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

NCT ID: NCT05639101

Last Updated: 2022-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-24

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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

Group Type OTHER

Clinical Decission support system management & mobile App Intervention Group

Intervention Type OTHER

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.

Control

Asthmatic patients that will not be subject to any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clinical Decission support system management & mobile App Intervention Group

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alberto Moreno Conde

PHD Alberto Moreno Conde

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alberto Moreno

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alberto Moreno Conde

Seville, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alberto Moreno

Role: CONTACT

647777159 ext. +34

Pedro Guardia

Role: CONTACT

955057648 ext. +34

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alberto Moreno Conde

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI-0100-2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Asthma Research in Children and Adolescents
NCT04480242 ACTIVE_NOT_RECRUITING