GeoHealth: Geographic Information System for Health Management and Clinical, Epidemiological and Translational Research
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Exacerbations
研究概览
简要总结
The objective of the project is to develop a potentially marketable system for clinical, epidemiological and translational research capable of associating contextual variables and geospatial data with clinical patient information. The GeoHealth system will include a section to perform exploratory analysis that will help identify risk factors to optimize clinical decision making. The system will be used in a study of the influence of environmental factors in more than 800,000 asthmatic patients in the region of Andalucía, Spain. The results of this study will help to develop predictive models of risk of exacerbation in asthma patients. Currently, disease management guidelines state that asthma control has two components: current disease control and future risk of exacerbations. These two components are key when assessing disease management, following a stepwise model that seeks to improve current control and minimize future risk. However, although the current control of the disease is defined and has established methodologies for its measurement (Asthma Control Test -ACT- and Asthma Control Questionnaire -ACQ-), the risk of suffering exacerbations is not yet a measurable component.
Therefore, these predictive models could help in professional decision making for asthmatic patients.
The predictive models will be validated prospectively and implemented in a decision support system for the management of asthmatic patients.
详细描述
The GeoHealth system will be designed as a modular platform that will allow communication to import patient data from EHR systems and research platforms through the ISO13606 and CDISC ODM standards. Furthermore, integrations will be made with the Andalusian HCE (Diraya) systems and the REDCap and OpenClinica clinical trial management systems.
GeoHealth integrates a set of heterogeneous open data sources, allowing a visualization, on the same map, of the clinical and contextual data of each patient based on their usual location (Census region of their home) and the desired date of the study. The data integrated into the system provide demographic information and the environmental conditions associated with the location of the patient.
The system has a module that perform analysis that can range from simple correlations between variables to other more complex analyzes such as clustering analysis, linear and logistic regressions and others.
Once the models that will be applied in decision-making have been determined, a study will be carried out on the degree of alignment between the recommendations established by the models and the clinical decision adopted by the professionals. The study will be performed during a period of 12 months in patients treated in the clinical centers that participate in this project.
The data come from different sources and all have been integrated into the same representation system. Using the free mapping system "OpenStreetMap" and the "Plotly" Python library, both the demographic data of the patients and their contextual variables are represented in a Dashboard, containing a single map.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients diagnosed with bornchial asthma.
排除标准
- •Women who are pregnant, breastfeeding or want to become pregnant during the duration of the study.
- •Subjects with malignant disease, uncontrolled risk factors or any pathology that compromises the safety of the study.
- •Subjects with problems that limit their ability to cooperate.
结局指标
主要结局
Exacerbations
时间窗: 1 year
Measured by the number of times the patient goes to the emergency room or uses rescue medication and/or cycles of oral corticosteroids.
次要结局
- Treatment adherence(1 year)
- Asthma control(1 year)
- Quality-adjusted life year(1 year)
- Respiratory function(1 year)
- Immune response(1 year)
研究者
Alberto Moreno Conde
PHD Alberto Moreno Conde
Hospital Universitario Virgen Macarena