Danish translation and validation of a 41-item patient questionnaire about fundamental nursing care
Facilitating the Assessment of Fundamental Nursing Care in Denmark: Translation, Cultural Adaptation, and Validation of a 41-Item Fundamentals of Care Questionnaire
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 205 (estimated) |
| Sex | All |
| Sponsor | Nordsjaellands Hospital Academic / other |
| Locations | 2 sites (Hillerød and 1 other locations) |
| Trial ID | NCT07042880 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hillerød and 1 other locations
- Copenhagen University Hospital, North Zealand — Hillerød, Denmark (Recruiting)
- Infektionsmedicinsk Afdeling — Hvidovre, Denmark (Completed)
Study contacts
- Study coordinator: Maria Kjøller Pedersen, Ph.d.
- Email: maria.kjoeller.pedersen@regionh.dk
- Phone: +4521468369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.