Clinical trial NCT05639101: GeoAsma: Pilot and Evaluation of a Clinical Decision Support System and a Mobile App for the Management of Asthma Patients.
Official title: GeoAsma: Pilot and Evaluation of a Clinical Decision Support System and a Mobile App for the Management of Asthma Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 214
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma control
timeFrame: 1 year
measure: Number of exacerbations Number of exacerbations
timeFrame: 1 year
measure: Health-related quality of life
timeFrame: 1 year
measure: Quality-adjusted life year
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
measure: Respiratory function
timeFrame: 1 year
measure: Immune response
timeFrame: 1 year
measure: Treatment adherence
timeFrame: 1 year
Secondary outcomes:
measure: Economic evaluation
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: