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Recruiting
NCT05609760
Pictograms to Facilitate Comprehension of Medical Indications
Conditions: Asthma Chronic, Adherence, Medication, Primary Health Care
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 48
Sponsor: Universidad de Concepcion
Location: Chile
Summary
SIMAP is a triple-masked randomised trial aimed at assessing whether an automated system of pictograms associated to medical indications results in better comprehension and adherence of said indications.
Adult patients with a recent diagnosis of asthma will be randomised to receive a pictographic depiction of their treatments and recommended interventions or standard communication without assistance from their attending physician.
Patients will be followed-up for 60 days using the Asthma Control Questionnaire (ACT).
The primary endpoint of this study is the degree of asthma control as assessed by the aforementioned questionnaire.
Secondary outcomes include the number of hospitalisations, emergency care unit visits and the need to increase bronchodilator therapy as per current Global Initiative for Asthma guidelines.
Outcomes will be analysed under the intention-to-treat principle by a statistician unaware of treatment allocation.
Eligibility Criteria
Inclusion Criteria:Adult patients aged 18 to 65 years with a recent diagnosis of bronchial asthma (<=15 days) based on 2018 Global Initiative For Asthma (GINA) criteria.Diagnosis substantiated clinically and with consistent spirometry results as established by current GINA guidelines.Patients who are to initiate bronchodilator treatment, including at least one inhaled corticosteroid and one short-acting bronchodilator.Exclusion Criteria:Patients presenting obstructive bronchial pathology other than bronchial asthma (chronic obstructive pulmonary disease, mixed states, etc.),Patients who have participated in the pictogram design phase (Stage 1 of the project),Patients with a diagnosis of dementia, diagnosis of harmful use of alcohol and other drugs according to the International Classification of Diseases (ICD-10).Patients with significant ophthalmologic pathology that prevents the use of pictograms.Patients who do not wish to participate in the project.
Source: ClinicalTrials.gov (NCT05609760). StuddyBuddy aggregates publicly available trial information.