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

Asthma Clinical Trial

— GeoAsma  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639101
• Other study ID #: PI-0100-2020
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Hospital Universitario Virgen Macarena
• Contact: Alberto Moreno
• Phone: 647777159
• Email: innovacion.hvm.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Alberto Moreno Conde	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen Macarena

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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).	1 year
Primary	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.	1 year
Primary	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)	1 year
Primary	Immune response	IgE test, lymphocite count	1 year
Primary	Treatment adherence	Estimated through dispensations	1 year
Secondary	Economic evaluation	Incremental cost-efectiveness ratio and incremental cost-utility ratio between the intervention group and control group	1 year