NCT06833892

Brief 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, facilitating patient-centered health care.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
5mo left

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2023Sep 2026

Study Start

First participant enrolled

January 1, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

February 13, 2025

Last Update Submit

May 8, 2025

Conditions

PROM

Outcome Measures

Primary Outcomes (1)

  • 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

    Data of each participant will be collected over a period of 12 months.

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 19, 2025

Study Start

January 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

AU(1)