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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116292
• Other study ID #: TAPR-578/24
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Hospital Universitari de Bellvitge
• Contact: Héctor Cabrerizo Carreño, M.N
• Phone: +34 677281333
• Email: hectorc95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Treatment
• Asthma
• Control
• Quality of Life
• Telemedicine

Intervention

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: SYMPTOM CONTROL, it will record the ACT, TAI, the number of exacerbations, weight, and, depending on the case, symptom control for comorbidities. 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. 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. PEAK FLOW, the patient can record measurements using a Peak Flow Meter at home. NUTRITIONAL PLAN, it will provide a daily dietary guide to enable individuals to adapt these tools and recommendations to their specific needs. MESSAGING, it is a bidirectional contact area.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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).
Primary	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)
Primary	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	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).	Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
Secondary	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.	Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
Secondary	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.	Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
Secondary	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.	Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)

External Links

•   Anxiety scale HADS
•   Difficult to control asthma: predisposing and aggravating factors
•   GEMA 5.2
•   Gina Main report 2022
•   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
•   Granmo 7.12
•   Random. org