RecruitingNot ApplicableNCT06116292

Impact of the Implementation of a Telemedicine Program on Patients Diagnosed with Asthma


Sponsor

Hospital Universitari de Bellvitge

Enrollment

108 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Introduction: Asthma is one of the most common chronic respiratory diseases worldwide. Despite the extensive knowledge of the condition and available therapeutic options, severe asthmatic patients have poor disease control in 50% of cases. 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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a telemedicine (phone/internet-based) program can improve health outcomes and quality of life for patients with asthma. The app-based program provides education and remote monitoring to help patients better manage their condition. **You may be eligible if:** - You are 18 or older - You have a confirmed diagnosis of asthma (according to GEMA 2022 guidelines) - You are being cared for in the pulmonology (lung) department of the study center - You have not previously received formal asthma education - You are able to give informed consent **You may NOT be eligible if:** - You do not have a smartphone with Android or iOS - You lack basic technology skills to use the app - You are already participating or have participated in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThe 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.


Locations(1)

Bellvitge University Hospital

Barcelona, Barcelona, Spain

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NCT06116292


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