The Nordic Consensus Study (NCS)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Nurse's Role; Colostomy Stoma; Stoma Ileostomy; Stoma Site Leakage
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Birte Petersen, MD; Phone Number: +4552167100; Email: birte@meddevhealt.com
• Study Contact Backup: Name: Catarina Sternhufvud, MSC; Phone Number: +46705561097; Email: secast@coloplast.com

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Recruiting
    • Coloplast Denmark A/s
    • Contact: Philip Munch; Phone Number: +4549111242; Email: dkphmu@coloplast.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ostomates with leakage problems in need for stoma care

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Assessment	Evaluate Body Assessment Tool based on the Nurse Evaluation Form	1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL	Rating of the user's leakage associated QoL	1 months

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CP339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No