Impact of the Implementation of a Telemedicine Program on Patients Diagnosed with Asthma
NCT ID: NCT06116292
Last Updated: 2024-10-22
Study Results
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Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2024-01-01
2026-12-31
Brief Summary
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Objective: To assess the impact of implementing a mobile application (ESTOI) in patients diagnosed with asthma on disease control, treatment adherence, and perceived quality of life.
Methodology: A 52-week randomized clinical trial involving asthma patients receiving care at a highly specialized hospital in Spain. A total of 108 patients will be included and divided into two groups. The intervention group will receive more comprehensive monitoring than usual, including access to the ESTOI application. The Asthma Control Test (ACT) questionnaire will be used as the primary assessment variable. Other variables to be studied include the Inhaler Adherence Test (TAI), the number of exacerbations, peak expiratory flow, exhaled nitric oxide examination, hospital anxiety and depression scale, asthma quality of life questionnaire, forced spirometry parameters (FVC, FEV1, and reversibility), and analytical parameters (eosinophilia and IgE).
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Detailed Description
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Setting and Subjects: The study will take place in the pulmonology department of Bellvitge University Hospital in Barcelona, during the years 2024-2026.
Procedure and Instruments: The project will be structured into three visits. During the first visit, all participants will be seen by the pulmonologist at our center for asthma classification, inhaler updates, and requests for additional tests. Subsequently, the control group will receive health education (provided by the asthma specialist nurse) regarding their condition, treatment plan, signs of alarm, action plan, and a review of asthma triggers. On the other hand, intervention group patients, in addition to health education, will be introduced to the ESTOI application database and provided access to the patient portal, where patients will find all the necessary information on asthma management. Both groups will receive a Peakflow meter and instructions on its use and record-keeping.
A nurse will be responsible for managing and monitoring the patients using the application. Patients will also schedule and review the medical records of all patients included in the study and review the data collection notebooks and informed consents. The asthma specialist nurse will be responsible for conducting the questionnaires, collecting data for the Case Report Form (CRF), performing laboratory tests, and conducting respiratory functional tests.
During the three study visits, all included patients will complete the study questionnaires: Asthma Control Test (ACT), Inhaler Adherence Test (TAI), Asthma Quality of Life Questionnaire (AQLQ), and the Hospital Anxiety and Depression Scale (HAD). Afterward, the electronic history of medication dispenses will be reviewed, exhaled nitric oxide (FeNO) will be measured, a spirometry test with bronchodilator response, a control blood test, and an on-site measurement of Peak Expiratory Flow (PEF) using the Peakflow meter will be conducted.
At the end of the first visit, all participants will be scheduled for the next visit and provided with a contact phone number in case the patients have any questions or issues.
Upon completion of the third visit, the intervention group will be given a satisfaction questionnaire for having used the application."
All relevant study data will be recorded in each patient's data collection notebook for subsequent analysis. These notebooks will be stored at the center in a locked room accessible only to the research team. Sociodemographic variables will be collected by the asthma unit nurse during the first study visit.
Information about the current state of asthma will be obtained through questionnaires, respiratory functional tests, laboratory tests, and a review of the patient's medical history.
Data Analysis: Continuous variables will be expressed as mean and standard deviation in case of a normal distribution, and as median and interquartile range in case of a non-normal distribution. Qualitative variables will be presented as frequencies and percentages. For the comparison of continuous variables, analysis of variance (ANOVA) or the Kruskal-Wallis test will be used. The chi-square test will be performed for the analysis of the primary outcome variable. Stepwise logistic regression models will be used to select the subgroup of parameters significantly associated with poor asthma control. A priori, the factors included in the analysis will be age, asthma duration, education level, BMI, smoking, environmental exposure, pre-BD FEV1, post-BD FEV1, FeNO, blood eosinophilia, general and specific blood IgE levels, ACT, TAI, HAD, AQLQ, the number of exacerbations, and control of comorbidities affecting asthma (GERD, rhinitis, polyps, overweight/obesity, and smoking). Statistical significance will be assumed at p \< 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mobile application ESTOI for Asthmatic patients
The intervention group will receive the usual care, in addition to having access to the ESTOI application.
The mobile application ESTOI for Asthmatic patients
The mobile application ESTOI have various sections that can be managed and customized by the researchers to meet each patient's needs:
1. SYMPTOM CONTROL, it will record the ACT, TAI, the number of exacerbations, weight, and, depending on the case, symptom control for comorbidities.
2. RECOMMENDATIONS, it will provide patients with information needed to understand their condition, how to control it, and what to do in case of worsening symptoms.
3. YOUR TREATMENT, it will display personalized and update information about the patient's current asthma medication, including dosages and frequencies. There will be explanatory videos on how to administer the therapy and includes an action plan.
4. PEAK FLOW, the patient can record measurements using a Peak Flow Meter at home.
5. NUTRITIONAL PLAN, it will provide a daily dietary guide to enable individuals to adapt these tools and recommendations to their specific needs.
6. MESSAGING, it is a bidirectional contact area.
Standard of care
The intervention group will receive the usual care
No interventions assigned to this group
Interventions
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The mobile application ESTOI for Asthmatic patients
The mobile application ESTOI have various sections that can be managed and customized by the researchers to meet each patient's needs:
1. SYMPTOM CONTROL, it will record the ACT, TAI, the number of exacerbations, weight, and, depending on the case, symptom control for comorbidities.
2. RECOMMENDATIONS, it will provide patients with information needed to understand their condition, how to control it, and what to do in case of worsening symptoms.
3. YOUR TREATMENT, it will display personalized and update information about the patient's current asthma medication, including dosages and frequencies. There will be explanatory videos on how to administer the therapy and includes an action plan.
4. PEAK FLOW, the patient can record measurements using a Peak Flow Meter at home.
5. NUTRITIONAL PLAN, it will provide a daily dietary guide to enable individuals to adapt these tools and recommendations to their specific needs.
6. MESSAGING, it is a bidirectional contact area.
Eligibility Criteria
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Inclusion Criteria
* Patients seen in the pulmonology service of the center.
* Patients who have not previously received asthma education.
* Capable of giving signed informed consent.
Exclusion Criteria
* Lack of minimum technological knowledge for the use of the application (ESTOI).
* People who are participating or have participated in a clinical trial in the last 6 months.
* Patients diagnosed with other respiratory diseases except for obstructive sleep apnea (OSA), Asthma-COPD overlap syndrome (ACOS).
* Patients with palliative or severe chronic illnesses that limit their life expectancy.
18 Years
ALL
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Héctor Cabrerizo Carreño
Principal Investigator
Principal Investigators
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Héctor Cabrerizo Carreño, M.N
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Mariana M Muñoz, M.D.
Role: STUDY_DIRECTOR
Hospital Universitari de Bellvitge
Locations
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Bellvitge University Hospital
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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References
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Related Links
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Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019
Gina Main report 2022
Difficult to control asthma: predisposing and aggravating factors
Anxiety scale HADS
Random. org
Other Identifiers
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TAPR-578/24
Identifier Type: -
Identifier Source: org_study_id
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