The Nordic Consensus Study

• Conditions: Stoma Site Leakage; Quality of Life; Nurse's Role; Colostomy Stoma; Stoma Ileostomy
• Interventions: Other: Body Assessment Tool; Other: Clinical usability evaluation of the Body Assessment Tool

• Registration Number: NCT04763863
• Lead Sponsor: Coloplast A/S

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.

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 Timeline

• Study Start: 2020-10-20
• Status Verified: 2021-02
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Primary Completion: 2021-04-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ostomates	Body Assessment Tool	Ostomates with leakage issues and stoma created at least 3 months ago
Stoma care nurses	Clinical usability evaluation of the Body Assessment Tool	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.

Primary Outcome Measures

Name	Time	Method
Evaluate Body Assessment Tool Based on the Nurse Evaluation Form	Visit 2: Week 4	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?".

Secondary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (1)

Coloplast Denmark A/s; 🇩🇰 Humlebæk, Denmark