Pictograms to Facilitate Comprehension of Medical Indications

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of an Automated System of Pictograms to Facilitate Comprehension of Medical Indications: A Randomised Trial

Conditions
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Asthma Chronic, Adherence, Medication, Primary Health Care

Intervention / Treatment
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* Other: SIMAP
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial of parallel groups with triple masking amongst patients with a recent diagnosis of asthma (<=15 days) in primary care.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pictogram Group<br>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. | Other: SIMAP<br>* Pictographic depiction of medical indications alongside standard communication of these recommendations.<br>|
| Sham Comparator: Usual Care Group<br>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. | Other: Usual Care<br>* Standard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control at 60 days | 60 days after randomisation between groups using the Asthma Control Test. | 60 days | 
| Disease Control at 30 days | Asthma control achieved at 30 days after randomisation between groups using the Asthma Control Test. | 30 days | 
| Disease Control at 7 days | Asthma control achieved at 7 days after randomisation between groups using the Asthma Control Test. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaler technique | Proportion of participants displaying a correct inhaler technique between groups. | 60 days | 
| Aerochamber use | Proportion of participants using an aerochamber between groups | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma Chronic, Adherence, Medication, Primary Health Care