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: Completed
• Conditions: Quality of Life; Nurse's Role; Colostomy Stoma; Stoma Ileostomy; Stoma Site Leakage
• Intervention / Treatment: Other: Body Assessment Tool; Other: Clinical usability evaluation of the 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 for individuals living with ostomies.

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 (Actual): 121

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast Denmark A/s

Participation Criteria

Eligibility Criteria

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

• 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

2

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
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control)	The Ostomy Leak Impact (OLI) score comprises 22 questions, divided into the three domains: emotional impact (10 questions), usual and social activities (8 questions), and coping and in control (4 questions). The response to each question is rated on a 4-point Likert scale: 'all of the time', 'often', 'sometimes', and 'rarely or never' with higher scores indicating a better outcome. These responses are scored 0,1,2, and 3 respectively in the data processing. Because the domains contain a different number of questions, the score for each was transformed to the range of 0-100 to enable comparison across the three domains; the higher the score, the better level of leakage-related quality of life.	Visit 1 (Week 0) and Visit 2 (Week 4)

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): September 30, 2022

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 (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: August 1, 2024

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