Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches

NCT03503812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2023-02-16

No results posted yet for this study

Summary

The MEDEA project is envisioned to provide the field-based evidence for the adoption of a strategic plan for mitigating the health effects of desert dust storm (DDS) events in South-Eastern Europe. Over the past decade, several studies have demonstrated that DDS in Mediterranean countries, originating mostly from the Sahara and Arabian Peninsula deserts, have been increasing in number and magnitude and linked it to desertification, climatic variability and global warming. EU legislation considers DDS impossible to prevent, implicitly harmless and discounts their contribution to daily and annual air quality standards of particulate matter up to 10 microns (PM10). However, there is increasing evidence from epidemiological studies, which correlates exposure to PM10 during DDS with a significant increase in mortality and hospital admissions from cardiovascular and respiratory causes. Therefore, there is a pressing need for EU policies to reduce population exposures and increase individual, population and institutional resilience to the growing frequency and intensity of DDS. MEDEA ultimate goal is to demonstrate the feasibility and effectiveness of an adaptation strategy to DDS and better inform EU policy making. The adaptation strategy will be carried out within two panel studies, with two different groups of patients; 1. Children with asthma and 2. Adults with atrial fibrillation (AF). The primary objective will be to quantify the vulnerability of children with asthma and adults with AF during DDS outbreaks and provide evidence-based estimates demonstrating which interventions/recommendations work best in mitigating adverse health effects in this group of patients after randomization of each group of patients to three parallel intervention groups: a) No intervention for DDS; b) Intervention for outdoor exposure reduction, and c) Interventions for both outdoor and indoor exposure reduction. The secondary objective of the study is to demonstrate which of the recommendations are effective in reducing outdoor and indoor exposures to DDS in a panel of children with asthma and in a panel of AF adults.

Intervention: Each group of patients (children with asthma and AF patients) will be recruited and will be randomized during the high DDS outbreaks season (Spring 2019 and 2020) with 1:1:1 ratio into three parallel groups to receive: a) No intervention for DDS; b) Intervention for outdoor exposure reduction, by reducing the time spend outdoors and by avoiding physical activity and c) Interventions for outdoor (as above) and indoor exposure reduction (by minimizing home ventilation and filtering indoor air). Disease-related adverse health outcomes will be assessed in the three parallel arms of the study.

Approaches for delivering the intervention: A bidirectional, patient-centered e-Platform will be developed in order to facilitate prompt communication with the participants and provide early warnings regarding forecasted upcoming DDS events through text messaging and smartphone applications. Furthermore, the same IT platform and mobile application will be utilised for the dissemination of the exposure reduction guidelines that the participants will follow.

Assessment of adherence to intervention: 1.Monitor compliance to exposure-reduction guidelines using remote sensors. The intervention for outdoor exposure reduction, entailing reduction of the time spend outdoors and avoidance of physical activity, will be assessed with the use of smart wristwatches that will be equipped with Global Positioning System (GPS) and an accelerometer. 2.The intervention for indoor exposure reduction, entailing minimization of home ventilation and filtering of indoor air, will be assessed with the use of particle samplers that will be placed outside and inside of houses and school classrooms.

Conditions

Interventions

BEHAVIORAL

Intervention (1) for outdoor exposure reduction - Asthma in Children

Intervention 1 (I1) aims to reduce exposure to outdoor particles and it will be applied on days with DDS during the follow-up period. This intervention will consist of two recommendations: 1. Reduce time spent outdoors and 2. Reduce physical activity

BEHAVIORAL

Intervention (2) for outdoor and indoor exposure reduction - Asthma in Children

Intervention 2 (I2) aims to reduce both: i) exposure to outdoor particles and it will be applied on days with DDS during the follow-up period. This intervention will consist of two recommendations: 1. Reduce time spent outdoors and 2. Reduce physical activity ii) indoor particle levels on a continuous daily basis throughout the follow-up DDS period. This intervention will consist of two recommendations for participants' schools and houses: 3. Reduce particle infiltration into residences by keeping windows and doors closed as much as possible and 4. Reduce indoor particle levels by using air cleaners.

BEHAVIORAL

Intervention (1) for outdoor exposure reduction - Atrial Fibrillation

Intervention 1 (I1) aims to reduce exposure to outdoor particles and it will be applied on days with DDS during the follow-up period. This intervention will consist of two recommendations: 1. Reduce time spent outdoors and 2. Reduce physical activity

BEHAVIORAL

Intervention (2) for outdoor and indoor exposure reduction - Atrial Fibrillation

Intervention 2 (I2) aims to reduce both: i) exposure to outdoor particles and it will be applied on days with DDS during the follow-up period. This intervention will consist of two recommendations: 1. Reduce time spent outdoors and 2. Reduce physical activity ii) indoor particle levels on a continuous daily basis throughout the follow-up DDS period. This intervention will consist of two recommendations for participants' houses: 3. Reduce particle infiltration into residences by keeping windows and doors closed as much as possible and 4. Reduce indoor particle levels by using air cleaners.

Sponsors & Collaborators

  • University of Crete

    collaborator OTHER
  • Soroka University Medical Center

    collaborator OTHER
  • Cyprus University of Technology

    collaborator OTHER
  • Department of Labor Inspection, Ministry of Labor, Welfare and Social Insurance, Cyprus

    collaborator UNKNOWN
  • Department of Meteorology, Ministry of Agriculture, Rural Development and Environment, Cyprus

    collaborator UNKNOWN
  • Cyprus Broadcasting Corporation

    collaborator UNKNOWN
  • E.n.A Consulting LP

    collaborator UNKNOWN
  • University of Cyprus

    lead OTHER

Principal Investigators

  • Panayiotis Yiallouros, MD, PhD · Medical School, University of Cyprus

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Cyprus
  • Greece
  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503812 on ClinicalTrials.gov