Recruiting

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

ClinicalTrials.gov IDNCT06116292

PhaseNA

Enrollment108

SponsorHospital Universitari de Bellvitge

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Asthma, Telemedicine, Adherence, Treatment, Quality of Life, Control

About this study

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).

Interventions

Device: 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.

Primary outcomes

Asthma Control Test (ACT) (Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52))
Number of exacerbations (Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52).)
Peak Expiratory Flow (PEF) (Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52))
Forced expiratory volume in one second (FEV1) (Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52))

Eligibility information

Inclusion Criteria: * Age ≥18 years with a diagnosis of asthma based on GEMA 5.2 2022. * 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: * Patient who does not have a mobile device with Android or IOS system. * 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.

Study locations

Bellvitge University Hospital, Barcelona, Barcelona 08907 Spain

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.