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

Recruiting now · Not applicable

Conditions studied: Asthma, Telemedicine, Adherence, Treatment, Quality of Life, Control

In brief

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).

Key facts

Study ID

NCT06116292

Run by

Hospital Universitari de Bellvitge

People needed

108

Starts

2024-01-01

Expected to finish

2026-12-31

Last updated by the study team

2024-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bellvitge University Hospital — Barcelona, Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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