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AsthmaNCT06116292

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

A study testing The mobile application ESTOI for Asthmatic patients in people with Asthma and Telemedicine, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma, Telemedicine, Adherence, Treatment
What is being tested?
The mobile application ESTOI for Asthmatic patients
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteSpain
Study dates
1 Jan 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Héctor Cabrerizo Carreño, M.N contact

+34 677281333

hectorc95@gmail.com

Spain1 site, 1 recruiting

  • Bellvitge University Hospital

    Barcelona, Barcelona, 08907

    Recruiting

Other trials in Spain

About this study

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).

Read the 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.

Being tested
The mobile application ESTOI for Asthmatic patients
Keywords
Asthma, Telemedicine, Asthma Control, Quality of Live, Adherence, Treatment
Medical subject headings
Asthma, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The mobile application ESTOI for Asthmatic patientsDevice

    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.
Study groups in NCT06116292
Study groupRoleWhat they receive
Mobile application ESTOI for Asthmatic patientsExperimentalThe intervention group will receive the usual care, in addition to having access to the ESTOI application.
Receives: Device: The mobile application ESTOI for Asthmatic patients
Standard of careNo interventionThe intervention group will receive the usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

Secondary outcomes (4)

  1. Test of the Adherence to Inhalers (TAI).

    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).

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

  2. Electronic history of medication dispenses

    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.

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

  3. Asthma Quality of Life Questionnaire (AQLQ)

    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.

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

  4. The Hospital Anxiety and Depression Scale (HADS)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06116292
Sponsor's protocol ID
TAPR-578/24
Status last verified
Oct 2024
First submitted
22 Oct 2023
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32460752

  • Guan Z, Sun L, Xiao Q, Wang Y. Constructing an assessment framework for the quality of asthma smartphone applications. BMC Med Inform Decis Mak. 2019 Oct 15;19(1):192. doi: 10.1186/s12911-019-0923-8.

    PubMed 31615493

  • Farzandipour M, Nabovati E, Heidarzadeh Arani M, Akbari H, Sharif R, Anvari S. Enhancing Asthma Patients' Self-Management through Smartphone-Based Application: Design, Usability Evaluation, and Educational Intervention. Appl Clin Inform. 2019 Oct;10(5):870-878. doi: 10.1055/s-0039-1700866. Epub 2019 Nov 13.

    PubMed 31724144

  • Morrison D, Wyke S, Agur K, Cameron EJ, Docking RI, Mackenzie AM, McConnachie A, Raghuvir V, Thomson NC, Mair FS. Digital asthma self-management interventions: a systematic review. J Med Internet Res. 2014 Feb 18;16(2):e51. doi: 10.2196/jmir.2814.

    PubMed 24550161

  • Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, Price D. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009 Mar;18(1):41-9. doi: 10.4104/pcrj.2009.00010.

    PubMed 19240948

  • Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.

    PubMed 26230150

  • Perpina M, Belloch A, Pascual LM, de Diego A, Compte L. [The quality of life in asthma: an evaluation of the AQLQ questionnaire for its use on a Spanish population. Asthma Quality of Life Questionnaire]. Arch Bronconeumol. 1995 May;31(5):211-8. doi: 10.1016/s0300-2896(15)30926-1. Spanish.

    PubMed 7788082

  • Reddel HK, Marks GB, Jenkins CR. When can personal best peak flow be determined for asthma action plans? Thorax. 2004 Nov;59(11):922-4. doi: 10.1136/thx.2004.023077.

    PubMed 15516464

Questions about this trial

What is this clinical trial studying?

A study testing The mobile application ESTOI for Asthmatic patients in people with Asthma and Telemedicine, run by Hospital Universitari de Bellvitge at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Héctor Cabrerizo Carreño, M.N (+34 677281333, hectorc95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Control Test (ACT) (time frame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06116292, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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