NCT06116292Recruiting
Impact of the Implementation of a Telemedicine Program on Patients Diagnosed with Asthma
Source: ClinicalTrials.gov · Last updated 22 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 22 Oct 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- Asthma
- NCT number
- NCT06116292
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 1 Jan 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bellvitge University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.