The Nordic Consensus Study (NCS)

Coloplast

Status: Completed

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

Treatments: Other: Body Assessment Tool; Other: Clinical usability evaluation of the Body Assessment Tool

Study type: Observational

Funder types: Industry

Identifiers

NCT04763863

CP339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

121 participants in 2 patient groups

Ostomates

Description:

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

Treatment:

Other: Body Assessment Tool

Stoma care nurses

Description:

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.

Treatment:

Other: Clinical usability evaluation of the Body Assessment Tool