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OpenTrials
Completed

NCT Number: NCT04763863

The Nordic Consensus Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coloplast Denmark A/s

Humlebæk, 3050, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body Assessment Tool

Other

Assessment tool to evaluate stoma to find proper ostomy products

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.

Primary outcomes

  1. Evaluate Body Assessment Tool Based on the Nurse Evaluation Form

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Acronym: NCS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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