Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05637411 |
| Other study ID # |
PI19/01092 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 9, 2020 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
November 2022 |
| Source |
Hospital Universitario Virgen Macarena |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
