AsthmaNCT05637411
GeoHealth: Geographic Information System for Health Management and Clinical, Epidemiological and Translational Research
An observational study of Asthma and Allergy, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma, Allergy, Heart Diseases
- What is being tested?
- Predictive model
- How many people
- 214 participants
- Where
- 1 siteSpain
- Study dates
- 9 Dec 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Our population is composed of patients with bornchial asthma.
Who may be able to join
- Patients diagnosed with bornchial asthma.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma, Allergy, Heart Diseases, Obesity, Rheumatic Diseases
- Being tested
- Predictive model
- Medical subject headings
- Asthma, Hypersensitivity, Heart Diseases, Obesity, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictive modelOther
We will define and validate predictive models of risk of exacerbations in asthmatic patients
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | The clinical data, socioeconomical data and environmental exposure data from 800.000 asthmatic patients attended in our region from 2007 to 2021 will be analysed to train and validate a risk predictive model for exacerbation (defined as emergency visits) Receives: Other: Predictive model | |
| Prospective cohort | The same inclusion/exclusion criteria were applied prospectively. This is an external validation cohort. Receives: Other: Predictive model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbations
Measured by the number of times the patient goes to the emergency room or uses rescue medication and/or cycles of oral corticosteroids.
Measured: 1 year
Secondary outcomes (5)
Asthma control
Asthma control, obtained through the Asthma Control Test.
Measured: 1 year
Quality-adjusted life year
To calculate this index, the EuroQol-5D quality of life questionnaire will be administered at baseline, three and six months into the study. The EQ-5D describes health status with five dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression), each of which is defined with three levels of severity. It also consists of a millimetered Visual Analog Scale (VAS) on which the subject must score his or her health status on the day of the survey, with the extremes of the scale being the worst imaginable health status (0) and the best imaginable health status (100).
Measured: 1 year
Respiratory function
Several pulmonary function tests will be carried out. These tests will include spirometry (FEV1, FVC, FEV1/FVC ratio, PC20, PD15, Fractional exhaled nitric oxide)
Measured: 1 year
Immune response
IgE test, lymphocite count
Measured: 1 year
Treatment adherence
estimated through dispensations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start9 Dec 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Moreno Conde, Hospital Universitario Virgen Macarena
- Investigators
- Alberto Moreno, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637411
- Sponsor's protocol ID
- PI19/01092
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GeoHealth: Geographic Information System for Health Management and Clinical, Epidemiological and Translational Research
- ClinicalTrials.gov ID
- NCT05637411
- Acronym / sponsor ID
- PI19/01092
- Conditions
- Asthma, Allergy, Heart Diseases, Obesity, Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: Predictive modelThe clinical data, socioeconomical data and environmental exposure data from 800.000 asthmatic patients attended in our region from 2007 to 2021 will be analysed to train and validate a risk predictive model for exacerbation (defined as emergency visits) |
| Prospective cohort | – | Other: Predictive modelThe same inclusion/exclusion criteria were applied prospectively. This is an external validation cohort. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our population is composed of patients with bornchial asthma.
Key inclusion criteria (1 listed)
- Patients diagnosed with bornchial asthma.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predictive modelWe will define and validate predictive models of risk of exacerbations in asthmatic patients | Other | Prospective cohort, Retrospective cohort |
Primary outcome
Exacerbations
Time frame: 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.
5 secondary outcomes
Asthma control
Time frame: 1 year
Quality-adjusted life year
Time frame: 1 year
Respiratory function
Time frame: 1 year
Immune response
Time frame: 1 year
Treatment adherence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Moreno principal investigator
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergy, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.