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A Clinical Feedback System in Ostomy Care

H

Helse Forde

Status

Unknown

Conditions

Quality of Life
Ostomy
Adaptation, Psychological

Treatments

Other: ROM/CFS intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03841071
2016255 (Other Identifier)

Details and patient eligibility

About

Background: Living with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up with a stoma care nurse is usually performed after surgery to support the adaptation process. In this project, we describe a new model of ostomy care, where a clinical feedback system (CFS) is implemented in order to improve the adaption process of patients with an ostomy. We also present a plan for evaluating patients experience with the CFS and their clinical outcomes.

Methods: We include patients who had recently performed colostomy, ileostomy, or urostomy surgery. The intervention includes self-reported measures for adaptation to life with an ostomy and health-related quality of life (HRQoL), as well as patient experiences and satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings. Patient experiences and satisfaction with care will be measured with the Generic Short Patient Experiences Questionnaire. Adaptation to the life with ostomy will be measured with the Ostomy Adjustment Scale, and HRQoL with the Short Form 36.

Discussion: This study presents a novel approach that could lead to improved consultation, more patient involvement, and better adaptation to life with an ostomy.

Full description

The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >18 years of age
  • Living with a colostomy, ileostomy, or urostomy for a minimum of 3 months
  • Being able to read and write Norwegian

Exclusion criteria

  • < The 3 weeks follow-up after surgery are not included
  • Patients who have their ostomy removed <12 months after surgery

Trial design

100 participants in 1 patient group

ROM/CFS intervention
Description:
The ROM/CFS group (N\>100), consists of patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program of the outpatient ostomy clinic at the Department of Surgery, Førde Central Hospital from April 2018 to June 2021.
Treatment:
Other: ROM/CFS intervention

Trial contacts and locations

1

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Central trial contact

Kirsten L Indrebø, McS; John R Andersen, PhD

Data sourced from clinicaltrials.gov

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