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NCT Number: NCT07042880

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital, North Zealand, Hillerød, Denmark

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About this study

Introduction: A research team from the University of Seville and Flinders University has developed a 41-item questionnaire to assess fundamental nursing care according to the Fundamentals of Care Framework (FoC Intelligence Modelling Tool - FoC-IMT), focusing on the nurse-patient relationship, basic care needs (physical, relational, and psychosocial), and the context of care. This self-administered, patient-reported tool (PRO) helps nurses evaluate and track the patients experience of care over time.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized for more than 24 hours at a cardiology department

Exclusion criteria

  • Inability to provide informed consent

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Fundamentals of Care

    Time frame: Baseline

    Measured by the Fundamentals of Care Intelligence Modelling Tool

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Kjøller Pedersen, Ph.d.

CONTACT

[email protected]

+4521468369

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • University College Copenhagen

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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