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

NCT05639101 | Unknown

• 1 other identifier: PI-0100-2020
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Economic evaluation

  1 year

Study Arms (2)

Intervention group

OTHER

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

Control

NO INTERVENTION

Asthmatic patients that will not be subject to any intervention

Interventions

Clinical Decission support system management & mobile App Intervention Group 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.

Intervention group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead

Study Sites (1)

Alberto Moreno Conde

Seville, 41018, Spain

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alberto Moreno

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Moreno

CONTACT

647777159; innovacion.hvm.sspa@juntadeandalucia.es

Pedro Guardia

CONTACT

955057648; pedro.guardia.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Alberto Moreno Conde

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: December 6, 2022
• Study Start: July 24, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)