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

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

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Clinical Decission support system management & mobile App Intervention Group

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 Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto Moreno; Phone Number: +34 647777159; Email: innovacion.hvm.sspa@juntadeandalucia.es
• Study Contact Backup: Name: Pedro Guardia; Phone Number: +34 955057648; Email: pedro.guardia.sspa@juntadeandalucia.es

Study Locations

• Spain
  • Sevilla, Spain, 41018
    • Recruiting
    • Alberto Moreno Conde
    • Contact: Alberto Moreno Conde; Email: innovacion.hvm.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
No Intervention: Control; Asthmatic patients that will not be subject to any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Immune response	IgE test, lymphocite count	1 year
Treatment adherence	Estimated through dispensations	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic evaluation	Incremental cost-efectiveness ratio and incremental cost-utility ratio between the intervention group and control group	1 year

Collaborators and Investigators

• Sponsor: Hospital Universitario Virgen Macarena
• Investigators: Principal Investigator: Alberto Moreno, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: PI-0100-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No