H2O-F - A PROSPECTIVE, MULTI-COUNTRY, MULTI-CENTRE, MULTI-CONDITION FEASIBILITY STUDY EVALUATING THE ESTABLISHMENT OF THE NATIONAL HEALTH OUTCOMES OBSERVATORY (H2O) ECOSYSTEM (H2O)

May 8, 2025 updated by: Alessandra Bulotta, IRCCS San Raffaele

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any patient who is unable or unwilling to provide explicit informed consent, or fails to meet other inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Data of each participant will be collected over a period of 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Raffaele

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Vienna
Erasmus Medical Center
Charité University Hospital, Berlin, Germany
Vall d'Hebron University Hospital, Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H2O

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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