Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2018-04-01
2021-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Patient Education and Rehabilitation on Quality of Life in Patients With Permanent Stomas
NCT01154725
Relationship and Sexual Satisfaction of Stoma Patients
NCT05344781
Communication Intervention for Fecal Ostomy Surgery
NCT06320002
Effectiveness of Health Education as a Nursing Intervention in Improving Quality of Life and Reducing Symptoms of Anxiety and Depression in Ostomy Patients Following Digestive Surgery: A Quasi-Experimental Study.
NCT07347158
Effect of Stoma Prehabilitation on Stoma Patients
NCT04692610
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Living with a colostomy, ileostomy, or urostomy for a minimum of 3 months
* Being able to read and write Norwegian
Exclusion Criteria
* Patients who have their ostomy removed \<12 months after surgery
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Western Norway University of Applied Sciences
OTHER
Norwegian Nurses Organisation
OTHER
Helse Forde
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John R Andersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Førde Hospital Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Førde Hospital Trust
Førde, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kirsten L Indrebø, McS
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Indrebo KL, Aasprang A, Olsen TE, Andersen JR. Factors associated with leakage in patients with an ostomy: A cross-sectional study. Nurs Open. 2023 Jun;10(6):3635-3645. doi: 10.1002/nop2.1612. Epub 2023 Jan 24.
Indrebo KL, Aasprang A, Olsen TE, Andersen JR. Psychometric Properties of New Subscales of the Ostomy Adjustment Scale: A Cross-Sectional Study. Patient Relat Outcome Meas. 2021 Mar 15;12:65-75. doi: 10.2147/PROM.S300604. eCollection 2021.
Indrebo KL, Aasprang A, Olsen TE, Andersen JR. A new model of patient-reported outcome monitoring with a clinical feedback system in ostomy care: rationale, description and evaluation protocol. Health Qual Life Outcomes. 2020 Jan 15;18(1):12. doi: 10.1186/s12955-019-1261-3.
Related Links
Access external resources that provide additional context or updates about the study.
Study approval from the Regional Committees for Medical and Health Research Ethics (REC)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016255
Identifier Type: OTHER
Identifier Source: secondary_id
2016255
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.