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Educational Intervention for Asthmatic and Allergic Patients

Primary Purpose

Asthma, Allergy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual educational intervention
Written educational intervention
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Virtual educational intervention

    Written educational intervention

    Control intervention

    Arm Description

    Educational intervention about the disease, the use of medication and the context of pandemic

    Educacional intervention about the disease, the use of medication and the context of pandemic

    Control intervention

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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
    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
    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.
    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.

    Secondary Outcome Measures

    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
    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
    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
    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
    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.
    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.
    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.
    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.
    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.
    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.
    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
    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
    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.
    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.

    Full Information

    First Posted
    March 25, 2021
    Last Updated
    June 10, 2021
    Sponsor
    Universidad de Granada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04928638
    Brief Title
    Educational Intervention for Asthmatic and Allergic Patients
    Official Title
    Educational Intervention for Asthmatic and Allergic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 12, 2021 (Anticipated)
    Primary Completion Date
    July 12, 2021 (Anticipated)
    Study Completion Date
    July 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Granada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Allergy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual educational intervention
    Arm Type
    Experimental
    Arm Description
    Educational intervention about the disease, the use of medication and the context of pandemic
    Arm Title
    Written educational intervention
    Arm Type
    Experimental
    Arm Description
    Educacional intervention about the disease, the use of medication and the context of pandemic
    Arm Title
    Control intervention
    Arm Type
    No Intervention
    Arm Description
    Control intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual educational intervention
    Intervention Description
    Educational intervention about the disease, the use of medication and the context of pandemic
    Intervention Type
    Behavioral
    Intervention Name(s)
    Written educational intervention
    Intervention Description
    Educational intervention about the disease, the use of medication and the context of pandemic
    Primary Outcome Measure Information:
    Title
    Asthma knowledge questionnaire
    Description
    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.
    Time Frame
    Baseline
    Title
    Asthma knowledge questionnaire
    Description
    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.
    Time Frame
    1month
    Title
    Allergic rhinitis knowledge questionnaire
    Description
    Questionnaire to evaluate the knowledge about Allergic rhinitis. It includes 7 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.
    Time Frame
    Baseline
    Title
    Allergic rhinitis knowledge questionnaire
    Description
    Questionnaire to evaluate the knowledge about Allergic rhinitis. It includes 7 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.
    Time Frame
    1month
    Title
    Inhaler technique checklist
    Description
    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
    Time Frame
    Baseline
    Title
    Inhaler technique checklist
    Description
    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
    Time Frame
    1month
    Title
    Knowledge of COVID
    Description
    Questionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.
    Time Frame
    Baseline
    Title
    Knowledge of COVID
    Description
    Questionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.
    Time Frame
    1month
    Secondary Outcome Measure Information:
    Title
    Asthma control questionnaire
    Description
    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
    Time Frame
    Baseline
    Title
    Asthma control questionnaire
    Description
    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
    Time Frame
    1month
    Title
    Allergic rhinitis control test
    Description
    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
    Time Frame
    Baseline
    Title
    Allergic rhinitis control test
    Description
    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
    Time Frame
    1month
    Title
    Fear of COVID-19 Scale
    Description
    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.
    Time Frame
    Baseline
    Title
    Fear of COVID-19 Scale
    Description
    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.
    Time Frame
    1month
    Title
    COVID-19 Anxiety Scale (CAS)
    Description
    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.
    Time Frame
    Baseline
    Title
    COVID-19 Anxiety Scale (CAS)
    Description
    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.
    Time Frame
    1month
    Title
    COVID Stress Scales
    Description
    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.
    Time Frame
    Baseline
    Title
    COVID Stress Scales
    Description
    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.
    Time Frame
    1month
    Title
    Feeling of Satisfaction with Inhaler
    Description
    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
    Time Frame
    Baseline
    Title
    Feeling of Satisfaction with Inhaler
    Description
    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
    Time Frame
    1month
    Title
    Test of Adherence to Inhalers
    Description
    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.
    Time Frame
    Baseline
    Title
    Test of Adherence to Inhalers
    Description
    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.
    Time Frame
    1month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Educational Intervention for Asthmatic and Allergic Patients

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