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Educational Intervention for Asthmatic and Allergic Patients

Educational Intervention for Asthmatic and Allergic Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04928638
Enrollment
60
Registered
2021-06-16
Start date
2021-06-12
Completion date
2021-07-30
Last updated
2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Asthma

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

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

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Asthma knowledge questionnaireBaselineQuestionnaire 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 questionnaireBaselineQuestionnaire 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 checklistBaselineChecklist 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 COVIDBaselineQuestionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.

Secondary

MeasureTime frameDescription
COVID Stress ScalesBaselineCOVID 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.
Asthma control questionnaireBaselineA 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
Test of Adherence to InhalersBaseline12-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.
Feeling of Satisfaction with InhalerBaselineThis 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
Allergic rhinitis control testBaselineIt 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 ScaleBaselineBangla 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)BaselineCoronavirus 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026