Nurse PractitionersNUPRA-DINCT05520203
Role Development, Implementation and Evaluation of Nurse Practitioners
An observational study of Nurse Practitioners and Implementation Research, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
Hospitals face new challenges in providing sustainable high quality care as the prevalence of chronic conditions, multimorbidity and the complexity of care increases. The high burden on healthcare teams, the growing costs and the increasing scarcity in healthcare providers (HCPs) result in unmet needs of patients and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nurse Practitioners, Implementation Research, Quality of Care
- What is being tested?
- Care provided by the Nurse Practitioner
- How many people
- 1,000 participants
- Where
- 2 sitesBelgium
- Study dates
- 17 May 2021to 1 Mar 2024
- How long will I take part?
- 1 Year
- 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: Patients - Patients (or their parents in the paediatric department) HCPs * Representatives of all relevant stakeholders (from each department) will be invited to participate (eg. head(s) of the medical department(s), physicians, physicians in training, (head) nurses, care managers, the chief medical officer, specialised nurses, social worker, pharmacist). * All HCPs who are currently involved in the care process of the targeted patient population.
Who may be able to join
- Admitted on the participating ward (digestive surgery) or diagnosed stable liver cirrhosis or pediatric epilepsy
- Be conscious
- Speak Dutch
- Have at least three months of clinical experience on the ward
- Key stakeholders in the process of development, implementation and/or evaluation
Who cannot join
- Dementia or other severe cognitive/mental disorders
- Health care providers
- No contact with the nurse practitioner
- Internship
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ghent University Hospital
Ghent, East Flanders, 9000
University Hospital Ghent
Ghent, 9000
About this study
Official title: Role Development, Implementation and Evaluation of Nurse Practitioners in a Belgian University Hospital.
Hospitals face new challenges in providing sustainable high quality care as the prevalence of chronic conditions, multimorbidity and the complexity of care increases. The high burden on healthcare teams, the growing costs and the increasing scarcity in healthcare providers (HCPs) result in unmet needs of patients and their families and a high workload on HCPs. Worldwide there is growing recognition that new care models integrating nurse practitioners (NPs) in interdisciplinary teams could contribute to respond to these challenges.
ANP is defined as an "advanced practice nurse (APN) who integrates clinical skills associated with nursing and medicine in order to assess, diagnose and manage patients in primary healthcare settings and acute care populations as well as ongoing care for populations with chronic illness".
Read more
Despite the proven benefits of integrating NPs in interdisciplinary teams, the introduction of NPs in Belgium is at an early stage. Advanced practice nurses, including NPs, are formally recognized in Belgium since 2019, but there is still no legal framework in which additional rights or agreements compared to other nursing groups are defined. Given the early stage of introduction, little is known about the development, implementation and impact of NPs in the Belgian health care context. Insights in implementation processes and the effectiveness of NP roles at different levels can inform healthcare managers and policy makers for future (nation-wide) implementation in a hospital setting.
The overall objective of this longitudinal pre-post mixed methods study is to develop, implement and evaluate the integration of the role of NPs in four different departments in a Belgian university hospital.
Read the detailed description
A mixed methods design is used to enrich the gathered data, resulting in an integrated approach for addressing the complexity of this study. This method creates the opportunity to triangulate and integrate quantitative and qualitative data resulting in a complete and nuanced understanding of complex phenomena . Several strategies are used to enhance the internal validity of the quantitative part. At first, all questionnaires that will be used will be validated and selected after thorough consideration of several researchers with experience in mixed methods implementation research. Secondly, using a wide range of outcome indicators, increases the ability to distinguish confounding from independent variables. Thirdly, if possible a matched controlled group will be used to compare outcomes. Internal validity of qualitative data will be ensured in the stage of data collection by involving researchers who did not participate in the PAR-process to conduct the interviews and focus group interviews. In the stage of data analysis, internal validity of the qualitative data will be enhanced by systematically organizing and coding data and triangulation (data and researcher). Analysis and comparison of the four different settings will reinforce the external validity and transferability of the findings.
- Being tested
- Care provided by the Nurse Practitioner
- Keywords
- advanced practice nursing, interdisciplinary health team, participatory action research, longitudinal mixed methods study, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care provided by the Nurse PractitionerOther
Introduction of a Nurse Practitioner in the interdisciplinary care team
| Study group | Role | What they receive |
|---|---|---|
| Patient - cohort 1 | Patients (and their parents) recruited before introduction of the NP Receives: Other: Care provided by the Nurse Practitioner | |
| Patient - cohort 2 | Patients (and their parents) recruited after introduction of the NP Receives: Other: Care provided by the Nurse Practitioner | |
| Healthcare providers | Healthcare providers involved in the process of development, implementation and evaluation as well as all healthcare providers who come into close contact with the Nurse Practitioner Receives: Other: Care provided by the Nurse Practitioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of care NPSS - ambulatory
Satisfaction with NP/doctor consultation. The data will be collected by use of a questionnaire for patients (and their parents). Validated tools, the Nurse Practitioner Satisfaction Survey (NPSS) and the Quality of care through the patients eyes will be used.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in quality of care though the patients eyes - ambulatory liver cirrhosis
Satisfaction with NP/doctor consultation. The data will be collected by use of a questionnaire for patients (and their parents). A validated tool, the Quality of care through the patients eyes will be used.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in Quality of care (GS-PEQ) - hospitalization
Patient perception and experiences of quality of care provided during hospitalisation. The data will be collected by use of a questionnaire for patients. A validated tool the Generic Short Patient Experiences Questionnaire will be used.
Measured: The data will be collected at three points during the study: T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in Quality of care (Picker) - hospitalization
Patient perception and experiences of quality of care provided during hospitalisation. The data will be collected by use of a questionnaire for patients. A validated tool the Picker Patient Experience Questionnaire will be used.
Measured: The data will be collected at three points during the study: T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Secondary outcomes (15)
Change in hospital admissions - ambulatory
Number of hospital admissions for patients in ambulatory care. The data will be collected from the patients medical file.
Measured: All admissions one year before and after introduction will be registered. The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Length of stay hospital admissions - ambulatory
Length of stay in hospital for patients in ambulatory care. The data will be collected from the patients medical file.
Measured: Length of stay of all admissions 12 months before and 12 months after introduction of the Nurse practitioner will be registered.
Change in readmission - hospitalization
Readmission within seven days after discharge. The data will be collected from the patients medical file.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in mortality rates
Mortality rates of patients included in the study. The data will be collected from the patients medical file.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in pain Scores
Pain scores during hospitalization of surgical patients. The data will be collected from the patiënts medical file. Data will be registered from admission until dismissal.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in completeness of recording profile
Completeness of recording profile within 24h after admission will be registered. The data will be collected from the patients medical file.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in timely resignation letters
Availability of the resignation letter within 24h after admission will be registered. The data will be collected from the patients medical file.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in protocol adherence
Care provided after surgery will be compared to the ERAS-protocol. The data will be collected from the patients medical file.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in psychosocial conditions in workplaces
Psychosocial conditions in workplaces of healthcare providers. The data will be collected by use of a questionnaire for healthcare providers. A validated tool, the Copenhagen Psychosocial Questionnaire (COPSOQ III) will be used.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in team collaboration
Team effectiveness experienced by healthcare providers. The data will be collected by use of a questionnaire for healtcare providers. A validated tool, the Perceptions of Team Effectiveness (PTE) will be used.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in effectiveness of mentoring
Effectiveness of mentoring experienced by the Nurse practitioner and mentor of the Nurse practitioner. The data will be collected by use of individual interviews (mentor and trainee). Additionally data will be collected by use of a questionnaire for trainees. A validated tool, the mentorship effectiveness scale will be used.
Measured: The data will be collected at three points during the study: T1 (6 months after introduction) and T2 (1 year after introduction)
Number of medication prescriptions
Medication prescriptions before and after introduction of the nurse practitioner. The data will be collected from the patients medical file. Data will be registered from admission until dismissal.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in selfmanagement liver cirrhosis (HEIQ)
Knowledge, skills and confidence in selfmanagement. The data will be collected by use of a questionnaire for patients. Avalidated tools, Health Education Impact Questionnaire (HEIQ) for liver cirrhosis will be used.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in selfmanagement epilepsy medication (PEMSQ)
Knowledge, skills and confidence in selfmanagement. The data will be collected by use of a questionnaire for parents of patients. A validated tool, the Pediatric Epilepsy Medication Self-Management Questionnaire (PEMSQ), will be used.
Measured: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in bed occupancy rates
Bed occupancy rates at the ward before and after introduction of the nurse practitioner. The data will be collected from the administrative files.
Measured: he data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start17 May 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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 Nurse PractitionersStudies 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
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Frank Vermassen, MD, PhD, Principal investigator, Ghent University/Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520203
- Sponsor's protocol ID
- BC-09817
- Other IDs
- B6702021000685, B6702021000300, B6702021000479, B6702021000046
- Acronym
- NUPRA-DI
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dehennin L, Kinnaer LM, Vermassen F, Van Hecke A. Role development, implementation and evaluation of nurse practitioners in a Belgian university hospital: a mixed methods study protocol. BMJ Open. 2023 May 3;13(5):e068101. doi: 10.1136/bmjopen-2022-068101.
PubMed 37137560
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Development, Implementation and Evaluation of Nurse Practitioners in a Belgian University Hospital.
- ClinicalTrials.gov ID
- NCT05520203
- Acronym / sponsor ID
- NUPRA-DI / BC-09817
- Keywords
- advanced practice nursing, interdisciplinary health team, participatory action research, longitudinal mixed methods study, nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 17 May 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 29 Aug 2022 (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.
Hospitals face new challenges in providing sustainable high quality care as the prevalence of chronic conditions, multimorbidity and the complexity of care increases. The high burden on healthcare teams, the growing costs and the increasing scarcity in healthcare providers (HCPs) result in unmet needs of patients and their families and a high workload on HCPs. Worldwide there is growing recognition that new care models integrating nurse practitioners (NPs) in interdisciplinary teams could contribute to respond to these challenges.
ANP is defined as an "advanced practice nurse (APN) who integrates clinical skills associated with nursing and medicine in order to assess, diagnose and manage patients in primary healthcare settings and acute care populations as well as ongoing care for populations with chronic illness".
Despite the proven benefits of integrating NPs in interdisciplinary teams, the introduction of NPs in Belgium is at an early stage. Advanced practice nurses, including NPs, are formally recognized in Belgium since 2019, but there is still no legal framework in which additional rights or agreements compared to other nursing groups are defined. Given the early stage of introduction, little is known about the development, implementation and impact of NPs in the Belgian health care context. Insights in implementation processes and the effectiveness of NP roles at different levels can inform healthcare managers and policy makers for future (nation-wide) implementation in a hospital setting.
The overall objective of this longitudinal pre-post mixed methods study is to develop, implement and evaluate the integration of the role of NPs in four different departments in a Belgian university hospital.
Detailed description
A mixed methods design is used to enrich the gathered data, resulting in an integrated approach for addressing the complexity of this study. This method creates the opportunity to triangulate and integrate quantitative and qualitative data resulting in a complete and nuanced understanding of complex phenomena . Several strategies are used to enhance the internal validity of the quantitative part. At first, all questionnaires that will be used will be validated and selected after thorough consideration of several researchers with experience in mixed methods implementation research. Secondly, using a wide range of outcome indicators, increases the ability to distinguish confounding from independent variables. Thirdly, if possible a matched controlled group will be used to compare outcomes. Internal validity of qualitative data will be ensured in the stage of data collection by involving researchers who did not participate in the PAR-process to conduct the interviews and focus group interviews. In the stage of data analysis, internal validity of the qualitative data will be enhanced by systematically organizing and coding data and triangulation (data and researcher). Analysis and comparison of the four different settings will reinforce the external validity and transferability of the findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient - cohort 1 | – | Other: Care provided by the Nurse PractitionerPatients (and their parents) recruited before introduction of the NP |
| Patient - cohort 2 | – | Other: Care provided by the Nurse PractitionerPatients (and their parents) recruited after introduction of the NP |
| Healthcare providers | – | Other: Care provided by the Nurse PractitionerHealthcare providers involved in the process of development, implementation and evaluation as well as all healthcare providers who come into close contact with the Nurse Practitioner |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients - Patients (or their parents in the paediatric department) HCPs * Representatives of all relevant stakeholders (from each department) will be invited to participate (eg. head(s) of the medical department(s), physicians, physicians in training, (head) nurses, care managers, the chief medical officer, specialised nurses, social worker, pharmacist). * All HCPs who are currently involved in the care process of the targeted patient population.
Key inclusion criteria (5 listed)
- Admitted on the participating ward (digestive surgery) or diagnosed stable liver cirrhosis or pediatric epilepsy
- Be conscious
- Speak Dutch
- Have at least three months of clinical experience on the ward
- Key stakeholders in the process of development, implementation and/or evaluation
Key exclusion criteria (4 listed)
- Dementia or other severe cognitive/mental disorders
- Health care providers
- No contact with the nurse practitioner
- Internship
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 |
|---|---|---|
| Care provided by the Nurse PractitionerIntroduction of a Nurse Practitioner in the interdisciplinary care team | Other | Healthcare providers, Patient - cohort 1, Patient - cohort 2 |
Primary outcome
Change in quality of care NPSS - ambulatory
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Satisfaction with NP/doctor consultation. The data will be collected by use of a questionnaire for patients (and their parents). Validated tools, the Nurse Practitioner Satisfaction Survey (NPSS) and the Quality of care through the patients eyes will be used.
Change in quality of care though the patients eyes - ambulatory liver cirrhosis
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Satisfaction with NP/doctor consultation. The data will be collected by use of a questionnaire for patients (and their parents). A validated tool, the Quality of care through the patients eyes will be used.
Change in Quality of care (GS-PEQ) - hospitalization
Time frame: The data will be collected at three points during the study: T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Patient perception and experiences of quality of care provided during hospitalisation. The data will be collected by use of a questionnaire for patients. A validated tool the Generic Short Patient Experiences Questionnaire will be used.
Change in Quality of care (Picker) - hospitalization
Time frame: The data will be collected at three points during the study: T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Patient perception and experiences of quality of care provided during hospitalisation. The data will be collected by use of a questionnaire for patients. A validated tool the Picker Patient Experience Questionnaire will be used.
15 secondary outcomes
Change in hospital admissions - ambulatory
Time frame: All admissions one year before and after introduction will be registered. The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Length of stay hospital admissions - ambulatory
Time frame: Length of stay of all admissions 12 months before and 12 months after introduction of the Nurse practitioner will be registered.
Change in readmission - hospitalization
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in mortality rates
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in pain Scores
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in completeness of recording profile
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in timely resignation letters
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in protocol adherence
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in psychosocial conditions in workplaces
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in team collaboration
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in effectiveness of mentoring
Time frame: The data will be collected at three points during the study: T1 (6 months after introduction) and T2 (1 year after introduction)
Number of medication prescriptions
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in selfmanagement liver cirrhosis (HEIQ)
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in selfmanagement epilepsy medication (PEMSQ)
Time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in bed occupancy rates
Time frame: he data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 37137560Dehennin L, Kinnaer LM, Vermassen F, Van Hecke A. Role development, implementation and evaluation of nurse practitioners in a Belgian university hospital: a mixed methods study protocol. BMJ Open. 2023 May 3;13(5):e068101. doi: 10.1136/bmjopen-2022-068101.
- Individual participant dataSharing planned: No
Related trials for Nurse Practitioners
Recruiting
Psychoeducation Program for Family Caregivers Coordinated by an APRN
First Episode Psychosis (FEP), Caregiver Burden
Active, not recruiting
Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase
Long Term Cancer Side Effects, Supportive Care in Cancer
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.
Frank Vermassen, MD, PhD principal investigator
Ghent University/Ghent University Hospital
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 Nurse Practitioners and Implementation Research, run by University Hospital, Ghent at 2 sites in Belgium.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 21 Sep 2026. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of care NPSS - ambulatory (time frame: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)). The study lists 4 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 NCT05520203, 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 21 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.