Clinical trial NCT01154725: The Effect of Patient Education and Rehabilitation on Quality of Life in Patients With Permanent Stomas
Official title: Effect of Patient Education and Rehabilitational Interventions on Health Related Quality of Life of Patients With Permanent Stomas Regardless of Cause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colostomy
Keywords: Patient education
Health-Related Quality of Life
patients with stomas
stomatherapy
health economics
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ostomy Adjustment Scale measurement of quality of life
timeFrame: 6 months (+/- 2 weeks) postoperatively
Secondary outcomes:
measure: Economic effect
timeFrame: 6 months after discharge
measure: Ostomy Adjustment Scale and SF-36 measurement of quality of life
timeFrame: 3 months (+/-2 weeks) postoperatively
measure: Ostomy Adjustment Scale and SF-36 measurement of quality of life
timeFrame: 3-7 days postoperatively before discharge
measure: SF-36 measurement of quality of life
timeFrame: 6 months (+/- 2 weeks) postoperatively
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Surgery, Herlev University Hospital
city: Herlev
country: Denmark
facility: Herlev University Hospital
Study officials:
affiliation: Herlev University Hospital, Department of Gastroenterology
name: Anne K Danielsen, Nurse, MaClN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danielsen AK, Rosenberg J. Patient education after stoma creation may reduce health-care costs. Dan Med J. 2014 Apr;61(4):A4659.
citation: 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.