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

NCT03503812 | Completed

• 1 other identifier: LIFE MEDEA Protocol
• Study Type: interventional
• Target: 310
• Locations: 3 countries
• Sites: 3

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.

Conditions

Asthma in Children; Atrial Fibrillation

Keywords

Randomized clinical trial; Public Health Intervention; Behavioral Intervention; Exposure-Reduction Approaches; Desert dust storm events; Climate change; Asthma in children; Atrial Fibrillation; Air pollution

Outcome Measures

Primary Outcomes (4)

• 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

  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

  4 months

• 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

  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

  4 months

• 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.

  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.

  6 months

• 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.

  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.

  6 months

Secondary Outcomes (9)

• Comparison of the secondary outcome measures between the no intervention group and the 2 intervention groups during the high DDS period of 2019

  4 months

• Comparison of the secondary outcome measures between the no intervention group and the 2 intervention groups during the high DDS period of 2020

  4 months

• 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.

  6 months

• 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.

  6 months

• Comparison of air pollution exposure between the no intervention group and the two intervention groups in children with Asthma during the high DDS periods

  4 months

Study Arms (6)

No intervention to DDS exposure - Asthma in Children

NO INTERVENTION

Intervention 1 - Asthma in Children

EXPERIMENTAL

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

Intervention 2 - Asthma in Children

EXPERIMENTAL

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

No intervention to DDS exposure - Atrial Fibrillation

NO INTERVENTION

Intervention 1 - Atrial Fibrillation

EXPERIMENTAL

Behavioral: Intervention (1) for outdoor exposure reduction - Atrial Fibrillation

Intervention 2 - Atrial Fibrillation

EXPERIMENTAL

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

Interventions

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

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

Intervention 1 - Asthma in Children

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

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.

Intervention 2 - Asthma in Children

Intervention (1) for outdoor exposure reduction - Atrial Fibrillation BEHAVIORAL

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

Intervention 1 - Atrial Fibrillation

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

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.

Intervention 2 - Atrial Fibrillation

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Lung disease other than asthma
• Cardiovascular disease
• Not living at least 5 days per week in the household
• A history of AF or
• Detection of AF in pacemaker/ICD monitoring
• 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.

Sponsors & Collaborators

• University of Cyprus: lead
• University of Crete: collaborator
• Soroka University Medical Center: collaborator
• Cyprus University of Technology: collaborator
• Department of Labor Inspection, Ministry of Labor, Welfare and Social Insurance, Cyprus: collaborator
• Department of Meteorology, Ministry of Agriculture, Rural Development and Environment, Cyprus: collaborator
• Cyprus Broadcasting Corporation: collaborator
• E.n.A Consulting LP: collaborator

Study Sites (3)

Medical School, University of Cyprus

Nicosia, Aglantzia, 2029, Cyprus

Location

School of Medicine, University of Crete

Heraklion, Crete, GR-71003, Greece

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Related Publications (14)

• Achilleos S, Evans JS, Yiallouros PK, Kleanthous S, Schwartz J, Koutrakis P. PM10 concentration levels at an urban and background site in Cyprus: the impact of urban sources and dust storms. J Air Waste Manag Assoc. 2014 Dec;64(12):1352-60. doi: 10.1080/10962247.2014.923061.

  PMID: 25562931 BACKGROUND

• Gerasopoulos E, et al. Origin and variability of particulate matter (PM10) mass concentrations over the Eastern Mediterranean. Atmos Environ 2006; 40:4679-4690.

  BACKGROUND

• Griffin DW. Atmospheric movement of microorganisms in clouds of desert dust and implications for human health. Clin Microbiol Rev. 2007 Jul;20(3):459-77, table of contents. doi: 10.1128/CMR.00039-06.

  PMID: 17630335 BACKGROUND

• Krasnov H, Katra I, Koutrakis P, Friger MD. Contribution of dust storms to PM10 levels in an urban arid environment. J Air Waste Manag Assoc. 2014 Jan;64(1):89-94. doi: 10.1080/10962247.2013.841599.

  PMID: 24620406 BACKGROUND

• Leski TA, Malanoski AP, Gregory MJ, Lin B, Stenger DA. Application of a broad-range resequencing array for detection of pathogens in desert dust samples from Kuwait and Iraq. Appl Environ Microbiol. 2011 Jul;77(13):4285-92. doi: 10.1128/AEM.00021-11. Epub 2011 May 13.

  PMID: 21571877 BACKGROUND

• Mallone S, Stafoggia M, Faustini A, Gobbi GP, Marconi A, Forastiere F. Saharan dust and associations between particulate matter and daily mortality in Rome, Italy. Environ Health Perspect. 2011 Oct;119(10):1409-14. doi: 10.1289/ehp.1003026.

  PMID: 21970945 BACKGROUND

• Middleton N, Yiallouros P, Kleanthous S, Kolokotroni O, Schwartz J, Dockery DW, Demokritou P, Koutrakis P. A 10-year time-series analysis of respiratory and cardiovascular morbidity in Nicosia, Cyprus: the effect of short-term changes in air pollution and dust storms. Environ Health. 2008 Jul 22;7:39. doi: 10.1186/1476-069X-7-39.

  PMID: 18647382 BACKGROUND

• Neophytou AM, Yiallouros P, Coull BA, Kleanthous S, Pavlou P, Pashiardis S, Dockery DW, Koutrakis P, Laden F. Particulate matter concentrations during desert dust outbreaks and daily mortality in Nicosia, Cyprus. J Expo Sci Environ Epidemiol. 2013 May-Jun;23(3):275-80. doi: 10.1038/jes.2013.10. Epub 2013 Feb 20.

  PMID: 23423218 BACKGROUND

• Querol X, et al. African dust contributions to mean ambient PM10 mass-levels across the Mediterranean, Basin. Atmos Environ 2009; 43:4266-4277

  BACKGROUND

• Samoli E, Nastos PT, Paliatsos AG, Katsouyanni K, Priftis KN. Acute effects of air pollution on pediatric asthma exacerbation: evidence of association and effect modification. Environ Res. 2011 Apr;111(3):418-24. doi: 10.1016/j.envres.2011.01.014.

  PMID: 21296347 BACKGROUND

• 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

  BACKGROUND

• Kouis P, Galanakis E, Michaelidou E, Kinni P, Michanikou A, Pitsios C, Perez J, Achilleos S, Middleton N, Anagnostopoulou P, Dimitriou H, Revvas E, Stamatelatos G, Zacharatos H, Savvides C, Vasiliadou E, Kalivitis N, Chrysanthou A, Tymvios F, Papatheodorou SI, Koutrakis P, Yiallouros PK. Improved childhood asthma control after exposure reduction interventions for desert dust and anthropogenic air pollution: the MEDEA randomised controlled trial. Thorax. 2024 May 20;79(6):495-507. doi: 10.1136/thorax-2023-220877.

  PMID: 38388489 DERIVED

• Anagnostopoulou P, Kouis P, Papatheodorou SI, Middleton N, Papasavvas I, Avraamides P, Simantirakis E, Anastasiou I, Novack V, Stamatelatos G, Revvas E, Kaniklides C, Tymvios F, Savvides C, Koutrakis P, Yiallouros PK. MEDEA randomised intervention study protocol in Cyprus, Greece and Israel for mitigation of desert dust health effects in adults with atrial fibrillation. BMJ Open. 2023 Mar 24;13(3):e069809. doi: 10.1136/bmjopen-2022-069809.

  PMID: 36963790 DERIVED

• Kouis P, Papatheodorou SI, Kakkoura MG, Middleton N, Galanakis E, Michaelidi E, Achilleos S, Mihalopoulos N, Neophytou M, Stamatelatos G, Kaniklides C, Revvas E, Tymvios F, Savvides C, Koutrakis P, Yiallouros PK. The MEDEA childhood asthma study design for mitigation of desert dust health effects: implementation of novel methods for assessment of air pollution exposure and lessons learned. BMC Pediatr. 2021 Jan 6;21(1):13. doi: 10.1186/s12887-020-02472-4.

  PMID: 33407248 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Methods

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Panayiotis Yiallouros, MD, PhD

  Medical School, University of Cyprus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 20, 2018
• Study Start: September 24, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

GR (1); CY (1); IL (1)