Impact of the Implementation of a Telemedicine Program on Patients Diagnosed with Asthma
NCT06116292 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2024-10-22
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).
Conditions
- Asthma
- Telemedicine
- Adherence, Treatment
- Quality of Life
- Control
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.
Sponsors & Collaborators
-
Hospital Universitari de Bellvitge
lead OTHER
Principal Investigators
-
Héctor Cabrerizo Carreño, M.N · Hospital Universitari de Bellvitge
-
Mariana M Muñoz, M.D. · Hospital Universitari de Bellvitge
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Spain
Study Locations
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