NCS: The Nordic Consensus Study

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04763863
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Anticipated Duration (Months): 11.3
• Patients Per Site Per Month: 14.1

Study Details

Study Description

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	Phase
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

• Study Type: Observational
• Anticipated Enrollment: 160 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Nordic Consensus Study
• Actual Study Start Date: Oct 20, 2020
• Anticipated Primary Completion Date: Apr 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Body Assessment [1 months]

   Evaluate Body Assessment Tool based on the Nurse Evaluation Form

Secondary Outcome Measures

1. QoL [1 months]

   Rating of the user's leakage associated QoL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Coloplast Denmark A/s	Humlebæk		Denmark	3050

Sponsors and Collaborators

• Coloplast A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT04763863
• Other Study ID Numbers: CP339
• First Posted: Feb 21, 2021
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 21, 2021