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Trial record 4 of 981 for:    scale | Norway

A Clinical Feedback System in Ostomy Care

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ClinicalTrials.gov Identifier: NCT03841071
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Western Norway University of Applied Sciences
Norwegian Nurses Organisation
Information provided by (Responsible Party):
Helse Forde

Brief Summary:

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 the present paper, we describe a study protocol for evaluating the effect of a clinical feedback system on adaption process of a patient with an ostomy, in terms of the patients' perceived experience with the clinical feedback system.

Methods: In this non-randomised controlled study, we include patients who had recently performed colostomy, ileostomy, or urostomy surgery, and those who have had an ostomy for more than a year. The intervention includes self-reported measures for adaptation to life with an ostomy and health-related quality of life, as well as patient satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery, and annually thereafter. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings. For comparison, we use published results of a historical control group comprising ostomy patients who have received standard care and have completed the same self-reported measures as the patients using the clinical feedback system. The main outcome is the last observed Ostomy Adjustment Scale score among those who have completed at least 2 consultations using the clinical feedback system. The last observed Short Form-36 score among those who have completed at least 2 consultations is also compared with that in the historical group. A 5-item scale is used to measure patient satisfaction with the consultation.

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


Condition or disease Intervention/treatment
Ostomy Quality of Life Adaptation, Psychological Other: ROM/CFS intervention

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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?
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Group/Cohort Intervention/treatment
ROM/CFS intervention
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.
Other: ROM/CFS intervention
The intervention (ROM/CFS) includes self-reported measures for adaptation to life with an ostomy and health-related quality of life, as well as patient satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery, and annually thereafter. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings.




Primary Outcome Measures :
  1. The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery [ Time Frame: >3 months follow-up ]
    The summary score of the Ostomy Adjustment Scale (lowest possible score is 34 and the highest 204). Higher scores represent better outcomes.


Secondary Outcome Measures :
  1. Generic health-related quality of life [ Time Frame: >3 months follow-up ]
    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.


Other Outcome Measures:
  1. The patients' satisfaction with the consultation [ Time Frame: >3 months follow-up ]
    The Session rating scale, using the five item scores seperately (lowest possible score is 0 and the highest 10). Higher scores represent better outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program at a outpatient ostomy clinic.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841071


Contacts
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Contact: Kirsten L Indrebø, McS 4795966010 kirsten.lerum.indrebo@helse-forde.no
Contact: John R Andersen, PhD 4748278186 john.roger.andersen@helse-forde.no

Locations
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Norway
Førde Hospital Trust Recruiting
Førde, Norway, 6812
Contact: Kirsten L Indrebø, McS         
Sponsors and Collaborators
Helse Forde
Western Norway University of Applied Sciences
Norwegian Nurses Organisation
Investigators
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Principal Investigator: John R Andersen, PhD Førde Hospital Trust

Additional Information:
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Responsible Party: Helse Forde
ClinicalTrials.gov Identifier: NCT03841071     History of Changes
Other Study ID Numbers: 2016255
2016255 ( Other Identifier: REC West )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The dataset generated during this study will not be publicly available as the patient consent and approval from the Regional Committee for Medical and Health Research Ethics prevents sharing of individual patient level data in public repositories. However, the data will be available from the corresponding author upon reasonable request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame:

Data will be available from the corresponding author upon reasonable request after publication.

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

Access Criteria: Supporting information is freely available from The Central Contact Person: Kirsten L Indrebø. Email: kirsten.lerum.indrebo@helse-forde.no.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No