Educational Intervention for Asthmatic and Allergic Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma; Allergy
• Intervention / Treatment: Behavioral: Virtual educational intervention; Behavioral: Written educational intervention

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual educational intervention; Educational intervention about the disease, the use of medication and the context of pandemic	Behavioral: Virtual educational intervention; Educational intervention about the disease, the use of medication and the context of pandemic
Experimental: Written educational intervention; Educacional intervention about the disease, the use of medication and the context of pandemic	Behavioral: Written educational intervention; Educational intervention about the disease, the use of medication and the context of pandemic
No Intervention: Control intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	1month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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
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.	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.	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.	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

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Anticipated): June 12, 2021
• Primary Completion (Anticipated): July 12, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: DF0096UG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No