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

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ClinicalTrials.gov Identifier: NCT03503812
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
University of Crete
Soroka University Medical Center
Cyprus University of Technology
Cyprus Department of Labor Inspection
Cyprus Department of Meteorology
Cyprus Broadcasting Corporation
E.n.A Consulting LP
Information provided by (Responsible Party):
Panayiotis Yiallouros, University of Cyprus

Brief 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.


Condition or disease Intervention/treatment Phase
Asthma in Children Atrial Fibrillation Behavioral: Intervention (1) for outdoor exposure reduction - Asthma in Children Behavioral: Intervention (2) for outdoor and indoor exposure reduction - Asthma in Children Behavioral: Intervention (1) for outdoor exposure reduction - Atrial Fibrillation Behavioral: Intervention (2) for outdoor and indoor exposure reduction - Atrial Fibrillation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Following the eligibility assessment, we will randomize each group of participants (group with asthmatic children and group with AF patients) with a 1:1:1 ratio to 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, c) interventions for outdoor (as above) and indoor exposure reduction (by minimizing home ventilation and filtering indoor air). In the indoor intervention arm of the study, exposure reduction measures will be applied in the asthmatic child's classroom/school and bedroom/household settings and in the AF patient's household/bedroom settings. The study design offers also the opportunity to assess: 1.outdoor exposures to PM, and 2.indoor exposures to PM and related health outcomes in three parallel groups during the same DDS events with and without intervention measures.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches: Assessment of Health Outcomes in Children With Asthma and in Adults With Atrial Fibrillation During Desert Dust Storms (With vs Without Interventions)
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No intervention to DDS exposure - Asthma in Children
Experimental: Intervention 1 - Asthma in Children 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 4-month period. This intervention will consist of two recommendations:

  1. Reduce time spent outdoors and
  2. Reduce physical activity

Experimental: Intervention 2 - Asthma in Children 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 4-month 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 4-month 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.

No Intervention: No intervention to DDS exposure - Atrial Fibrillation
Experimental: Intervention 1 - Atrial Fibrillation 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 4-month period. This intervention will consist of two recommendations:

  1. Reduce time spent outdoors and
  2. Reduce physical activity

Experimental: Intervention 2 - Atrial Fibrillation 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 4-month 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 4-month 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.




Primary Outcome Measures :
  1. Comparison of Asthma Control Test (ACT) questionnaire score between the no intervention group and the intervention groups in asthmatic children during the high DDS period of 2019 [ Time Frame: 4 months ]
    An improvement of more than 3 points in the ACT or an ACT score>=20 during the high DDS period will be considered. The ACT is a 5-item patient-based assessment that measures dimensions of asthma control. Each item is assessed on a 5-point scale. The scores are summed to give a total score ranging from 5-25. A score of>=20 denotes 'well-controlled asthma', a score of 16-19 denotes 'not well-controlled asthma', and a score of<=15 denotes 'very poorly controlled asthma'. Each month, the combined effect of the ACT will be compared in the two intervention groups vs. the no intervention group. Next, investigators will compare between each of the intervention groups and no intervention group and between the intervention groups. A validated-Greek ACT will be performed via phone interviews at baseline and then at every 1 month during the high DDS period. The frequency of respiratory symptoms will be assessed via child's responses to questions on daytime-night-time symptoms in the past 4 weeks

  2. Comparison of Asthma Control Test (ACT) questionnaire score between the no intervention group and the intervention groups in asthmatic children during the high DDS period of 2020 [ Time Frame: 4 months ]
    An improvement of more than 3 points in the ACT or an ACT score>=20 during the high DDS period will be considered. The ACT is a 5-item patient-based assessment that measures dimensions of asthma control. Each item is assessed on a 5-point scale. The scores are summed to give a total score ranging from 5-25. A score of>=20 denotes 'well-controlled asthma', a score of 16-19 denotes 'not well-controlled asthma', and a score of<=15 denotes 'very poorly controlled asthma'. Each month, the combined effect of the ACT will be compared in the two intervention groups vs. the no intervention group. Next, investigators will compare between each of the intervention groups and no intervention group and between the intervention groups. A validated-Greek ACT will be performed via phone interviews at baseline and then at every 1 month during the high DDS period. The frequency of respiratory symptoms will be assessed via child's responses to questions on daytime-night-time symptoms in the past 4 weeks

  3. Comparison of the number and duration of high atrial frequency episode between the no intervention group and the intervention groups in adults with AF during the high DDS period of 2019. [ Time Frame: 4 months ]
    AF burden is defined as the overall time percentage with AF during the observed period. An AF episode is considered every detected high atrial frequency episode of >330 ms (180 beats per minute) lasting for longer than 30 s with an atrial sensitivity of 0.5 mV. For the primary analysis, the investigators will compare the combined effect in the two intervention groups versus the no intervention (control) group. Secondarily, the effectiveness of each intervention will be compared versus the no intervention (control group) and to each other.

  4. Comparison of the number and duration of high atrial frequency episode between the no intervention group and the intervention groups in adults with AF during the high DDS period of 2020. [ Time Frame: 4 months ]
    AF burden is defined as the overall time percentage with AF during the observed period. An AF episode is considered every detected high atrial frequency episode of >330 ms (180 beats per minute) lasting for longer than 30 s with an atrial sensitivity of 0.5 mV. For the primary analysis, the investigators will compare the combined effect in the two intervention groups versus the no intervention (control) group. Secondarily, the effectiveness of each intervention will be compared versus the no intervention (control group) and to each other.


Secondary Outcome Measures :
  1. Comparison of the secondary outcome measures between the no intervention group and the 2 intervention groups during the high DDS period of 2019 [ Time Frame: 4 months ]
    Secondary outcome measures: presence or absence of asthma symptoms in the prior 4-week period, asthma medication use, unscheduled visits for asthma, forced expiratory volume in 1 second, peak expiratory flow, and FeNO

  2. Comparison of the secondary outcome measures between the no intervention group and the 2 intervention groups during the high DDS period of 2020 [ Time Frame: 4 months ]
    Secondary outcome measures: presence or absence of asthma symptoms in the prior 4-week period, asthma medication use, unscheduled visits for asthma, forced expiratory volume in 1 second, peak expiratory flow, and FeNO

  3. Comparison of secondary outcome measures between the no intervention group and the intervention groups in adults with AF during the high DDS period of 2019. [ Time Frame: 4 months ]
    Secondary outcome measures: occurrence of the ventricular arrythmias (assessed through the pacemaker) and heart rate variability

  4. Comparison of secondary outcome measures between the no intervention group and the intervention groups in adults with AF during the high DDS period of 2020. [ Time Frame: 4 months ]
    Secondary outcome measures: occurrence of the ventricular arrythmias (assessed through the pacemaker) and heart rate variability



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Children with asthma:

The inclusion criteria for this panel study will be children with physician-diagnosed asthma for at least one year and with at least one of the following:

  • Anti-asthma medication in the past year,
  • Wheezing in the past year, or
  • An unscheduled medical visit for asthma in the past year.

Exclusion Criteria for Children with asthma:

The exclusion criteria will be:

  • Lung disease other than asthma
  • Cardiovascular disease
  • Not living at least 5 days per week in the household

Inclusion Criteria for AF patients:

The inclusion criteria for this panel study will be patients with permanent dual lead (atrial and ventricular) pacemaker or ICD implanted at least two months prior to randomization, with:

  • A history of AF or
  • Detection of AF in pacemaker/ICD monitoring

Exclusion Criteria for AF patients:

The exclusion criteria will be:

  • Permanent AF
  • Patients with reversible causes of AF (eg hyperthyroidism)
  • Inability to understand and use study tools (smartphones, software applications)
  • Terminal illness
  • Active smoking
  • Not living at least 5 days per week in the household.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503812


Contacts
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Contact: Panayiotis Kouis, PhD 0035722895243 kouis.panayiotis@ucy.ac.cy
Contact: Maria Kakkoura, PhD 0035722895243 kakkoura.maria@ucy.ac.cy

Locations
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Cyprus
Medical School, University of Cyprus Recruiting
Nicosia, Aglantzia, Cyprus, 2029
Contact: Panayiotis Kouis, PhD    0035722895243    kouis.panayiotis@ucy.ac.cy   
Greece
School of Medicine, University of Crete Recruiting
Heraklion, Crete, Greece, GR-71003
Contact: Eleni Michailidi, MD, PhD    00306976423932    miheni@otenet.gr   
Israel
Soroka University Medical Center Recruiting
Be'er Sheva, Israel, 84101
Contact: Elinor Weingarten-Kenan    00972-8-6403116    elinorwe@clalit.org.il   
Sponsors and Collaborators
University of Cyprus
University of Crete
Soroka University Medical Center
Cyprus University of Technology
Cyprus Department of Labor Inspection
Cyprus Department of Meteorology
Cyprus Broadcasting Corporation
E.n.A Consulting LP
Investigators
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Principal Investigator: Panayiotis Yiallouros, MD, PhD Medical School, University of Cyprus
  Study Documents (Full-Text)

Documents provided by Panayiotis Yiallouros, University of Cyprus:
Statistical Analysis Plan  [PDF] April 3, 2018

Publications:
Gerasopoulos E, et al. Origin and variability of particulate matter (PM10) mass concentrations over the Eastern Mediterranean. Atmos Environ 2006; 40:4679-4690.
Querol X, et al. African dust contributions to mean ambient PM10 mass-levels across the Mediterranean, Basin. Atmos Environ 2009; 43:4266-4277
Vodonos A, et al. The impact of desert dust exposures on hospitalizations due to exacerbation of chronic obstructive pulmonary disease. Air Qual Atmos Health 2014; 7:433-439

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Panayiotis Yiallouros, Professor, University of Cyprus
ClinicalTrials.gov Identifier: NCT03503812    
Other Study ID Numbers: LIFE MEDEA Protocol
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Panayiotis Yiallouros, University of Cyprus:
Randomized clinical trial
Public Health Intervention
Behavioral Intervention
Exposure-Reduction Approaches
Desert dust storm events
Climate change
Asthma in children
Atrial Fibrillation
Air pollution
Additional relevant MeSH terms:
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Asthma
Atrial Fibrillation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes