Clinical trial Recruiting at 1 site Observational

Danish translation and validation of a 41-item patient questionnaire about fundamental nursing care

Official title: Facilitating the Assessment of Fundamental Nursing Care in Denmark: Translation, Cultural Adaptation, and Validation of a 41-Item Fundamentals of Care Questionnaire

Run by Nordsjaellands Hospital · NCT07042880 · Data updated 2026-11-12

This project will translate and adapt a 41-question, patient-completed survey about basic nursing care to see if it works well for Danish hospitalized cardiology patients.

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Quick facts

Study typeObservational
SexAll
Enrollment205 (estimated)
SponsorNordsjaellands Hospital
Academic / other
Locations2 sites (Hillerød and 1 other locations)
StatusRecruiting
StartedJune 23, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 2, 2025
Trial IDNCT07042880 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Hospitalized cardiology patients who have been in hospital for more than 24 hours and are able to provide informed consent are the intended participants.

Probably not a fit

Patients who cannot provide informed consent or who are too unwell or cognitively unable to complete a self-reported questionnaire are unlikely to benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project will translate, culturally adapt, and validate the 41-item Fundamentals of Care patient-reported questionnaire for use in Danish hospitals following an eight-phase guideline (forward translation, synthesis, back translation, harmonization, pre-testing, field testing, psychometric validation, and analysis of psychometric properties). The questionnaire measures the nurse–patient relationship, patients' basic care needs (physical, relational, psychosocial), and the context of care and is self-administered by patients. Pre-testing was done with 30 hospital patients and 8 nurses in an infection medicine ward, and field testing will recruit about 205 hospitalized patients for psychometric validation. The validation will analyze reliability, factor structure, and other measurement properties to determine whether the tool performs as intended in the Danish healthcare setting.

Why it matters

Potential benefit: If successful, Danish hospitals will have a validated patient-reported tool to track and highlight where fundamental nursing care is working well or needs improvement.

How similar studies have gone: The 41-item tool has already been translated and adapted for English and used in Australia, so the approach has previous international adaptation precedent, but the Danish validation is new.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Hospitalized for more than 24 hours at a cardiology department

Exclusion Criteria:

* Inability to provide informed consent

Where it's running

  • Copenhagen University Hospital, North Zealand
    Hillerød, Denmark
    Recruiting
  • Infektionsmedicinsk Afdeling
    Hvidovre, Denmark
    Completed

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.