AsthmaGeoAsmaNCT05639101
GeoAsma: Pilot and Evaluation of a Clinical Decision Support System and a Mobile App for the Management of Asthma Patients.
A study testing Clinical Decission support system management & mobile App Intervention Group in people with Asthma, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
GeoAsma is a study for the definition, validation and evaluation of predictive models on the influence of the environment on asthmatic patients in Andalusia. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Clinical Decission support system management & mobile App Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSpain
- Study dates
- 24 Jul 2020to 31 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosed with bronchial asthma in its intermittent and persistent degrees mild/moderate.
- No respiratory infections in the month prior to testing.
- Availability and/or ability to use a Smartphone.
Who cannot join
- Severe persistent asthmatics.
- Pregnant women, breastfeeding women or women who 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.
- Treatment with systemic corticosteroids during the 6 months prior to or during the study.
- Subjects with problems that limit their ability to cooperate.
- Subjects unable to perform correct spirometric maneuvers.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Alberto Moreno Conde
Seville, 41018
Alberto Moreno Conde, innovacion.hvm.sspa@juntadeandalucia.es
About this study
GeoAsma is a study for the definition, validation and evaluation of predictive models on the influence of the environment on asthmatic patients in Andalusia.
Read the detailed description
Although for decades there have been multiple studies on the association of asthma with factors such as weather conditions, pollution, pollen and the social condition of patients, the GeoAsma project aims to advance the study of environmental factors that influence the health of asthmatic patients by combining BigData technology and data mining analysis, Geographic Information Systems and open data provided by official sources with data from the Electronic Health Record of the Andalusian Health System, that provides healthcare services to more than 8,000,000 citizens.
This project aims to study through data mining techniques and multilevel analysis the influence of clinical and environmental factors: pollen level, air pollution, atmospheric conditions and social determinants in more than 800,000 asthmatic patients during the last 15 years in Andalusia, the southernmost region of Spain. It is expected that the results of this study will serve to define predictive models that will help professionals and patients in our region to make decisions.
After the validation of the models, a decision support system will be implemented in a web platform and in a mobile application. Its impact on the reduction of exacerbations, control, quality of life and resource consumption of asthmatic patients will be analysed. This evaluation will be carried out through a pilot with 214 patients with a follow-up period of 12 months with asthma in the hospitals participating in this proposal.
- Conditions
- Asthma
- Being tested
- Clinical Decission support system management & mobile App Intervention Group
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decission support system management & mobile App Intervention GroupOther
The clinicians treating the patients will use a clinical decision support system that includes predictive models associated with the level of risk of exacerbation. This models have been obtained in asthmatic patients by applying data mining techniques and multilevel analysis in the study of the influence of clinical characteristics and the environment of each subject.
The patients will use a mobile app to help manage their symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Clinicians will use a Clinical decision support system to better manage their patients. Asthmatic patients will use a smartphone app for their self management. Receives: Other: Clinical Decission support system management & mobile App Intervention Group |
| Control | No intervention | Asthmatic patients that will not be subject to any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
The Asthma Control Test is a validated determination of asthma control that is directly control of asthma that is answered directly by the patient and consists of five questions questions that assess: activity limitations, dyspnea, nocturnal symptoms, rescue medication use, and the patient's overall rating of asthma control. symptoms, use of rescue medication, and the patient's overall rating of asthma control over the previous four weeks, which is defined from the results of a questionnaire.
Measured: 1 year
Number of exacerbations Number of 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
Health-related quality of life
The Asthma Quality of Life Questionnaire (AQLQ) will be administered at baseline, 3 and 6 months of the study. The AQLQ contains 32 items corresponding to 4 dimensions of health: limitation of usual activities, symptoms, emotional function, and environmental stimuli.
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
Patient satisfaction
It will be carried out at the end of the study by means of a questionnaire that includes items on ease of use, usefulness, intention to use, etc.
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
Secondary outcomes (1)
Economic evaluation
Incremental cost-efectiveness ratio and incremental cost-utility ratio between the intervention group and control group
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 posted6 Dec 2022
- Study start24 Jul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Decision support system for professionals and mobile app for self-management in patients based on the analysis of the influence of clinical and environmental characteristics on the population of asthmatic patients in our region.
- Masking
- None (open label)
- 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
- NCT05639101
- Sponsor's protocol ID
- PI-0100-2020
- Acronym
- GeoAsma
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2022
- Last updated
- 6 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GeoAsma: Pilot and Evaluation of a Clinical Decision Support System and a Mobile App for the Management of Asthma Patients.
- ClinicalTrials.gov ID
- NCT05639101
- Acronym / sponsor ID
- GeoAsma / PI-0100-2020
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 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.
GeoAsma is a study for the definition, validation and evaluation of predictive models on the influence of the environment on asthmatic patients in Andalusia.
Detailed description
Although for decades there have been multiple studies on the association of asthma with factors such as weather conditions, pollution, pollen and the social condition of patients, the GeoAsma project aims to advance the study of environmental factors that influence the health of asthmatic patients by combining BigData technology and data mining analysis, Geographic Information Systems and open data provided by official sources with data from the Electronic Health Record of the Andalusian Health System, that provides healthcare services to more than 8,000,000 citizens.
This project aims to study through data mining techniques and multilevel analysis the influence of clinical and environmental factors: pollen level, air pollution, atmospheric conditions and social determinants in more than 800,000 asthmatic patients during the last 15 years in Andalusia, the southernmost region of Spain. It is expected that the results of this study will serve to define predictive models that will help professionals and patients in our region to make decisions.
After the validation of the models, a decision support system will be implemented in a web platform and in a mobile application. Its impact on the reduction of exacerbations, control, quality of life and resource consumption of asthmatic patients will be analysed. This evaluation will be carried out through a pilot with 214 patients with a follow-up period of 12 months with asthma in the hospitals participating in this proposal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Decision support system for professionals and mobile app for self-management in patients based on the analysis of the influence of clinical and environmental characteristics on the population of asthmatic patients in our region.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Clinical Decission support system management & mobile App Intervention GroupClinicians will use a Clinical decision support system to better manage their patients. Asthmatic patients will use a smartphone app for their self management. |
| Control | No intervention | –Asthmatic patients that will not be subject to any intervention |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with bronchial asthma in its intermittent and persistent degrees mild/moderate.
- No respiratory infections in the month prior to testing.
- Availability and/or ability to use a Smartphone.
Key exclusion criteria (6 listed)
- Severe persistent asthmatics.
- Pregnant women, breastfeeding women or women who 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.
- Treatment with systemic corticosteroids during the 6 months prior to or during 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 |
|---|---|---|
| Clinical Decission support system management & mobile App Intervention GroupThe clinicians treating the patients will use a clinical decision support system that includes predictive models associated with the level of risk of exacerbation. This models have been obtained in asthmatic patients by applying data mining techniques and multilevel analysis in the study of the influence of clinical characteristics and the environment of each subject. The patients will use a mobile app to help manage their symptoms. | Other | Intervention group |
Primary outcome
Asthma control
Time frame: 1 year
The Asthma Control Test is a validated determination of asthma control that is directly control of asthma that is answered directly by the patient and consists of five questions questions that assess: activity limitations, dyspnea, nocturnal symptoms, rescue medication use, and the patient's overall rating of asthma control. symptoms, use of rescue medication, and the patient's overall rating of asthma control over the previous four weeks, which is defined from the results of a questionnaire.
Number of exacerbations Number of 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.
Health-related quality of life
Time frame: 1 year
The Asthma Quality of Life Questionnaire (AQLQ) will be administered at baseline, 3 and 6 months of the study. The AQLQ contains 32 items corresponding to 4 dimensions of health: limitation of usual activities, symptoms, emotional function, and environmental stimuli.
Quality-adjusted life year
Time frame: 1 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).
Patient satisfaction
Time frame: 1 year
It will be carried out at the end of the study by means of a questionnaire that includes items on ease of use, usefulness, intention to use, etc.
Respiratory function
Time frame: 1 year
Several pulmonary function tests will be carried out. These tests will include spirometry (FEV1, FVC, FEV1/FVC ratio, PC20, PD15, Fractional exhaled nitric oxide)
Immune response
Time frame: 1 year
IgE test, lymphocite count
Treatment adherence
Time frame: 1 year
Estimated through dispensations
1 secondary outcome
Economic evaluation
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 6 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?
A study testing Clinical Decission support system management & mobile App Intervention Group in people with Asthma, 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 3 inclusion and 6 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 6 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?
Contact Alberto Moreno (647777159 ext. +34, innovacion.hvm.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control (time frame: 1 year). The study lists 8 primary outcomes in all. 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 6 Dec 2022.