H2O-F - A PROSPECTIVE, MULTI-COUNTRY, MULTI-CENTRE, MULTI-CONDITION FEASIBILITY STUDY EVALUATING THE ESTABLISHMENT OF THE NATIONAL HEALTH OUTCOMES OBSERVATORY (H2O) ECOSYSTEM
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To assess the progress of the national H2O Health Outcomes Observatory ecosystem
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Any patient who is unable or unwilling to provide explicit informed consent, or fails to meet other inclusion criteria.
结局指标
主要结局
To assess the progress of the national H2O Health Outcomes Observatory ecosystem
时间窗: 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
次要结局
未报告次要终点