PROMHUMANCUIDANCT06174844
Assessment of the Humanisation of Care in Hospitals in Andalusia-Spain
An observational study of PROM and Satisfaction, Patient, run by University of Seville at 1 site in Spain.
Trial summary
Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care. These data will be related to health outcomes such as pain, sleep quality, anxiety levels, adverse events (pressure injuries, falls, and mortality), satisfaction with the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- PROM, Satisfaction, Patient, Satisfaction, Personal
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients admitted to the internal medicine and emergency units of the participating hospitals during the sampling time
Who may be able to join
- All patients admitted to the internal medicine and emergency units of the participating hospitals during the sampling time.
Who cannot join
- Patients presenting with haemodynamic instability or emergencies at the time of sampling
- Patients with cognitive impairment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Virgen del Rocío
Seville, 41013
Regina Allande-Cussó, Dr., rallande@us.es
Ana-María Porcel-Gálvez, Prof., aporcel@us.es
About this study
Official title: Evaluation and Development of the HUMANisation of CARE in the Andalusian Public Health System in Complex User Units and Hospital Emergency Units: Attention to Frailty, Prevention of Adverse Events, and the Impact of the Nurse-patient Relationship on Health Outcomes
Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care. These data will be related to health outcomes such as pain, sleep quality, anxiety levels, adverse events (pressure injuries, falls, and mortality), satisfaction with the care received, and experience in communication processes with health professionals.
Data will also be collected on work ergonomics variables (stress, burnout, working conditions, ratios) of nurses and health technicians, which will also be related to the health outcomes collected.
- Conditions
- PROM, Satisfaction, Patient, Satisfaction, Personal, Stress, Burnout, Professional, Hospital Acquired Condition
- Being tested
- No intervention applied
- Keywords
- Humanization of care, Health outcomes
- Medical subject headings
- Patient Satisfaction, Personal Satisfaction, Burnout, Professional, Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention appliedOther
No intervention applied: data will only be collected in the indicated sampling periods from patients admitted to the participating hospitals.
| Study group | Role | What they receive |
|---|---|---|
| Sample 1 | Data collected from 1st January to 30th June of 2024 Receives: Other: No intervention applied | |
| Sample 2 | Data collected from 1st January to 30th June of 2025 Receives: Other: No intervention applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health outcomes
Levels obtained in the health outcomes identified as study variables: anxiety, measured with the Golberg scale; sleep quality, measured with the Athens Sleep Scale; frailty status, measured with the Tilburg Index; level of pain, measured with the Visual Analogue Pain Scale; level of care dependency, measured with the INICIARE scale; and the variables of mortality, falls, venous catheter infection and pressure injuries, which will be asked with items created ad-hoc. We will also study the association between the results obtained with the aforementioned scales and the variables of organisational context and structure of the centre: management leadership, measured with the Leadership Scale; nurse-patient relationship, measured with the NIC_CA Scale; work stress, measured with the Nursing Stress Scale; work conditions, measured with the PES-NWI Scale; and the variables of turnover intention and nurse-patient ratio, measured with questions designed ad hoc.
Measured: 12 months
Adverse events
Design of a predictive model based on regression models of the occurrence of adverse events (falls, mortality, venous catheter infection pressure injuries, which will be asked with items created ad-hoc) and their relationship with the rest of the study variables (assessed with the scales used for outcome 1).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PROMStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Andalusian Health Service
- Responsible party
- Principal investigator, REGINA ALLANDE CUSSO, University of Seville
- Investigators
- Regina Allande-Cussó, Dr., Principal investigator, Andalusian Health Service and University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174844
- Sponsor's protocol ID
- PI22/00373
- Acronym
- HUMANCUIDA
- Status last verified
- May 2024
- First submitted
- 6 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The collected data is personal and will not be shared or publicized. These data will be stored by the research team for 10 years, following the specifications of the Ethics Committee that approved the Ethical opinion.
Publications
Allande-Cusso R, Mejias-Martin YA, Quinoz-Gallardo MD, Porcel-Galvez AM. The impact of humanising hospital care on health outcomes: an observational study protocol. BMC Nurs. 2025 Apr 28;24(1):463. doi: 10.1186/s12912-025-03105-w.
PubMed 40296139
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Development of the HUMANisation of CARE in the Andalusian Public Health System in Complex User Units and Hospital Emergency Units: Attention to Frailty, Prevention of Adverse Events, and the Impact of the Nurse-patient Relationship on Health Outcomes
- ClinicalTrials.gov ID
- NCT06174844
- Acronym / sponsor ID
- HUMANCUIDA / PI22/00373
- Conditions
- PROM, Satisfaction, Patient, Satisfaction, Personal, Stress, Burnout, Professional, Hospital Acquired Condition
- Keywords
- Humanization of care, Health outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Andalusian Health Service
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Dec 2023 (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.
Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care. These data will be related to health outcomes such as pain, sleep quality, anxiety levels, adverse events (pressure injuries, falls, and mortality), satisfaction with the care received, and experience in communication processes with health professionals.
Data will also be collected on work ergonomics variables (stress, burnout, working conditions, ratios) of nurses and health technicians, which will also be related to the health outcomes collected.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sample 1 | – | Other: No intervention appliedData collected from 1st January to 30th June of 2024 |
| Sample 2 | – | Other: No intervention appliedData collected from 1st January to 30th June of 2025 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the internal medicine and emergency units of the participating hospitals during the sampling time
Key inclusion criteria (1 listed)
- All patients admitted to the internal medicine and emergency units of the participating hospitals during the sampling time.
Key exclusion criteria (2 listed)
- Patients presenting with haemodynamic instability or emergencies at the time of sampling
- Patients with cognitive impairment
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 intervention appliedNo intervention applied: data will only be collected in the indicated sampling periods from patients admitted to the participating hospitals. | Other | Sample 1, Sample 2 |
Primary outcome
Health outcomes
Time frame: 12 months
Levels obtained in the health outcomes identified as study variables: anxiety, measured with the Golberg scale; sleep quality, measured with the Athens Sleep Scale; frailty status, measured with the Tilburg Index; level of pain, measured with the Visual Analogue Pain Scale; level of care dependency, measured with the INICIARE scale; and the variables of mortality, falls, venous catheter infection and pressure injuries, which will be asked with items created ad-hoc. We will also study the association between the results obtained with the aforementioned scales and the variables of organisational context and structure of the centre: management leadership, measured with the Leadership Scale; nurse-patient relationship, measured with the NIC_CA Scale; work stress, measured with the Nursing Stress Scale; work conditions, measured with the PES-NWI Scale; and the variables of turnover intention and nurse-patient ratio, measured with questions designed ad hoc.
Adverse events
Time frame: 12 months
Design of a predictive model based on regression models of the occurrence of adverse events (falls, mortality, venous catheter infection pressure injuries, which will be asked with items created ad-hoc) and their relationship with the rest of the study variables (assessed with the scales used for outcome 1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 40296139Allande-Cusso R, Mejias-Martin YA, Quinoz-Gallardo MD, Porcel-Galvez AM. The impact of humanising hospital care on health outcomes: an observational study protocol. BMC Nurs. 2025 Apr 28;24(1):463. doi: 10.1186/s12912-025-03105-w.
- Individual participant dataSharing planned: No. The collected data is personal and will not be shared or publicized. These data will be stored by the research team for 10 years, following the specifications of the Ethics Committee that approved the Ethical opinion.
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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. This study is not recruiting at the moment.
Regina Allande-Cussó, Dr. principal investigator
Andalusian Health Service and University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PROM and Satisfaction, Patient, run by University of Seville at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regina Allande-Cussó, Dr. (+34954551475, rallande@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health outcomes (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06174844, which also lists 1 linked publication.
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 8 May 2024.