The Nordic Consensus Study

NCT04763863 | Completed Results

• 1 other identifier: CP339
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Stoma Site Leakage; Quality of Life; Nurse's Role; Stoma Ileostomy; Colostomy Stoma

Outcome Measures

Primary Outcomes (1)

• Evaluate Body Assessment Tool Based on the Nurse Evaluation Form

  Clinical usability evaluation of the Body Assessment Tool was based on a 6-point scale (1 being lowest satisfaction - 6 being highest satisfaction) in response to the three questions: "Does the tool offer value in clinical practice?", "Does it provide a good starting point when choosing ostomy product(s)?", and "Does it help raise the quality of care?".

  Visit 2: Week 4

Secondary Outcomes (1)

• QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control)

  Visit 1 (Week 0) and Visit 2 (Week 4)

Study Arms (2)

Ostomates

Ostomates with leakage issues and stoma created at least 3 months ago

Other: Body Assessment Tool

Stoma care nurses

Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate. Invitations were sent to stoma care nurses randomly selected from among those working in relatively large stoma care clinics.

Other: Clinical usability evaluation of the Body Assessment Tool

Interventions

Body Assessment Tool OTHER

Assessment tool to evaluate stoma to find proper ostomy products

Ostomates

Clinical usability evaluation of the Body Assessment Tool OTHER

The stoma care nurses evaluated the clinical usability of the Body Assessment Tool, which included answering the following questions: Does the tool offer value in clinical practice? Does it provide a good starting point when choosing ostomy product(s)? Does it help raise the quality of care? Participants provided their responses on a 6 point-scale (1-6), where 1 indicated the lowest satisfaction and 6 the greatest satisfaction with the tool.

Stoma care nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ostomates with leakage problems in need for stoma care

You may qualify if:

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

You may not qualify if:

• Requires a caretaker or is unable to participate in the study
• Is pregnant or lactating

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast Denmark A/s

Humlebæk, 3050, Denmark

Location

Results Point of Contact

• Title: Catarina Sternhufvud
• Organization: Coloplast AB

secast@coloplast.com

+46 (0)705 56 10 97

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: October 20, 2020
• Primary Completion: July 28, 2022
• Study Completion: September 30, 2022
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)