Educational Intervention for Asthmatic and Allergic Patients

Asthma Clinical Trial

Official title:

Educational Intervention for Asthmatic and Allergic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04928638
• Other study ID #: DF0096UG
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 12, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: June 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 30, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Asthma

Intervention

Behavioral:
• Virtual educational intervention
Educational intervention about the disease, the use of medication and the context of pandemic
• Written educational intervention
Educational intervention about the disease, the use of medication and the context of pandemic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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