Cultural Adaptation, and Validation of Fundamentals of Care PRO-tool

NCT07042880 | Recruiting

• 1 other identifier: NNF24OC0095120
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 2

Brief Summary

A research team from the University of Seville and Flinders University has created a new 41-item questionnaire to assess fundamental nursing care. This questionnaire focuses on three main areas: the nurse-patient relationship, addressing patients' basic care needs (physical, relational, and psychosocial), and the context of care. This tool helps nurses evaluate and track the quality of care they provide over time. 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.

Conditions

Hospitalized Patients

Outcome Measures

Primary Outcomes (1)

• Fundamentals of Care

  Measured by the Fundamentals of Care Intelligence Modelling Tool

  Baseline

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized at cardiology department.

You may qualify if:

• Hospitalized for more than 24 hours at a cardiology department

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• University College Copenhagen: collaborator

Study Sites (2)

Copenhagen University Hospital, North Zealand

Hillerød, 3400, Denmark

RECRUITING

Infektionsmedicinsk Afdeling

Hvidovre, Denmark

COMPLETED

Central Study Contacts

Maria Kjøller Pedersen, Ph.d.

CONTACT

+4521468369; maria.kjoeller.pedersen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)