Cultural Adaptation, and Validation of Fundamentals of Care PRO-tool
NCT ID: NCT07042880
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
205 participants
OBSERVATIONAL
2025-06-23
2026-12-31
Brief Summary
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The questionnaire is a self-administered, patient-reported tool. The questionnaire has been translated into English and adapted for use in Australia, but not yet in Danish. Senior Researcher Maria Kjøller Pedersen from Copenhagen University Hospital, North Zealand is leading the effort to translate and adapt it for Denmark in collaboration with University College Copenhagen.
The goal of this study is to translate, adapt, and validate the questionnaire for use in the Danish healthcare system.
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Detailed Description
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The questionnaire has been translated into English and adapted for use in Australia. Senior Researcher Maria Kjøller Pedersen from Copenhagen University Hospital, North Zealand, is leading the effort to translate and adapt it for Denmark in collaboration with University College Copenhagen. The goal is to translate, adapt, and validate the questionnaire for the Danish healthcare system.
Methods: The study will follow Cruchinho's guideline for translation, cross-cultural adaptation, and validation, comprising eight phases: Forward Translation, Forward Translation Synthesis, Back Translation, Harmonization, Pre-testing, Field Testing, Psychometric Validation, and Psychometric Properties Analysis.
Pre-testing was conducted in a hospital setting. Hospital patients (n=30) and nurses (n=8) were included from Hvidovre Hospital's infection medicine department.
Field testing and validation will be conducted in hospital settings. Hospital patients (n=205) will be recruited from Nordsjællands Hospital's cardiology departments.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University College Copenhagen
OTHER
Nordsjaellands Hospital
OTHER
Responsible Party
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Maria Kjøller Pedersen
Principal Investigator
Locations
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Copenhagen University Hospital, North Zealand
Hillerød, , Denmark
Infektionsmedicinsk Afdeling
Hvidovre, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NNF24OC0095120
Identifier Type: -
Identifier Source: org_study_id
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