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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 205 (estimated) |
| Sponsor | Nordsjaellands Hospital Academic / other |
| Locations | 2 sites (Hillerød and 1 other locations) |
| Status | Recruiting |
| Started | June 23, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 2, 2025 |
| Trial ID | NCT07042880 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
- Study coordinator: Maria Kjøller Pedersen, Ph.d.
- Email: maria.kjoeller.pedersen@regionh.dk
- Phone: +4521468369
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
VR-based rehabilitation in the ICU for improved patient satisfaction and function
This trial tests immersive virtual reality rehab in ICU patients to see if it improves satisfaction and functional outcomes.
-
Dietitian-led nutrition care in hospital wards
This trial tests whether having clinical dietitians lead nutritional care for adults in medical wards improves meals, well‑being, and reduces hospital stay and costs.
-
Therapy Dog Walks to Boost Mobility in Trauma Patients
This study tests whether walking with a certified therapy dog helps adult and pediatric trauma patients move more during a hospital stay.
-
Telemanagement program for older nursing home residents after hospital discharge
This study is testing a new telemanagement program for older nursing home residents who just left the hospital to see if it improves their health and care.
-
Improving how feeding tubes are placed in children using proven best practices.
This project will try updated evidence-based methods and nurse education to improve feeding tube placement for hospitalized children.
-
Monitoring severe bacterial infections in hospitalized children
This study looks at how common and serious bacterial infections are in children in intensive care to help improve how these infections are treated and prevented.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.