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

NCT06116292 | Recruiting

• 1 other identifier: TAPR-578/24
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Asthma; Telemedicine; Asthma Control; Quality of Live; Adherence, Treatment

Outcome Measures

Primary Outcomes (4)

• Asthma Control Test (ACT)

  ACT is a 5-item questionnaire that assesses the level of control of asthma symptoms during the previous 4 weeks. The results range from 5 to 25, where higher results indicate better control of the disease and low results indicate worse control. Results between 20 and 25 are established as good control, partial control between 16 and 19, and poor control less than 15.

  Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

• Number of exacerbations

  In asthma an exacerbation is considered a worsening of asthma symptoms that requires medical intervention and has at least 1 of the following 3 elements listed below for at least 2 consecutive days: Worsening of asthma signs/symptoms (dyspnea, wheezing, nocturnal awakenings, or chest tightness), increased use of rescue medication or deterioration of lung function.

  Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52).

• Peak Expiratory Flow (PEF)

  It will be use the PEF to to know the current lung status and the degree of asthma control. At each visit, a PEF measurement will be performed. A good control will be considered when the results obtained in PEF are greater than 80% compared to the patient's personal best.

  Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

• Forced expiratory volume in one second (FEV1)

  It will be use the FEV1 to to know the current lung status and the degree of asthma control. At each visit, a spirometry will be performed. A good control will be considered when the results obtained in these tests are greater than 80% compared to the patient's personal best or the theoretical value or zscore (-1.64).

  Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

Secondary Outcomes (4)

• Test of the Adherence to Inhalers (TAI).

  Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

• Electronic history of medication dispenses

  Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

• Asthma Quality of Life Questionnaire (AQLQ)

  Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

• The Hospital Anxiety and Depression Scale (HADS)

  Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

Study Arms (2)

Mobile application ESTOI for Asthmatic patients

EXPERIMENTAL

The intervention group will receive the usual care, in addition to having access to the ESTOI application.

Device: The mobile application ESTOI for Asthmatic patients

Standard of care

NO INTERVENTION

The intervention group will receive the usual care

Interventions

The mobile application ESTOI for Asthmatic patients DEVICE

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.

Mobile application ESTOI for Asthmatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Bellvitge University Hospital

Barcelona, Barcelona, 08907, Spain

RECRUITING

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Related Links

• Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019
• Gina Main report 2022
• Difficult to control asthma: predisposing and aggravating factors
• Anxiety scale HADS
• Random. org

MeSH Terms

Conditions

Asthma; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Health Behavior; Behavior

Study Officials

• Héctor Cabrerizo Carreño, M.N

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• Mariana M Muñoz, M.D.

  Hospital Universitari de Bellvitge

  STUDY DIRECTOR

Central Study Contacts

Héctor Cabrerizo Carreño, M.N

CONTACT

+34 677281333; hectorc95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: November 3, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)