Impact of the Implementation of a Telemedicine Program on Patients Diagnosed with Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
The mobile application ESTOI for Asthmatic patients
DeviceThe 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.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Mobile application ESTOI for Asthmatic patientsExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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).
Time frame
Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)Secondary outcomes
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).
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)Sponsors and contacts
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Source ClinicalTrials.gov