CClinicalTrials.gg
Status unknownNCT04928638Updated Jun 16, 2021

Educational Intervention for Asthmatic and Allergic Patients

An interventional study of Virtual educational intervention and Written educational intervention in Asthma and Allergy, sponsored by Universidad de Granada. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-16.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Asthma
  • Allergy

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's planned enrollment of 60 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Asthmatic and allergic patients

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment.
  • Diagnose of autism spectrum disorder or severe intellectual disability
  • Physical or functional impairment that limits the performance of evaluation
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Virtual educational intervention

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

    Behavioral: Virtual educational intervention

  • Experimental
    Written educational intervention

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

    Behavioral: Written educational intervention

  • No intervention
    Control intervention

    Control intervention

Interventions

  • BehavioralVirtual educational intervention

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

  • BehavioralWritten educational intervention

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 1month

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: 1month

  5. 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

    Time frame: Baseline

  6. 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

    Time frame: 1month

  7. 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.

    Time frame: Baseline

  8. 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.

    Time frame: 1month

Secondary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: 1month

  3. 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

    Time frame: Baseline

  4. 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

    Time frame: 1month

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: 1month

  7. 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.

    Time frame: Baseline

  8. 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.

    Time frame: 1month

  9. 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.

    Time frame: Baseline

  10. 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.

    Time frame: 1month

  11. 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

    Time frame: Baseline

  12. 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

    Time frame: 1month

  13. 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.

    Time frame: Baseline

  14. 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.

    Time frame: 1month

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04928638
Lead sponsor
Universidad de Granada
Responsible party
Marie Carmen Valenza (Principal Investigator; PT; PhD, Universidad de Granada) — Principal investigator
First posted
Jun 16, 2021
Start date
Jun 12, 2021 (estimated)
Primary completion
Jul 12, 2021 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
Jun 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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