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

    Time frame: 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

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 1, 2010
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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