GeoAsma: Pilot and Evaluation of a Clinical Decision Support System and a Mobile App for the Management of Asthma Patients.

Andalusian Health Service

Status: Enrolling

Conditions: Asthma

Treatments: Other: Clinical Decission support system management & mobile App Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05639101

PI-0100-2020

Details and patient eligibility

About

GeoAsma is a study for the definition, validation and evaluation of predictive models on the influence of the environment on asthmatic patients in Andalusia.

Full 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.

Enrollment: 214 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Intervention group

Other group

Description:

Clinicians will use a Clinical decision support system to better manage their patients. Asthmatic patients will use a smartphone app for their self management.

Treatment:

Other: Clinical Decission support system management & mobile App Intervention Group

Control

No Intervention group

Description:

Asthmatic patients that will not be subject to any intervention