PROMH2ONCT06833892
H2O-F - A PROSPECTIVE, MULTI-COUNTRY, MULTI-CENTRE, MULTI-CONDITION FEASIBILITY STUDY EVALUATING THE ESTABLISHMENT OF THE NATIONAL HEALTH OUTCOMES OBSERVATORY (H2O) ECOSYSTEM
An observational study of PROM, run by IRCCS San Raffaele at 1 site in Austria.
Trial summary
The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state. The study aims to systematically implement validated sets of PROMs (patient-reported outcomes) to enable real-time monitoring and intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PROM
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2023to 30 Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (>18 years of age) with a diagnosis of Type I or Type II Diabetes, Crohn's Disease, Ulcerative Colitis, Metastatic Breast Cancer, or Lung Cancer.
Who may be able to join
- Patients (>18 years of age) with a diagnosis of Type I or Type II Diabetes, Crohn's Disease, Ulcerative Colitis, Metastatic Breast Cancer, or Lung Cancer.
- Ability to read and understand the local language
- Participation in the H2O Registry (EK 1659/2022)
- Signed and dated informed consent form for participation in the feasibility study
- Willing and able to complete data collection using an electronic device.
Who cannot join
- Any patient who is unable or unwilling to provide explicit informed consent, or fails to meet other inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state.
The study aims to systematically implement validated sets of PROMs (patient-reported outcomes) to enable real-time monitoring and intervention, facilitating patient-centered health care.
Read the detailed description
This study is aimed to all patients with a diagnosis of Metastatic Breast Cancer, Lung Cancer, Crohn's Disease, Ulcerative Colitis or Type I and Type II Diabetes who are treated at participating MUW centers and other H2O stakeholders such as HCPs, healthcare administrators, healthcare policy makers, and academic and private sector researchers.
This is an international project that aims to systematically implement validated sets of PROMs (patient-reported outcomes) to enable real-time monitoring and intervention, facilitating patient-centered health care.
The sets of PROMs will be administered to patients during the clinical routine via online questionnaires.There are no additional procedures to the existing clinical routine.
The study includes a 6-month enrollment period and a 12-month observation period; questionnaires will be collected at baseline, 3, 6, 9, 12-month timepoints.
A total of 200 patients are expected to be enrolled among the various participating centers.
The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state.
The secondary objectives are to
- Measure the national Health Outcomes Observatory ecosystem's usability and utility for routine care delivery and secondary research health data use cases,
- Understand stakeholders' acceptance, identify facilitators and improve and deepen the situational, contextual qualitative understanding of the perceived barriers and challenges that could prevent implementation and scalability, and
- Evaluate the infrastructure established to capture, store, and analyse integrated clinical and patient-generated health outcome data.
- Conditions
- PROM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic BC, LC, Crohn's Disease, Ulcerative Colitis or Type I and Type II Diabetes | All patients with a diagnosis of Metastatic Breast Cancer, Lung Cancer, Crohn's Disease, Ulcerative Colitis or Type I and Type II Diabetes who are treated at participating MUW centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the progress of the national H2O Health Outcomes Observatory ecosystem
The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state using the Maturity Model
Measured: Data of each participant will be collected over a period of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jan 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: Study was denied by Italian Ethical Committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, Erasmus Medical Center, Charité University Hospital, Berlin, Germany, Vall d'Hebron University Hospital, Barcelona
- Responsible party
- Principal investigator, Alessandra Bulotta, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833892
- Sponsor's protocol ID
- H2O
- Acronym
- H2O
- Status last verified
- May 2025
- First submitted
- 13 Feb 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H2O-F - A PROSPECTIVE, MULTI-COUNTRY, MULTI-CENTRE, MULTI-CONDITION FEASIBILITY STUDY EVALUATING THE ESTABLISHMENT OF THE NATIONAL HEALTH OUTCOMES OBSERVATORY (H2O) ECOSYSTEM
- ClinicalTrials.gov ID
- NCT06833892
- Acronym / sponsor ID
- H2O / H2O
- Conditions
- PROM
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was denied by Italian Ethical Committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Medical University of Vienna, Erasmus Medical Center, Charité University Hospital, Berlin, Germany, Vall d'Hebron University Hospital, Barcelona
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Feb 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.
The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state.
The study aims to systematically implement validated sets of PROMs (patient-reported outcomes) to enable real-time monitoring and intervention, facilitating patient-centered health care.
Detailed description
This study is aimed to all patients with a diagnosis of Metastatic Breast Cancer, Lung Cancer, Crohn's Disease, Ulcerative Colitis or Type I and Type II Diabetes who are treated at participating MUW centers and other H2O stakeholders such as HCPs, healthcare administrators, healthcare policy makers, and academic and private sector researchers.
This is an international project that aims to systematically implement validated sets of PROMs (patient-reported outcomes) to enable real-time monitoring and intervention, facilitating patient-centered health care.
The sets of PROMs will be administered to patients during the clinical routine via online questionnaires.There are no additional procedures to the existing clinical routine.
The study includes a 6-month enrollment period and a 12-month observation period; questionnaires will be collected at baseline, 3, 6, 9, 12-month timepoints.
A total of 200 patients are expected to be enrolled among the various participating centers.
The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state.
The secondary objectives are to
- Measure the national Health Outcomes Observatory ecosystem's usability and utility for routine care delivery and secondary research health data use cases,
- Understand stakeholders' acceptance, identify facilitators and improve and deepen the situational, contextual qualitative understanding of the perceived barriers and challenges that could prevent implementation and scalability, and
- Evaluate the infrastructure established to capture, store, and analyse integrated clinical and patient-generated health outcome data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic BC, LC, Crohn's Disease, Ulcerative Colitis or Type I and Type II Diabetes | – | –All patients with a diagnosis of Metastatic Breast Cancer, Lung Cancer, Crohn's Disease, Ulcerative Colitis or Type I and Type II Diabetes who are treated at participating MUW centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (>18 years of age) with a diagnosis of Type I or Type II Diabetes, Crohn's Disease, Ulcerative Colitis, Metastatic Breast Cancer, or Lung Cancer.
Key inclusion criteria (5 listed)
- Patients (>18 years of age) with a diagnosis of Type I or Type II Diabetes, Crohn's Disease, Ulcerative Colitis, Metastatic Breast Cancer, or Lung Cancer.
- Ability to read and understand the local language
- Participation in the H2O Registry (EK 1659/2022)
- Signed and dated informed consent form for participation in the feasibility study
- Willing and able to complete data collection using an electronic device.
Key exclusion criteria (1 listed)
- Any patient who is unable or unwilling to provide explicit informed consent, or fails to meet other inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the progress of the national H2O Health Outcomes Observatory ecosystem
Time frame: Data of each participant will be collected over a period of 12 months.
The primary objective of this study is to assess the progress of the national H2O Health Outcomes Observatory ecosystem towards a fully functional and operational state using the Maturity Model
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by IRCCS San Raffaele at 1 site in Austria.
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 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: withdrawn, as of the sponsor's last update on 13 May 2025. 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 Austria. 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 was withdrawn before enrolling participants, so there are no results.
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?
To assess the progress of the national H2O Health Outcomes Observatory ecosystem (time frame: Data of each participant will be collected over a period of 12 months.). 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 13 May 2025.