Pictograms to Facilitate Comprehension of Medical Indications

Not Applicable

Terminated

Conditions: Adherence, Medication
Asthma Chronic
Primary Health Care

Interventions: Other: Usual Care
Other: SIMAP

Registration Number: NCT05609760

Lead Sponsor: Universidad de Concepcion

Brief 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.

Detailed Description: In this triple-masked randomised trial, adult participants with a recent diagnosis of asthma (\<15 days) will be allocated to receive a pictographic depiction of their medical indications or a standard description of said indications. Eligible patients will include those between 18 and 65 years of age with a diagnosis of asthma established by standard clinical recommendations (clinical and spirometric criteria as established by Global Initiative for Asthma - GINA - guidelines) and in whom therapy including a bronchodilator and a controller medication (typically an inhaled steroid) is planned to be initiated. Patients with another cause of bronchial obstruction (such as COPD), those with cognitive or visual impairments that hampers the understanding of pictograms or those with a history of alcoholism or alcohol abuse will be excluded. Patients will be randomised using a permuted block sequence which shall be kept hidden from other investigators. Participants will be followed-up at seven, thirty and sixty-day intervals using the Asthma Control Questionnaire (ACT), which is the primary outcome of this study. Participants, clinical evaluators, analysts and sponsors will be kept unaware of treatment allocation. Secondary endpoints include the inhaler technique, the correct depiction of inhaler medication purpose, the rate of emergency care visits between groups, the rate of hospitalisations between groups and the need to increase bronchodilator therapy during scheduled visits within the trial. All analyses will be conducted using the intention-to-treat principle.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 22

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Group	Usual Care	These patients will receive their medical indications in the usual way, as established by the health team of the participating clinics. In addition, these patients will receive a bronchial asthma information leaflet as part of the usual education when explaining the disease. No pictograms will be included in these leaflets.
Pictogram Group	SIMAP	This intervention consists of using a pictogram system called SIMAP which was developed and validated in previous research. Participants allocated to this arm will received a pictographic depiction of their medical indications generated by an automated system. Information will include a description of inhaler functions, inhaler technique and correct aerochamber use.

Primary Outcome Measures

Name	Time	Method
Disease Control at 60 Days	60 days	60 days after randomisation between groups using the Asthma Control Test (ACT). Min Score: 5 (indicating poor asthma control), Max Score 25 (indicating complete control). A score above 19 suggests well-controlled asthma.
Disease Control at 30 Days	30 days	Asthma control achieved at 30 days after randomisation between groups using the Asthma Control Test (ACT).Min Score: 5 (indicating poor asthma control), Max Score 25 (indicating complete control). A score above 19 suggests well-controlled asthma.
Disease Control at 7 Days	7 days	Asthma control achieved at 7 days after randomisation between groups using the Asthma Control Test (ACT). Min Score: 5 (indicating poor asthma control), Max Score 25 (indicating complete control). A score above 19 suggests well-controlled asthma.

Secondary Outcome Measures

Name	Time	Method
Inhaler Technique	60 days	Proper application of the inhaler technique.
Patient Adherence to Inhaler Technique Steps at 60 Days	60 days	To assess patients' adherence to the correct inhaler technique, a five-step checklist was created, and a nurse evaluated each patient's inhalation technique. Then, the number of participants who correctly completed each individual step was reported.

Trial Locations

Locations (4): Dirección de Administración de Hualpen
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Hualpen, Biobio, Chile
Dirección de Administración Salud de Talcahuano
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Talcahuano, Biobio, Chile
Ilustre Municipalidad de San Antonio
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San Antonio, Valparaiso, Chile
Corporación Municipal de Valparaiso
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Valparaíso, Chile