Hospitalized PatientsNCT07042880
Cultural Adaptation, and Validation of Fundamentals of Care PRO-tool
An observational study of Hospitalized Patients, run by Nordsjaellands Hospital at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospitalized Patients
- How many people
- 205 participants
- Where
- 2 sitesDenmark
- Study dates
- 23 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized at cardiology department.
Who may be able to join
- Hospitalized for more than 24 hours at a cardiology department
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 1 recruiting
- Recruiting
Copenhagen University Hospital, North Zealand
Hillerød, 3400
Maria Kjøller Pedersen, Ph.d., +4521468369, maria.kjoeller.pedersen@regionh.dk
- Completed
Infektionsmedicinsk Afdeling
Hvidovre
About this study
Official title: Facilitating the Assessment of Fundamental Nursing Care in Denmark: Translation, Cultural Adaptation, and Validation of a 41-Item Fundamentals of Care Questionnaire
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.
Read the 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.
- Conditions
- Hospitalized Patients
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundamentals of Care
Measured by the Fundamentals of Care Intelligence Modelling Tool
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start23 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College Copenhagen
- Responsible party
- Principal investigator, Maria Kjøller Pedersen, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042880
- Sponsor's protocol ID
- NNF24OC0095120
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating the Assessment of Fundamental Nursing Care in Denmark: Translation, Cultural Adaptation, and Validation of a 41-Item Fundamentals of Care Questionnaire
- ClinicalTrials.gov ID
- NCT07042880
- Acronym / sponsor ID
- NNF24OC0095120
- Conditions
- Hospitalized Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- University College Copenhagen
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized at cardiology department.
Key inclusion criteria (1 listed)
- Hospitalized for more than 24 hours at a cardiology department
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Fundamentals of Care
Time frame: Baseline
Measured by the Fundamentals of Care Intelligence Modelling Tool
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalized Patients, run by Nordsjaellands Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Kjøller Pedersen, Ph.d. (+4521468369, maria.kjoeller.pedersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundamentals of Care (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.