Chronic Diseases in ChildrenPETRACANCT06679595
Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects
An observational study of Chronic Diseases in Children and Chronic Diseases in Adolescence, run by University Hospital, Ghent at 11 sites in Belgium.
Trial summary
The goal of this Realist Evaluation is to evaluate the implementation of pilot projects for transmural care in chronically ill children. The main question it aims to answer is: To what extent and how do the pilot projects for transmural care for chronically ill children provide an answer to the quintuple aim?… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Diseases in Children, Chronic Diseases in Adolescence, Health Personnel
- What is being tested?
- Pilot project paediatric transmural care
- How many people
- 1,000 participants
- Where
- 11 sitesBelgium
- Study dates
- 10 Sep 2024to 28 Feb 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The setting of the study is defined as the five pilot projects for paediatric transmural care, conducted by Belgian acute care hospitals in collaboration with primary care. These projects focus on transfusions of concentrated red blood cells at home, ventilation of children with a respiratory disease at home, home enzyme therapy by infusion for children suffering from lysosomal metabolic disease and early discharge of neonates with (partial) tube feeding. The study population consists of the people for whom the services offered by the pilot project are intended as defined in the implementation plan. This study population can be divided into four subgroups: the patients (children), their parents/legal guardians, healthcare professionals involved and the coordinators of the pilot projects.
Who may be able to join
- Children: any child up to the age of 18 participating in a pilot project for paediatric transmural care.
- Parent/Legal guardian: any parent or legal guardian of a child participating in a pilot project for paediatric transmural care
- Healthcare professionals: any healthcare professional with patient contact involved within a pilot project for paediatric transmural care
- Coordinators: all study and care coordinators involved within a pilot project for paediatric transmural care
Who cannot join
- No signed informed consent form available
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Belgium11 sites
Hôpital universitaire des enfants Reine Fabiola
Brussels, 1020
Cliniques Universitaires Saint-Luc
Brussels, 1200
Institut de Pathologie et de Génétique Charleroi
Charleroi, 6041
University Hospital Antwerp
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Universitair Ziekenhuis Brussel
Jette, 1090
Centre Hospitalier Jolimont-Lobbes
La Louvière, 7100
Universitaire Ziekenhuizen Leuven
Leuven, 3000
Centre Hospitalier Régional de la Citadelle
Liège, 4000
Centre Hospitaliere Universitaire de Liège
Liège, 4000
Clinique CHC MontLégia
Liège, 4000
About this study
The goal of this Realist Evaluation is to evaluate the implementation of pilot projects for transmural care in chronically ill children.
The main question it aims to answer is: To what extent and how do the pilot projects for transmural care for chronically ill children provide an answer to the quintuple aim?
Participants will
- Complete questionnaires at three timepoints
- Participate in focus group interviews
Read the detailed description
Introduction Chronic diseases have been increasing over the past few years, including in children. The chronic condition affects their daily functioning and quality of life and leads to frequent hospital admissions. To avoid unneccessary hospital admissions and to offer alternative and innovative forms of care, the Belgian Federal Public Service of Public Health, Food Chain Safety and Environment selected five pilot projects for transmural care for chronically ill children. This study was designed to evaluate these projects.
Methods and design The overall approach is a two-year longitudinal prospective Realist Evaluation using a mixed-methods design.
The quantitative strand, using routine data and questionnaires, will examine whether data from children, parents/legal guardians and healthcare professionals involved in a pilot project for paediatric transmural care comply with the quintuple aim outcomes.
The qualitative strand will be used (1) to evaluate the structure of the interventions, (2) for process evaluation and context analysis, and (3) to gather more in-depth information. This includes document analysis (including logbooks), focus groups with children, parents/legal guardians and healthcare professionals, and non-participatory observations.
Ethical Informed consent is required prior to inclusion in the evaluation study. Informed assent is requested from children older than 12 years. For this study, advice is asked from the Research Ethics Committee of Ghent University Hospital
- Being tested
- Pilot project paediatric transmural care
- Keywords
- Realist Evaluation, Chronic Disease, Child, Adolescent, Infant, Home Care Services, Hospital-Based
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot project paediatric transmural careOther
The implementation of pilot projects for transmural care for chronically ill children
| Study group | Role | What they receive |
|---|---|---|
| Children | Children up to the age of 18 with a chronic condition included in a pilot project for paediatric transmural care Receives: Other: Pilot project paediatric transmural care | |
| Parents | Parents/ legal guardians of children included in a pilot project for paediatric transmural care Receives: Other: Pilot project paediatric transmural care | |
| Healthcare professionals | Project coordinators and healtcare professionals involved in a pilot project for paediatric transmural care Receives: Other: Pilot project paediatric transmural care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Quality of Life is used as an indicator for the aim "health status". The PedsQL (Paediatric Quality of Life Inventory) 4.0 Generic Core Scales is used to measure health-related quality of life in children and adolescents ages 2 to 18.
The scale consists of 23 items and has a child self-report and parallel proxy-report format for ages 5-7, 8-12 and 13-18 years. The items are scored on a five-point Likert-scale, ranging from "never a problem" to "almost always a problem";.
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Parental Quality of Life
Quality of Life is used as an indicator for the aim "health status". To estimate parent's quality of life, the take care tool (4 domains, 16 items) is used. The items are scored on a three-point Likert-scale, ranging from "Satisfied" to "Not satisfied".
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Caregiver burden
Caregiver burden is used as an indicator for the aim "health status". The 4-item version of the Zarit Burden Interview is used to estimate the caregiver burden for the parents. The items are scored on a five-point Likert-scale, ranging from "Never" tot "Nearly Always"
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Diagnosis
The diagnosis and date of diagnosis of the participant are collected as an indicator for the aim "health status".
These data will be extracted from the (electronic) patient records.
Measured: Through study completion, up to 18 months maximum.
Length of stay in the hospital
The length of stay in the hospital, prior to the start of the transmural care of the participant are collected as an indicator for the aim "health status".
These data will be extracted from the (electronic) patient records.
Measured: Through study completion, up to 18 months maximum.
Length of stay in transmural care
The length of stay in transmural care, measured by counting the total number of days each child receives this care, is an indicator for the aim "health status".
These data will be extracted from the (electronic) patient records.
Measured: Through study completion, up to 18 months maximum.
Transmural care at school
If transmural care has been given at school, was evaluated as an indicator for the aim "health status".
These data will be extracted from the (electronic) patient records.
Measured: Through study completion, up to 18 months maximum.
Adverse events
Adverse events are logged as an indicator for the aims "health status" and "quality of care".
Adverse events are continuously logged by the project coordinators in a self-developed questionnaire.
Measured: Continuous data collection, until study completion (18 months)
Patient experience
Patient experience is used as an indicator for the aim "quality of care". Patient experience is measured among children (or by proxy under the age of 8) and among their parents. To avoid lengthy statements, a questionnaire was developed by the researchers for this purpose. The items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Parental Empowerment
Parental empowerment is used as an indicator for the aim "quality of care". Patient empowerment is the patient's ability to have control over their health and their ability to be involved in care. In paediatrics, parents advocate strongly for what they feel is best for their child and family and want to feel they are able to make disicions. Therefore, the empowerment of parents is questioned.
A questionnaire was developed by the researchers for this purpose. The items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Job Satisfaction
Job Satisfaction is used as an indicator for the aim "value healthcare professionals".
The Michigan Organizational Assessment Questionnaire Job Satisfaction Subscale (MOAQ-JSS) is used to measure job satisfaction among the healthcare professionals involved. The three items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Work-related stress
Work-related stress is used as an indicator for the aim "value healthcare professionals".
Work-related stress is measured using a single question developed by the researchers. The item is scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".
Measured: Baseline, 6 months and through study completion, up to 18 months maximum .
Quality of Work
Quality of Work is used as an indicator for the aim "value healthcare professionals".
The dimension Quality of Work of the COPSOQ II is used to measure the experience by the healthcare professional of the immediate output of work. The two items are scored on a five-point Likert-scale, ranging from "To a very large extent" to "To a very small extent".
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Competence and Training
Competence and Training is used as an indicator for the aim "value healthcare professionals".
It is important that the healthcare professional providing care at home with children has solid paediatric competencies and experience. Competence and training are questioned among healthcare professionals, using a self-developed questionnaire.
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Socio-demographic variables
Socio-demographic variables are used as an indicator for the aim "equity and inclusion".
These variables are questioned among parents and healthcare professionals.
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Socio-economic variables
Socio-economic variables are used as an indicator for the aim "equity and inclusion".
Financial status, education, employment status and productivity loss based on the iCPQ are questioned among parents.
Measured: Baseline, 6 months and through study completion, up to 18 months maximum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start10 Sep 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (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 Chronic Diseases in ChildrenStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle, Centre Hospitalier Jolimont-Lobbes, University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Centre Hospitalier Universitaire de Liege, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Universitair Ziekenhuis Brussel, Institut de Pathologie et de Génétique Charleroi, CHC Montlegia, Hôpital universitaire des enfant Reine Fabiola
- Responsible party
- Sponsor
- Investigators
- Sabine Van daele, Prof. dr., Principal investigator, University Hospital, GhentVeerle Duprez, dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679595
- Sponsor's protocol ID
- B670204000193
- Acronym
- PETRACA
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dequeker S, Vanderwee K, Van Daele S, Duprez V; PETRACA Study Group. Realist evaluation of Belgian pilot projects for paediatric transmural care: protocol for a mixed methods study. BMJ Open. 2025 Jun 25;15(6):e102152. doi: 10.1136/bmjopen-2025-102152.
PubMed 40562551
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects
- ClinicalTrials.gov ID
- NCT06679595
- Acronym / sponsor ID
- PETRACA / B670204000193
- Keywords
- Realist Evaluation, Chronic Disease, Child, Adolescent, Infant, Home Care Services, Hospital-Based
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle, Centre Hospitalier Jolimont-Lobbes, University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Centre Hospitalier Universitaire de Liege, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Universitair Ziekenhuis Brussel, Institut de Pathologie et de Génétique Charleroi, CHC Montlegia, Hôpital universitaire des enfant Reine Fabiola
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 7 Nov 2024 (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.
The goal of this Realist Evaluation is to evaluate the implementation of pilot projects for transmural care in chronically ill children.
The main question it aims to answer is: To what extent and how do the pilot projects for transmural care for chronically ill children provide an answer to the quintuple aim?
Participants will
- Complete questionnaires at three timepoints
- Participate in focus group interviews
Detailed description
Introduction Chronic diseases have been increasing over the past few years, including in children. The chronic condition affects their daily functioning and quality of life and leads to frequent hospital admissions. To avoid unneccessary hospital admissions and to offer alternative and innovative forms of care, the Belgian Federal Public Service of Public Health, Food Chain Safety and Environment selected five pilot projects for transmural care for chronically ill children. This study was designed to evaluate these projects.
Methods and design The overall approach is a two-year longitudinal prospective Realist Evaluation using a mixed-methods design.
The quantitative strand, using routine data and questionnaires, will examine whether data from children, parents/legal guardians and healthcare professionals involved in a pilot project for paediatric transmural care comply with the quintuple aim outcomes.
The qualitative strand will be used (1) to evaluate the structure of the interventions, (2) for process evaluation and context analysis, and (3) to gather more in-depth information. This includes document analysis (including logbooks), focus groups with children, parents/legal guardians and healthcare professionals, and non-participatory observations.
Ethical Informed consent is required prior to inclusion in the evaluation study. Informed assent is requested from children older than 12 years. For this study, advice is asked from the Research Ethics Committee of Ghent University Hospital
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children | – | Other: Pilot project paediatric transmural careChildren up to the age of 18 with a chronic condition included in a pilot project for paediatric transmural care |
| Parents | – | Other: Pilot project paediatric transmural careParents/ legal guardians of children included in a pilot project for paediatric transmural care |
| Healthcare professionals | – | Other: Pilot project paediatric transmural careProject coordinators and healtcare professionals involved in a pilot project for paediatric transmural care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The setting of the study is defined as the five pilot projects for paediatric transmural care, conducted by Belgian acute care hospitals in collaboration with primary care. These projects focus on transfusions of concentrated red blood cells at home, ventilation of children with a respiratory disease at home, home enzyme therapy by infusion for children suffering from lysosomal metabolic disease and early discharge of neonates with (partial) tube feeding. The study population consists of the people for whom the services offered by the pilot project are intended as defined in the implementation plan. This study population can be divided into four subgroups: the patients (children), their parents/legal guardians, healthcare professionals involved and the coordinators of the pilot projects.
Key inclusion criteria (4 listed)
- Children: any child up to the age of 18 participating in a pilot project for paediatric transmural care.
- Parent/Legal guardian: any parent or legal guardian of a child participating in a pilot project for paediatric transmural care
- Healthcare professionals: any healthcare professional with patient contact involved within a pilot project for paediatric transmural care
- Coordinators: all study and care coordinators involved within a pilot project for paediatric transmural care
Key exclusion criteria (1 listed)
- No signed informed consent form available
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 |
|---|---|---|
| Pilot project paediatric transmural careThe implementation of pilot projects for transmural care for chronically ill children | Other | Children, Healthcare professionals, Parents |
Primary outcome
Quality of Life
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Quality of Life is used as an indicator for the aim "health status". The PedsQL (Paediatric Quality of Life Inventory) 4.0 Generic Core Scales is used to measure health-related quality of life in children and adolescents ages 2 to 18. The scale consists of 23 items and has a child self-report and parallel proxy-report format for ages 5-7, 8-12 and 13-18 years. The items are scored on a five-point Likert-scale, ranging from "never a problem" to "almost always a problem";.
Parental Quality of Life
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Quality of Life is used as an indicator for the aim "health status". To estimate parent's quality of life, the take care tool (4 domains, 16 items) is used. The items are scored on a three-point Likert-scale, ranging from "Satisfied" to "Not satisfied".
Caregiver burden
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Caregiver burden is used as an indicator for the aim "health status". The 4-item version of the Zarit Burden Interview is used to estimate the caregiver burden for the parents. The items are scored on a five-point Likert-scale, ranging from "Never" tot "Nearly Always"
Diagnosis
Time frame: Through study completion, up to 18 months maximum.
The diagnosis and date of diagnosis of the participant are collected as an indicator for the aim "health status". These data will be extracted from the (electronic) patient records.
Length of stay in the hospital
Time frame: Through study completion, up to 18 months maximum.
The length of stay in the hospital, prior to the start of the transmural care of the participant are collected as an indicator for the aim "health status". These data will be extracted from the (electronic) patient records.
Length of stay in transmural care
Time frame: Through study completion, up to 18 months maximum.
The length of stay in transmural care, measured by counting the total number of days each child receives this care, is an indicator for the aim "health status". These data will be extracted from the (electronic) patient records.
Transmural care at school
Time frame: Through study completion, up to 18 months maximum.
If transmural care has been given at school, was evaluated as an indicator for the aim "health status". These data will be extracted from the (electronic) patient records.
Adverse events
Time frame: Continuous data collection, until study completion (18 months)
Adverse events are logged as an indicator for the aims "health status" and "quality of care". Adverse events are continuously logged by the project coordinators in a self-developed questionnaire.
Patient experience
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Patient experience is used as an indicator for the aim "quality of care". Patient experience is measured among children (or by proxy under the age of 8) and among their parents. To avoid lengthy statements, a questionnaire was developed by the researchers for this purpose. The items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".
Parental Empowerment
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Parental empowerment is used as an indicator for the aim "quality of care". Patient empowerment is the patient's ability to have control over their health and their ability to be involved in care. In paediatrics, parents advocate strongly for what they feel is best for their child and family and want to feel they are able to make disicions. Therefore, the empowerment of parents is questioned. A questionnaire was developed by the researchers for this purpose. The items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".
Job Satisfaction
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Job Satisfaction is used as an indicator for the aim "value healthcare professionals". The Michigan Organizational Assessment Questionnaire Job Satisfaction Subscale (MOAQ-JSS) is used to measure job satisfaction among the healthcare professionals involved. The three items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".
Work-related stress
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum .
Work-related stress is used as an indicator for the aim "value healthcare professionals". Work-related stress is measured using a single question developed by the researchers. The item is scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".
Quality of Work
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Quality of Work is used as an indicator for the aim "value healthcare professionals". The dimension Quality of Work of the COPSOQ II is used to measure the experience by the healthcare professional of the immediate output of work. The two items are scored on a five-point Likert-scale, ranging from "To a very large extent" to "To a very small extent".
Competence and Training
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Competence and Training is used as an indicator for the aim "value healthcare professionals". It is important that the healthcare professional providing care at home with children has solid paediatric competencies and experience. Competence and training are questioned among healthcare professionals, using a self-developed questionnaire.
Socio-demographic variables
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Socio-demographic variables are used as an indicator for the aim "equity and inclusion". These variables are questioned among parents and healthcare professionals.
Socio-economic variables
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Socio-economic variables are used as an indicator for the aim "equity and inclusion". Financial status, education, employment status and productivity loss based on the iCPQ are questioned among parents.
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 7 Nov 2024.
- Derived from this study: PubMed 40562551Dequeker S, Vanderwee K, Van Daele S, Duprez V; PETRACA Study Group. Realist evaluation of Belgian pilot projects for paediatric transmural care: protocol for a mixed methods study. BMJ Open. 2025 Jun 25;15(6):e102152. doi: 10.1136/bmjopen-2025-102152.
- Individual participant dataSharing planned: Undecided
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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.
Sabine Van daele, Prof. dr. principal investigator
University Hospital, Ghent
Veerle Duprez, dr. principal investigator
University Hospital, Ghent
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diseases in Children and Chronic Diseases in Adolescence, run by University Hospital, Ghent at 11 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 4 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: enrolling by invitation, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
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?
Quality of Life (time frame: Baseline, 6 months and through study completion, up to 18 months maximum.). The study lists 16 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 NCT06679595, 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 7 Nov 2024.