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

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Clinical Decission support system management & mobile App Intervention Group
Sponsored by
Hospital Universitario Virgen Macarena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alberto Moreno CondeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention group

Control

Arm Description

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

Asthmatic patients that will not be subject to any intervention

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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.
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)
Immune response
IgE test, lymphocite count
Treatment adherence
Estimated through dispensations

Secondary Outcome Measures

Economic evaluation
Incremental cost-efectiveness ratio and incremental cost-utility ratio between the intervention group and control group

Full Information

First Posted
August 1, 2022
Last Updated
November 24, 2022
Sponsor
Hospital Universitario Virgen Macarena
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1. Study Identification

Unique Protocol Identification Number
NCT05639101
Brief Title
GeoAsma: Pilot and Evaluation of a Clinical Decision Support System and a Mobile App for the Management of Asthma Patients.
Acronym
GeoAsma
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen Macarena

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Other
Arm Description
Clinicians will use a Clinical decision support system to better manage their patients. Asthmatic patients will use a smartphone app for their self management.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Asthmatic patients that will not be subject to any intervention
Intervention Type
Other
Intervention Name(s)
Clinical Decission support system management & mobile App Intervention Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma control
Description
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.
Time Frame
1 year
Title
Number of exacerbations Number of exacerbations
Description
Measured by the number of times the patient goes to the emergency room or uses rescue medication and/or cycles of oral corticosteroids.
Time Frame
1 year
Title
Health-related quality of life
Description
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.
Time Frame
1 year
Title
Quality-adjusted life year
Description
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).
Time Frame
1 year
Title
Patient satisfaction
Description
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.
Time Frame
1 year
Title
Respiratory function
Description
Several pulmonary function tests will be carried out. These tests will include spirometry (FEV1, FVC, FEV1/FVC ratio, PC20, PD15, Fractional exhaled nitric oxide)
Time Frame
1 year
Title
Immune response
Description
IgE test, lymphocite count
Time Frame
1 year
Title
Treatment adherence
Description
Estimated through dispensations
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Economic evaluation
Description
Incremental cost-efectiveness ratio and incremental cost-utility ratio between the intervention group and control group
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Moreno
Phone
647777159
Ext
+34
Email
innovacion.hvm.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Guardia
Phone
955057648
Ext
+34
Email
pedro.guardia.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Moreno
Organizational Affiliation
Hospital Universitario Virgen Macarena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberto Moreno Conde
City
Sevilla
ZIP/Postal Code
41018
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Moreno Conde
Email
innovacion.hvm.sspa@juntadeandalucia.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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