NCT04763863

The Nordic Consensus Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 121 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Body Assessment Tool	Assessment tool to evaluate stoma to find proper ostomy products
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.

Timeline

• Start date: 2020-10-20
• Primary completion: 2022-07-28
• Completion: 2022-09-30
• First posted: 2021-02-21
• Last updated: 2024-09-05
• Results posted: 2024-09-05

Locations

1 site across 1 country: Denmark