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

NCT ID: NCT07042880

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-23

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Hospitalized Patients

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Hospitalized for more than 24 hours at a cardiology department

Exclusion Criteria

* Inability to provide informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Copenhagen

OTHER

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maria Kjøller Pedersen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Copenhagen University Hospital, North Zealand

Hillerød, , Denmark

Site Status RECRUITING

Infektionsmedicinsk Afdeling

Hvidovre, , Denmark

Site Status COMPLETED

Countries

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Denmark

Central Contacts

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Maria Kjøller Pedersen, Ph.d.

Role: CONTACT

+4521468369

Facility Contacts

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Maria Kjøller Pedersen, Ph.d.

Role: primary

+4521468369

Other Identifiers

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NNF24OC0095120

Identifier Type: -

Identifier Source: org_study_id

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