Pictograms to Facilitate Comprehension of Medical Indications

Adherence, Medication Clinical Trial

— SIMAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609760
• Other study ID #: FONDEFID19I10120
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2022
• Source: Universidad de Concepcion
• Contact: Rosa L Figueroa, ScD
• Phone: +56 9 924956932
• Email: rosa.figueroa[@]biomedica.udec.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Medication
• Asthma
• Asthma Chronic
• Primary Health Care

Intervention

Other:
• SIMAP
Pictographic depiction of medical indications alongside standard communication of these recommendations.
• Usual Care
Standard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well.

Locations

Country	Name	City	State
Chile	Dirección de Administración de Hualpen	Hualpen	Biobio
Chile	Ilustre Municipalidad de San Antonio	San Antonio	Valparaiso
Chile	Dirección de Administración Salud de Talcahuano	Talcahuano	Biobio
Chile	Corporación Municipal de Valparaiso	Valparaíso

Sponsors (6)

Lead Sponsor	Collaborator
Universidad de Concepcion	Comisión Nacional de Investigación Científica y Tecnológica, Dirección de Administración de Salud Municipal de Talcahuano, ILUSTRE MUNICIPALIDAD DE HUALPEN, Servicio de Salud Talcahuano, Universidad de Valparaiso

Country where clinical trial is conducted

Chile, 

References & Publications (5)

Alvear G, Figueroa L, Hurtado G, Moyano L. Evaluación del grado de control del asma en un centro de atención primaria. Un estudio descriptivo. Rev. chil. enferm. respir. 2016; 32 (2): 68-76. Spanish.

Barros IM, Alcantara TS, Mesquita AR, Bispo ML, Rocha CE, Moreira VP, Lyra Junior DP. Understanding of pictograms from the United States Pharmacopeia Dispensing Information (USP-DI) among elderly Brazilians. Patient Prefer Adherence. 2014 Oct 29;8:1493-501. doi: 10.2147/PPA.S65301. eCollection 2014. — View Citation

Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008. — View Citation

Perez-Yarza EG, Castro-Rodriguez JA, Villa Asensi JR, Garde Garde J, Hidalgo Bermejo FJ; Grupo VESCASI. [Validation of a Spanish version of the Childhood Asthma Control Test (Sc-ACT) for use in Spain]. An Pediatr (Barc). 2015 Aug;83(2):94-103. doi: 10.1016/j.anpedi.2014.10.031. Epub 2014 Dec 30. Spanish. — View Citation

Reddel HK, Bacharier LB, Bateman ED, Brightling CE, Brusselle GG, Buhl R, Cruz AA, Duijts L, Drazen JM, FitzGerald JM, Fleming LJ, Inoue H, Ko FW, Krishnan JA, Levy ML, Lin J, Mortimer K, Pitrez PM, Sheikh A, Yorgancioglu AA, Boulet LP. Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes. Am J Respir Crit Care Med. 2022 Jan 1;205(1):17-35. doi: 10.1164/rccm.202109-2205PP. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control at 60 days	60 days after randomisation between groups using the Asthma Control Test.	60 days
Primary	Disease Control at 30 days	Asthma control achieved at 30 days after randomisation between groups using the Asthma Control Test.	30 days
Primary	Disease Control at 7 days	Asthma control achieved at 7 days after randomisation between groups using the Asthma Control Test.	7 days
Secondary	Inhaler technique	Proportion of participants displaying a correct inhaler technique between groups.	60 days
Secondary	Aerochamber use	Proportion of participants using an aerochamber between groups	60 days

External Links

•   Chilean Guide for Asthma Treatment