Quality of Life Clinical Trial
Official title:
Use of the Ostomy Adjustment Scale (OAS) as a Routine Outcome Measure of Adaptation to Life With an Ostomy Along With a Clinical Feedback System in the Follow-up of Ostomy Patients; Does it Promote Adaptation to the Life With an Ostomy?
NCT number | NCT03841071 |
Other study ID # | 2016255 |
Secondary ID | 2016255 |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | June 1, 2021 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Førde Hospital Trust | Førde |
Lead Sponsor | Collaborator |
---|---|
Helse Forde | Norwegian Nurses Organisation, Western Norway University of Applied Sciences |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The patients' satisfaction with the consultation | The Session rating scale, using the five item scores seperately (lowest possible score is 0 and the highest 10). Higher scores represent better outcomes. | At the 12 months follow-up after surgery. | |
Primary | The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery | The summary score of the Ostomy Adjustment Scale (lowest possible score is 34 and the highest 204). Higher scores represent better outcomes. | From the 3 months follow-up after surgery to the 12 months follow-up. | |
Secondary | Generic health-related quality of life | The two summary scores of the Short Form-36 (Physical Component Score and Mental Component Score). The lowest possible score is 0 and the highest 100. Higher scores represent better outcomes. | From the 3 months follow-up after surgery to the 12 months follow-up. |
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