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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 6
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Study design for the panel study with asthmatic children:
Children with asthma will be recruited during DDS outbreaks and will be randomized into three parallel groups to receive:
- No intervention for DDS,
- Intervention for outdoor exposure reduction, and
- Interventions for both outdoor and indoor exposure reduction.
Disease-related adverse health outcomes will be assessed in all the parallel arms of the study.
Previous publications of the MEDEA investigators, indicated that 2/3 of each year's DDS events in the Eastern Mediterranean region appear during February-May, with 10-15% of the days during this period being "DDS days". Thus, the investigators will perform this panel study during February-May of 2019, and 2021. In addition, the panel study will run in September - December (a period also characterized with frequent DDS events) of the same years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
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
时间窗: 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
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
时间窗: 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
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.
时间窗: 6 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.
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.
时间窗: 6 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.
次要结局
- Comparison of air pollution exposure between the no intervention group and the two intervention groups in adults with AF during the high DDS periods(6 months)
- 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 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 unscheduled hospital visits between the no intervention group and the two intervention groups in adults with AF during the high DDS periods(6 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 air pollution exposure between the no intervention group and the two intervention groups in children with Asthma during the high DDS periods(4 months)
- Comparison of health related quality of life between the no intervention group and the two intervention groups in adults with AF during the high DDS periods(6 months)
- Comparison of arrhythmia medication use between the no intervention group and the two intervention groups in adults with AF during the high DDS periods(6 months)
研究者
Panayiotis Yiallouros
Professor
University of Cyprus