NCT01154725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

June 30, 2010

Last Update Submit

December 11, 2012

Conditions

Colostomy

Keywords

Patient educationHealth-Related Quality of Lifepatients with stomasstomatherapyhealth economics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Economic effect

    6 months after discharge

  • Ostomy Adjustment Scale and SF-36 measurement of quality of life

    3 months (+/-2 weeks) postoperatively

  • Ostomy Adjustment Scale and SF-36 measurement of quality of life

    3-7 days postoperatively before discharge

  • SF-36 measurement of quality of life

    6 months (+/- 2 weeks) postoperatively

Study Arms (2)

Habitual stoma care

OTHER

habitual patient education

Behavioral: habitual patient education

Patient education and rehabilitation

EXPERIMENTAL

patient education and rehabilitation

Behavioral: Patient education and rehabilitation

Interventions

Patient education and rehabilitationBEHAVIORAL

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.

Also known as: health related quality of life, patient education, stoma care, stomatherapy, telephone guidance, group based learning
Patient education and rehabilitation
habitual patient educationBEHAVIORAL

habitual patient education

Habitual stoma care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery, Herlev University Hospital

Herlev, 2730, Denmark

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Related Publications (2)

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

    PMID: 24814582DERIVED

  • 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.

    PMID: 24609004DERIVED

MeSH Terms

Interventions

Patient Education as TopicRehabilitationQuality of Life

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesAftercareContinuity of Patient CarePatient CareTherapeuticsHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Anne K Danielsen, Nurse, MaClN

    Herlev University Hospital, Department of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d.student, RN

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

August 1, 2010

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

DK(2)