NCT04928638

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable asthma

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

March 25, 2021

Last Update Submit

June 10, 2021

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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.

    Baseline

  • 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 Outcomes (14)

  • Asthma control questionnaire

    Baseline

  • Asthma control questionnaire

    1month

  • Allergic rhinitis control test

    Baseline

  • Allergic rhinitis control test

    1month

  • Fear of COVID-19 Scale

    Baseline

  • +9 more secondary outcomes

Study Arms (3)

Virtual educational intervention

EXPERIMENTAL

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

Behavioral: Virtual educational intervention

Written educational intervention

EXPERIMENTAL

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

Behavioral: Written educational intervention

Control intervention

NO INTERVENTION

Control intervention

Interventions

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

Virtual educational intervention

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

Written educational intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asthmatic and allergic patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaHypersensitivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; PT; PhD

Study Record Dates

First Submitted

March 25, 2021

First Posted

June 16, 2021

Study Start

June 12, 2021

Primary Completion

July 12, 2021

Study Completion

July 30, 2021

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share