Clinical trial NCT05609760: Pictograms to Facilitate Comprehension of Medical Indications
Official title: Effects of an Automated System of Pictograms to Facilitate Comprehension of Medical Indications: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma Chronic
Adherence, Medication
Primary Health Care
Keywords: Asthma Chronic
Adherence, Medication
Primary Health Care
Lead sponsor: Universidad de Concepcion
Sponsor class: OTHER
Collaborators: name: Universidad de Valparaiso
name: Comisión Nacional de Investigación Científica y Tecnológica
name: Servicio de Salud Talcahuano
name: ILUSTRE MUNICIPALIDAD DE HUALPEN
name: Dirección de Administración de Salud Municipal de Talcahuano
First posted: 2022-11-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial of parallel groups with triple masking amongst patients with a recent diagnosis of asthma (\<=15 days) in primary care.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Disease Control at 60 Days
timeFrame: 60 days
measure: Disease Control at 30 Days
timeFrame: 30 days
measure: Disease Control at 7 Days
timeFrame: 7 days
Secondary outcomes:
measure: Inhaler Technique
timeFrame: 60 days
measure: Patient Adherence to Inhaler Technique Steps at 60 Days
timeFrame: 60 days
Other outcomes:
Locations:
city: Hualpen
country: Chile
facility: Dirección de Administración de Hualpen
state: Biobio
city: Talcahuano
country: Chile
facility: Dirección de Administración Salud de Talcahuano
state: Biobio
city: San Antonio
country: Chile
facility: Ilustre Municipalidad de San Antonio
state: Valparaiso
city: Valparaíso
country: Chile
facility: Corporación Municipal de Valparaiso
Study officials:
affiliation: Universidad de Concepcion
name: Rosa L Figueroa, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Valparaiso
name: Carla Taramasco, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.
citation: 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.