Pictograms to Facilitate Comprehension of Medical Indications

NCT05609760 | Terminated Results DMC

• 1 other identifier: FONDEFID19I10120
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

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.

Conditions

Asthma Chronic; Adherence, Medication; Primary Health Care

Keywords

Asthma Chronic; Adherence, Medication; Primary Health Care

Outcome Measures

Primary Outcomes (3)

• Disease Control at 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.

  60 days

• Disease Control at 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.

  30 days

• Disease Control at 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.

  7 days

Secondary Outcomes (2)

• Inhaler Technique

  60 days

• Patient Adherence to Inhaler Technique Steps at 60 Days

  60 days

Study Arms (2)

Pictogram Group

EXPERIMENTAL

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

Usual Care Group

SHAM COMPARATOR

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

Interventions

SIMAP OTHER

Pictographic depiction of medical indications alongside standard communication of these recommendations.

Pictogram Group

Usual Care OTHER

Standard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well.

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Concepcion: lead
• Universidad de Valparaiso: collaborator
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator
• Servicio de Salud Talcahuano: collaborator
• ILUSTRE MUNICIPALIDAD DE HUALPEN: collaborator
• Dirección de Administración de Salud Municipal de Talcahuano: collaborator

Study Sites (4)

Ilustre Municipalidad de San Antonio

San Antonio, Región de Valparaíso, Chile

Location

Dirección de Administración de Hualpen

Hualpén, Región del Biobío, Chile

Location

Dirección de Administración Salud de Talcahuano

Talcahuano, Región del Biobío, Chile

Location

Corporación Municipal de Valparaiso

Valparaíso, Chile

Location

Related Publications (5)

• 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.

  PMID: 34658302 BACKGROUND

• 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.

  PMID: 14713908 BACKGROUND

• 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.

  PMID: 25555366 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25378914 BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Unfortunately, the progression of the COVID-19 health crisis led to the suspension of this study. In response to the unprecedented circumstances, the study protocol underwent necessary amendments related to COVID-19 before resuming. The revised protocol with amendments received approval. Due to the shift in priorities caused by the COVID-19 crisis, the flow of patients diagnosed with bronchial asthma was lower than anticipated in the study.

Results Point of Contact

• Title: Rosa Figueroa I, Associate Professor
• Organization: Universidad de concepción

rosa.figueroa@biomedica.udec.cl

+56412204247

Study Officials

• Rosa L Figueroa, PhD

  Universidad de Concepcion

  STUDY DIRECTOR

• Carla Taramasco, PhD

  Universidad de Valparaiso

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, clinical investigators, outcome assessors, analysts and sponsors will be kept unaware of treatment allocation. The masking of the participating patients will be carried out through an informative brochure on bronchial asthma delivered as part of the usual education, albeit without using pictograms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Académica

Model Details: Randomized clinical trial of parallel groups with triple masking amongst patients with a recent diagnosis of asthma (\<=15 days) in primary care.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: November 8, 2022
• Study Start: August 1, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (4)