Clinical trial NCT05637411: GeoHealth: Geographic Information System for Health Management and Clinical, Epidemiological and Translational Research
Official title: GeoHealth: Geographic Information System for Health Management and Clinical, Epidemiological and Translational Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Allergy
Heart Diseases
Obesity
Rheumatic Diseases
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 214
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our population is composed of patients with bornchial asthma.

Brief summary: 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.

Detailed description: 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.

The system offers the possibility to deploy different heat-maps using different regions (Census Regions, Postal Code Regions and Health Districts) and different demographic variables for each type of region (Population density, percentage of males and females, average incomes...etc.). Moreover, it is possible to choose between the different regions of Andalucía and a range of dates for the environmental (Pollution, pollen and meteorological data) and patient's data. Other places locations are deployed on the map as hospitals, clinics, roads and parks.

The system provides an advance in the deployment, observation and analysis for the health sector. It allows clinical researchers to understand better how the patient is affected by his environment and perform analysis to discover patterns in the data.

Other systems such as Transmart or i2b2, enable sharing, integration, standardization, and analysis of heterogeneous data from healthcare and translational research. GeoHealth has been presented as a possible extension of these two platforms helping them to incorporate the possibility to include geospatial data in the analysis.

Moreover, the system is going to be used and tested in two projects than aim to analyze the prevalence of asthmatic patients in the Macarena Hospital's area (Sevilla, Spain) and another in the region of Andalucía (Spain) where more than 800.000 patients will be analyzed.

It has been demonstrated how decisive the patient's environment is in the development of many diseases. GeoHealth has been presented as a platform that allows clinical researchers in the observation and analysis task to understand better how the environment affect them.

Moreover, the performed extraction, processing and integration of the open-data in the system and the intuitive deployment on a single map allow researchers to save time and access advanced analysis techniques that can be performed without the knowledge necessary to develop the algorithms that form them.

All these aspects make GeoHealth an innovative platform with a potential impact on the development of clinical studies related to the location and environment of the patients.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with bornchial asthma.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Exacerbations
timeFrame: 1 year
Secondary outcomes:
measure: Asthma control
timeFrame: 1 year
measure: Quality-adjusted life year
timeFrame: 1 year
measure: Respiratory function
timeFrame: 1 year
measure: Immune response
timeFrame: 1 year
measure: Treatment adherence
timeFrame: 1 year
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Alberto Moreno Conde
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Alberto Moreno
role: PRINCIPAL_INVESTIGATOR
References: