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

October 20, 2024 updated by: Héctor Cabrerizo Carreño, Hospital Universitari de Bellvitge

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • Bellvitge University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile application ESTOI for Asthmatic patients
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

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.
No Intervention: Standard of care
The intervention group will receive the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Test (ACT)
Time Frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
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
Time Frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52).
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)
Time Frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
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)
Time Frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test of the Adherence to Inhalers (TAI).
Time Frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
TAI is a 12-item questionnaire that assesses adherence to inhalers for patients with Asthma or COPD. Thus, if the healthcare professional only wants to assess adherence and its intensity, patients should use the 10-item TAI. If he also wants to assess the type of non-compliance, he can use the 12-item TAI. The type or pattern of non-compliance will be assessed as follows: Items 1 to 5 assess "erratic" non-compliance (score between 5 and 25), items 6 to 10 assess "deliberate" non-compliance (score between 5 and 25) and items 11 and 12 assess "unconscious" non-compliance (score between 2 and 4).
Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
Electronic history of medication dispenses
Time Frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
In order to assess treatment adherence, the electronic history of medication dispenses will be reviewed. The investigator could see how many times the patient draws his treatment each month. This will help to observe if treatment compliance is optimal, but it should be used in conjunction with the TAI to ensure the results.
Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
Asthma Quality of Life Questionnaire (AQLQ)
Time Frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
AQLQ is a 32-item questionnaire that assesses the quality of life of patients with asthma. Covers 4 dimensions (breathlessness, mood, social limitation and worrying). Answers are given on a scale of 7 points, where 1 = maximum limitation and 7 = absence of limitation. The questionnaire provides an overall score, which is the average for all items, and a score for each dimension, which is the average of the corresponding items.
Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
The Hospital Anxiety and Depression Scale (HADS)
Time Frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
HADS is a questionnaire for detecting affective disorders in hospital settings with outpatients. Is frequently used to evaluate populations with chronic diseases. It consists of 14 items. Odd items configure the subscale of anxiety and its response scale is scored from 3 to 0. The pairs make up the depression subscale and are scored from 0 to 3. The total score on each subscale is obtained by adding those of the corresponding items, with each range from 0 to 21. In both cases, the higher the score, the higher the level of anxiety or depression.
Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: Héctor Cabrerizo Carreño, M.N, Hospital Universitari de Bellvitge
  • Study Director: Mariana M Muñoz, M.D., Hospital Universitari de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 20, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAPR-578/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At the moment, the investigator team have not yet decided whether to make all the patient data collected in this study available to other researchers. If the investigator do choose to share the data, it would include sociodemographic information, data collected from the questionnaires administered throughout the study, results obtained from pulmonary function tests (also obtained through the mobile app), the number of app logins, video views, questionnaire response rates, peak expiratory flow (PEF) records, the number of consultations with healthcare professionals through the app, and analytical parameters. When the results have been published, the principal investigator will consider whether it would be beneficial to present all of these findings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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