Study Results
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View full resultsBasic Information
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COMPLETED
121 participants
OBSERVATIONAL
2020-10-20
2022-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ostomates
Ostomates with leakage issues and stoma created at least 3 months ago
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.
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.
Interventions
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Body Assessment Tool
Assessment tool to evaluate stoma to find proper ostomy products
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.
Eligibility Criteria
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Inclusion Criteria
* Male or female ≥18years
* Leakage issues
Exclusion Criteria
* Is pregnant or lactating
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Locations
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Coloplast Denmark A/s
Humlebæk, , Denmark
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP339
Identifier Type: -
Identifier Source: org_study_id
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