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The Nordic Consensus Study (NCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04763863
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Description
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Brief Summary:
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.

Condition or disease Intervention/treatment
Stoma Site Leakage Quality of Life Nurse's Role Stoma Ileostomy Colostomy Stoma Other: Body Assessment Tool

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Groups and Cohorts
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Group/Cohort Intervention/treatment
Ostomates
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


Outcome Measures
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Primary Outcome Measures :
  1. Body Assessment [ Time Frame: 1 months ]
    Evaluate Body Assessment Tool based on the Nurse Evaluation Form


Secondary Outcome Measures :
  1. QoL [ Time Frame: 1 months ]
    Rating of the user's leakage associated QoL


Eligibility Criteria
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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
Ostomates with leakage problems in need for stoma care
Criteria

Inclusion Criteria:

  • Ostomates
  • Male or female ≥18years
  • Leakage issues

Exclusion Criteria:

  • Requires a caretaker or is unable to participate in the study
  • Is pregnant or lactating
Contacts and Locations
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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): NCT04763863


Contacts
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Contact: Birte Petersen, MD +4552167100 birte@meddevhealt.com
Contact: Catarina Sternhufvud, MSC +46705561097 secast@coloplast.com

Locations
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Denmark
Coloplast Denmark A/s Recruiting
Humlebæk, Denmark, 3050
Contact: Philip Munch    +4549111242    dkphmu@coloplast.com   
Sponsors and Collaborators
Coloplast A/S
More Information
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT04763863    
Other Study ID Numbers: CP339
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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