NCT06591988

Brief Summary

This study is part of the MISTRAL project, funded by the European Commission under the Horizon Europe Program, within the Work Programme 2021-2022 of Pillar II - Health Cluster on Environment and Health, which has the main objective of creating a cloud-based informatics platform for Health Impact Assessment analysis that, thanks to artificial intelligence, is able to simulate different clinical scenarios, economic and social, before and after the introduction of environmental risk mitigation policies, starting from data and evidence derived from case studies (several European cities) with different levels of exposure to environmental, health, geographical and socio-economic factors. The Project involves 11 partners distributed among Italy (Istituto Superiore di Sanità, Azienda Sanitaria Locale di Taranto, University of Bari, Politecnico di Bari, APS PLANET), Belgium (University of Hasselt), Poland (AGH-University of Technology and Science), Germany (Nuromedia), Spain (Ubitel), Greece (WINGS-ICT Solutions) and England (University of Oxford, University of Suffolk). Specifically, the ZEPHYR study is a cross-sectional (cross-sectional), population-based, multicenter survey. The centers involved are the ASL of Taranto with the Taranto City Single District (Coordinating Recruitment Center), the University of Hasselt, Belgium (Recruitment Center Hasselt Hospital Campus), and the University of Krakow, Poland (Rybnik University Hospital as recruitment center).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
608

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

September 1, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 9, 2024

Last Update Submit

September 11, 2024

Conditions

Keywords

environmental pollutantslifestylemortalityrisk factorspublic healthlife expectancy

Outcome Measures

Primary Outcomes (2)

  • QALY

    quality-adjusted life-year. QALY scores range from 1 (perfect health) to 0 (dead)

    baseline and 2 years

  • DALY

    Disability Adjusted Life Years. Disability-adjusted life years (DALYs) are a measure of overall disease burden, expressed as the number of years lost due to ill-health, disability, or early death.

    baseline and 2 years

Interventions

introduction of environmental risk mitigation policies, from data and evidence from case studies (several European cities) with different levels of exposure to environmental, health, geographic, and socioeconomic factors.

Also known as: environmental risk mitigation policies

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The sampling frame will consist of the demographic dataset from regional health registries for each national unit. The survey will include children, adults, and the elderly, and probability sampling will be applied in each subpopulation, using a nearest neighbor matching algorithm and considering sex and age classes (5-year intervals) as matching covariates.

You may qualify if:

  • Within the population of Taranto (southern Italy), healthy volunteer subjects will be recruited, and sampled from the following geographic areas of the city: the Tamburi district (an area presumably highly exposed to environmental pollutants), and the Talsano-Lama-San Vito district.

You may not qualify if:

  • unhealthy subjects
  • Taranto people residing outside the above areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Health Authority of Taranto

Taranto, 74121, Italy

Location

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Days
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

September 1, 2024

Primary Completion

April 1, 2025

Study Completion

October 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations