Pictograms to Facilitate Comprehension of Medical Indications (SIMAP)

December 6, 2022 updated by: Universidad de Concepcion

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: María A Rodriguez, PhD
  • Phone Number: +56 41 2204302
  • Email: secrevrid@udec.cl

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pictogram Group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control at 60 days
Time Frame: 60 days
60 days after randomisation between groups using the Asthma Control Test.
60 days
Disease Control at 30 days
Time Frame: 30 days
Asthma control achieved at 30 days after randomisation between groups using the Asthma Control Test.
30 days
Disease Control at 7 days
Time Frame: 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
Time Frame: 60 days
Proportion of participants displaying a correct inhaler technique between groups.
60 days
Aerochamber use
Time Frame: 60 days
Proportion of participants using an aerochamber between groups
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Concepcion

Collaborators

Universidad de Valparaiso
Comisión Nacional de Investigación Científica y Tecnológica
Servicio de Salud Talcahuano
ILUSTRE MUNICIPALIDAD DE HUALPEN
Dirección de Administración de Salud Municipal de Talcahuano

Investigators

  • Study Director: Rosa L Figueroa, PhD, Universidad de Concepcion
  • Study Director: Carla Taramasco, PhD, Universidad de Valparaiso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FONDEFID19I10120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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