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

Обзор

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).

Подробное описание

Design: A 52-week randomized clinical trial will be conducted, using a single-blind approach, in patients with asthma. There will be two study arms: the control cohort will receive standard care, while the intervention group will also have access to the mobile application (ESTOI).

Setting and Subjects: The study will take place in the pulmonology department of Bellvitge University Hospital in Barcelona, during the years 2024-2026.

Procedure and Instruments: The project will be structured into three visits. During the first visit, all participants will be seen by the pulmonologist at our center for asthma classification, inhaler updates, and requests for additional tests. Subsequently, the control group will receive health education (provided by the asthma specialist nurse) regarding their condition, treatment plan, signs of alarm, action plan, and a review of asthma triggers. On the other hand, intervention group patients, in addition to health education, will be introduced to the ESTOI application database and provided access to the patient portal, where patients will find all the necessary information on asthma management. Both groups will receive a Peakflow meter and instructions on its use and record-keeping.

A nurse will be responsible for managing and monitoring the patients using the application. Patients will also schedule and review the medical records of all patients included in the study and review the data collection notebooks and informed consents. The asthma specialist nurse will be responsible for conducting the questionnaires, collecting data for the Case Report Form (CRF), performing laboratory tests, and conducting respiratory functional tests.

During the three study visits, all included patients will complete the study questionnaires: Asthma Control Test (ACT), Inhaler Adherence Test (TAI), Asthma Quality of Life Questionnaire (AQLQ), and the Hospital Anxiety and Depression Scale (HAD). Afterward, the electronic history of medication dispenses will be reviewed, exhaled nitric oxide (FeNO) will be measured, a spirometry test with bronchodilator response, a control blood test, and an on-site measurement of Peak Expiratory Flow (PEF) using the Peakflow meter will be conducted.

At the end of the first visit, all participants will be scheduled for the next visit and provided with a contact phone number in case the patients have any questions or issues.

Upon completion of the third visit, the intervention group will be given a satisfaction questionnaire for having used the application."

All relevant study data will be recorded in each patient's data collection notebook for subsequent analysis. These notebooks will be stored at the center in a locked room accessible only to the research team. Sociodemographic variables will be collected by the asthma unit nurse during the first study visit.

Information about the current state of asthma will be obtained through questionnaires, respiratory functional tests, laboratory tests, and a review of the patient's medical history.

Data Analysis: Continuous variables will be expressed as mean and standard deviation in case of a normal distribution, and as median and interquartile range in case of a non-normal distribution. Qualitative variables will be presented as frequencies and percentages. For the comparison of continuous variables, analysis of variance (ANOVA) or the Kruskal-Wallis test will be used. The chi-square test will be performed for the analysis of the primary outcome variable. Stepwise logistic regression models will be used to select the subgroup of parameters significantly associated with poor asthma control. A priori, the factors included in the analysis will be age, asthma duration, education level, BMI, smoking, environmental exposure, pre-BD FEV1, post-BD FEV1, FeNO, blood eosinophilia, general and specific blood IgE levels, ACT, TAI, HAD, AQLQ, the number of exacerbations, and control of comorbidities affecting asthma (GERD, rhinitis, polyps, overweight/obesity, and smoking). Statistical significance will be assumed at p \< 0.05.

Вмешательства

• Устройство 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 an

Первичные конечные точки

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

Вторичные конечные точки (4)

• Test of the Adherence to Inhalers (TAI). [Срок оценки: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)]
• Electronic history of medication dispenses [Срок оценки: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)]
• Asthma Quality of Life Questionnaire (AQLQ) [Срок оценки: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)]
• The Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Bellvitge University Hospital — Barcelona

Публикации

• GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16. PMID 28822787
• Plaza V, Quirce S, Delgado J, Martinez Moragon E, Perez de Llano L; Grupo multidisciplinar de expertos "Asmaforum". [Multidisciplinary expert discussion. Uncontrolled asthma: causes, consequences and possible solutions]. An Sist Sanit Navar. 2016 Nov 21;39(3):357-370. doi: 10.23938/ASSN.0233. Spanish. PMID 28032871
• Rabe KF, Adachi M, Lai CK, Soriano JB, Vermeire PA, Weiss KB, Weiss ST. Worldwide severity and control of asthma in children and adults: the global asthma insights and reality surveys. J Allergy Clin Immunol. 2004 Jul;114(1):40-7. doi: 10.1016/j.jaci.2004.04.042. PMID 15241342
• Quirce S, Plaza V, Picado C, Vennera M, Casafont J. Prevalence of uncontrolled severe persistent asthma in pneumology and allergy hospital units in Spain. J Investig Allergol Clin Immunol. 2011;21(6):466-71. PMID 21995180
• Almonacid Sanchez C, Blanco Aparicio M, Dominguez Ortega J, Giner Donaire J, Molina Paris J, Sanchez Marcos N, Plaza V. [Multidisciplinary Consensus for the Monitoring and Control of Asthma Through Telemedicine. The COMETA Project]. Open Respir Arch. 2021 Apr 19;3(2):100098. doi: 10.1016/j.opresp.2021.100098. eCollection 2021 Apr-Jun. Spanish. PMID 37497073
• Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2. PMID 24282112
• Hollenbach JP, Cushing A, Melvin E, McGowan B, Cloutier MM, Manice M. Understanding clinicians' attitudes toward a mobile health strategy to childhood asthma management: A qualitative study. J Asthma. 2017 Sep;54(7):754-760. doi: 10.1080/02770903.2016.1263649. Epub 2016 Nov 23. PMID 27880049
• Munteanu LA, Frandes M, Timar B, Tudorache E, Fildan AP, Oancea C, Tofolean DE. The efficacy of a mobile phone application to improve adherence to treatment and self-management in people with chronic respiratory disease in Romanian population - a pilot study. BMC Health Serv Res. 2020 May 27;20(1):475. doi: 10.1186/s12913-020-05340-0. PMID 32460752

Идентификаторы

NCT: NCT06116292 · TAPR-578/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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