The Nordic Consensus Study (NCS)
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|ClinicalTrials.gov Identifier: NCT04763863|
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment|
|Stoma Site Leakage Quality of Life Nurse's Role Stoma Ileostomy Colostomy Stoma||Other: Body Assessment Tool|
The primary objective is to evaluate the usability of the Body Assessment Tool for the nurse. The secondary objectives are to explore if the use of Body Assessment Tool has an impact on the leakage associated Quality of Life and leakage incidences.
Forty to fifty ostomates will be enrolled from each Nordic country (i.e. Denmark, Sweden, Norway and Finland). The users will be recruited from 5-10 clinics in each country. The evaluation will include 1 visit at the clinic and at least 1 phone call visit to the user (end-of study phone visit).
The usability of the Body Assessment Tool will be evaluated by the nurses. The user's leakage and QoL will be evaluated by the end-users.
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||The Nordic Consensus Study|
|Actual Study Start Date :||October 20, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Ostomates with leakage issues and stoma created at least 3 months ago
Other: Body Assessment Tool
Assessment tool to evaluate stoma to find proper ostomy products
- Body Assessment [ Time Frame: 1 months ]Evaluate Body Assessment Tool based on the Nurse Evaluation Form
- QoL [ Time Frame: 1 months ]Rating of the user's leakage associated QoL
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): NCT04763863
|Contact: Birte Petersen, MDfirstname.lastname@example.org|
|Contact: Catarina Sternhufvud, MSCemail@example.com|
|Coloplast Denmark A/s||Recruiting|
|Humlebæk, Denmark, 3050|
|Contact: Philip Munch +4549111242 firstname.lastname@example.org|