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Recruiting NCT07042880

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

Observational Hospitalized Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Hospitalized Patients. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Fundamentals of Care [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Hospitalized for more than 24 hours at a cardiology department

Exclusion criteria

  • Inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Denmark · 2 centers
  • Copenhagen University Hospital, North Zealand — Hillerød
  • Infektionsmedicinsk Afdeling — Hvidovre

Identifiers

NCT: NCT07042880 · NNF24OC0095120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗