Educational Intervention for Asthmatic and Allergic Patients

Study Overview
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Brief Summary
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Despite its importance, there are few studies that implement the use of new technologies in the approach to patients with asthma and allergy. Therefore, the objective of this study is to evaluate the effectiveness of a telematic educational intervention in patients with allergies and / or asthma

Official Title
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Educational Intervention for Asthmatic and Allergic Patients

Conditions
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Asthma, Allergy

Intervention / Treatment
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* Behavioral: Virtual educational intervention
* Behavioral: Written educational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthmatic and allergic patients Exclusion Criteria: Cognitive impairment. Diagnose of autism spectrum disorder or severe intellectual disability Physical or functional impairment that limits the performance of evaluation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual educational intervention<br>Educational intervention about the disease, the use of medication and the context of pandemic | Behavioral: Virtual educational intervention<br>* Educational intervention about the disease, the use of medication and the context of pandemic<br>|
| Experimental: Written educational intervention<br>Educacional intervention about the disease, the use of medication and the context of pandemic | Behavioral: Written educational intervention<br>* Educational intervention about the disease, the use of medication and the context of pandemic<br>|
| No Intervention: Control intervention<br>Control intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma knowledge questionnaire | Questionnaire to evaluate the knowledge about asthma. The questionnaire consists of 23 questions, some of them with several items. In total, there are 54 possible true / false / don't know answers. Each correct answer is given the value of one point and each incorrect or unknown answer a score of 0. Thus, the score that can be obtained in total is 0-54. | Baseline | 
| Asthma knowledge questionnaire | Questionnaire to evaluate the knowledge about asthma. The questionnaire consists of 23 questions, some of them with several items. In total, there are 54 possible true / false / don't know answers. Each correct answer is given the value of one point and each incorrect or unknown answer a score of 0. Thus, the score that can be obtained in total is 0-54. | 1month | 
| Allergic rhinitis knowledge questionnaire | Questionnaire to evaluate the knowledge about Allergic rhinitis. It includes 7 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results. | Baseline | 
| Allergic rhinitis knowledge questionnaire | Questionnaire to evaluate the knowledge about Allergic rhinitis. It includes 7 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results. | 1month | 
| Inhaler technique checklist | Checklist to evaluate the technique of inhaler. It contains several items that need to be checked. If the patient has a puntuation of 0-3 it is considered poor technique; If the patien has a puntuation of 4-5 it is considered the patient has a Moderate technique and if the patient has 6-7 points the technique is Good | Baseline | 
| Inhaler technique checklist | Checklist to evaluate the technique of inhaler. It contains several items that need to be checked. If the patient has a puntuation of 0-3 it is considered poor technique; If the patien has a puntuation of 4-5 it is considered the patient has a Moderate technique and if the patient has 6-7 points the technique is Good | 1month | 
| Knowledge of COVID | Questionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results. | Baseline | 
| Knowledge of COVID | Questionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results. | 1month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control questionnaire | A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. 7 items; 1 week recall (for items on symptoms and rescue inhaler use). 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Minimally important difference: Change in score of 0.5 | Baseline | 
| Asthma control questionnaire | A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. 7 items; 1 week recall (for items on symptoms and rescue inhaler use). 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Minimally important difference: Change in score of 0.5 | 1month | 
| Allergic rhinitis control test | It is 5-item questionnaire about the control of allergic rhinitis. Questions are scored from 1 to 5 and evaluated for rhinitis during the last 2 weeks. Total score between 5 and 25. ≥ 20: Good control of rhinitis; <20: Poor control of rhinitis | Baseline | 
| Allergic rhinitis control test | It is 5-item questionnaire about the control of allergic rhinitis. Questions are scored from 1 to 5 and evaluated for rhinitis during the last 2 weeks. Total score between 5 and 25. ≥ 20: Good control of rhinitis; <20: Poor control of rhinitis | 1month | 
| Fear of COVID-19 Scale | Bangla fear of COVID (FCV19-S): It is a questionnaire that assesses the fear of COVID-19. It consists of 7 items scored on a 5-item Likert scale. The higher the score, the more fear. | Baseline | 
| Fear of COVID-19 Scale | Bangla fear of COVID (FCV19-S): It is a questionnaire that assesses the fear of COVID-19. It consists of 7 items scored on a 5-item Likert scale. The higher the score, the more fear. | 1month | 
| COVID-19 Anxiety Scale (CAS) | Coronavirus anxiety scale (CAS): It is a scale that measures the anxiety generated by COVID-19 in the last two weeks. It presents 5 items and a score> 9 indicates dysfunctional anxiety associated with the pandemic. | Baseline | 
| COVID-19 Anxiety Scale (CAS) | Coronavirus anxiety scale (CAS): It is a scale that measures the anxiety generated by COVID-19 in the last two weeks. It presents 5 items and a score> 9 indicates dysfunctional anxiety associated with the pandemic. | 1month | 
| COVID Stress Scales | COVID stress scale (CSS): is a 36-item COVID Stress Scale (CSS) to measure these features, as they pertain to COVID-19. The CSS were developed to better understand and assess COVID-19-related distress. The scales were intentionally designed so they could be readily adapted for future pandemics. | Baseline | 
| COVID Stress Scales | COVID stress scale (CSS): is a 36-item COVID Stress Scale (CSS) to measure these features, as they pertain to COVID-19. The CSS were developed to better understand and assess COVID-19-related distress. The scales were intentionally designed so they could be readily adapted for future pandemics. | 1month | 
| Feeling of Satisfaction with Inhaler | This is a 10 items self-completed questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled corticosteroids. The score ranges from 10-50 points. ≥ 43 points indicates high satisfaction; <43 points indicates low satisfaction | Baseline | 
| Feeling of Satisfaction with Inhaler | This is a 10 items self-completed questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled corticosteroids. The score ranges from 10-50 points. ≥ 43 points indicates high satisfaction; <43 points indicates low satisfaction | 1month | 
| Test of Adherence to Inhalers | 12-item questionnaire designed to assess the adherence to inhalers. The final version of the questionnaire included 12 items with two main domains, the patient (items #1 to #10) and the health professional (items #11 and #12) domain. In fact, the TAI consists of two complementary questionnaires: the 10-items TAI was designed to identify non-adherent patients and to establish the non-adherence level, whereas the 12-items TAI was designed to guide clinically the non-adherence patterns.An erratic and deliberate non-adherent behavioral pattern was defined in the presence of scores ≤24 for items #1 to #5 and items #6 to #10, respectively. The unwitting pattern was defined in the presence of a score 1 in at least one of the #11 or #12 items of the questionnaire. | Baseline | 
| Test of Adherence to Inhalers | 12-item questionnaire designed to assess the adherence to inhalers. The final version of the questionnaire included 12 items with two main domains, the patient (items #1 to #10) and the health professional (items #11 and #12) domain. In fact, the TAI consists of two complementary questionnaires: the 10-items TAI was designed to identify non-adherent patients and to establish the non-adherence level, whereas the 12-items TAI was designed to guide clinically the non-adherence patterns.An erratic and deliberate non-adherent behavioral pattern was defined in the presence of scores ≤24 for items #1 to #5 and items #6 to #10, respectively. The unwitting pattern was defined in the presence of a score 1 in at least one of the #11 or #12 items of the questionnaire. | 1month |