Asthma ChronicSIMAPNCT05609760

Pictograms to Facilitate Comprehension of Medical Indications

A study testing SIMAP in people with Asthma Chronic and Adherence, Medication, run by Universidad de Concepcion at 4 sites in Chile.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma Chronic, Adherence, Medication, Primary Health Care
What is being tested?: SIMAP
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 4 sitesChile
Study dates: 1 Aug 2022to 20 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

Chile4 sites

Dirección de Administración de Hualpen
Hualpén, Biobio
Ilustre Municipalidad de San Antonio
San Antonio, Valparaiso
Dirección de Administración Salud de Talcahuano
Talcahuano, Biobio
Corporación Municipal de Valparaiso
Valparaíso

Other trials in Chile

About this study

Official title: 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.

Read the 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.

Conditions: Asthma Chronic, Adherence, Medication, Primary Health Care
Being tested: SIMAP, Usual Care
Keywords: Asthma Chronic, Adherence, Medication, Primary Health Care
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SIMAPOther
Pictographic depiction of medical indications alongside standard communication of these recommendations.
Usual CareOther
Standard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well.

Study groups in NCT05609760
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 7 days

Secondary outcomes (2)

Inhaler Technique
Proper application of the inhaler technique.
Measured: 60 days
Patient Adherence to Inhaler Technique Steps at 60 Days
To assess patients' adherence to the correct inhaler technique, a five-step checklist was created, and a nurse evaluated each patient's inhalation technique. Then, the number of participants who correctly completed each individual step was reported.
Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202220 Feb 2023

First posted8 Nov 2022
Study start1 Aug 2022
Primary completion20 Feb 2023
Study completion20 Feb 2023

Why it stopped: Since the respiratory units have had to admit patients with covid sequelae or readmit former patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Asthma ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05609760
Sponsor's protocol ID: FONDEFID19I10120
Acronym: SIMAP
Status last verified: Apr 2025
First submitted: 6 Sep 2022
Last updated: 17 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34658302
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.
PubMed 14713908
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.
PubMed 25555366
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.
PubMed 25378914

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of an Automated System of Pictograms to Facilitate Comprehension of Medical Indications: A Randomised Trial
ClinicalTrials.gov ID: NCT05609760
Acronym / sponsor ID: SIMAP / FONDEFID19I10120
Conditions: Asthma Chronic, Adherence, Medication, Primary Health Care
Keywords: Asthma Chronic, Adherence, Medication, Primary Health Care
Study type: Interventional
Recruitment status: TerminatedReason stopped: Since the respiratory units have had to admit patients with covid sequelae or readmit former patients
Enrolment: 22 participants (actual)
Lead sponsor: Universidad de ConcepcionUniversity, hospital or other
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
Study start: 1 Aug 2022 (actual)
Primary completion: 20 Feb 2023 (actual)
Study completion: 20 Feb 2023 (actual)
First posted: 8 Nov 2022 (actual)
Results: Posted 17 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized clinical trial of parallel groups with triple masking amongst patients with a recent diagnosis of asthma (<=15 days) in primary care.

Arm	Type	Receives
Pictogram Group	Experimental	Other: SIMAPThis 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.
Usual Care Group	Sham comparator	Other: Usual CareThese 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SIMAPPictographic depiction of medical indications alongside standard communication of these recommendations.	Other	Pictogram Group
Usual CareStandard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well.	Other	Usual Care Group

Primary outcome

Disease Control at 60 Days
Time frame: 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.
Disease Control at 30 Days
Time frame: 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.
Disease Control at 7 Days
Time frame: 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.

2 secondary outcomes

Inhaler Technique
Time frame: 60 days
Patient Adherence to Inhaler Technique Steps at 60 Days
Time frame: 60 days

Results and safety

Results posted to the registry on 17 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pictogram Group	10	9
Usual Care Group	12	11

Primary outcome: Disease Control at 60 Days

Time frame: 60 days. Median (Inter-Quartile Range). Unit: Median of ACT score

Measure	Pictogram Group n = 9	Usual Care Group n = 11
Value	22 (18 to 22)	21 (18 to 23)

Population analysed: We recruited 10 patients, who voluntarily signed the informed consent. One patient withdrew from the study after signing the informed consent, and we lost contact with another patient during the 30-day follow-up. Consequently, we were able to analyze 21 patients in the first control (7 days of follow-up) and 20 patients in the second and third follow-ups (30 days).

Primary outcome: Disease Control at 30 Days

Time frame: 30 days. Median (Inter-Quartile Range). Unit: Median of ACT score

Measure	Pictogram Group n = 9	Usual Care Group n = 11
Value	22 (18 to 23)	23 (18 to 25)

Primary outcome: Disease Control at 7 Days

Time frame: 7 days. Median (Inter-Quartile Range). Unit: Median of ACT score

Measure	Pictogram Group n = 9	Usual Care Group n = 12
Value	19 (14 to 19)	20 (15 to 22)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the day the intervention was applied until the end of the follow-up period (60 days). Patients were provided with the principal investigator's phone number to report any adverse events that occurred after the 60-day period. No adverse events were reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pictogram Group	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Usual Care Group	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34658302Reddel 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.
Background: PubMed 14713908Nathan 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.
Background: PubMed 25555366Perez-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.
BackgroundAlvear 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: PubMed 25378914Barros 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.
Individual participant dataSharing planned: No

Related trials for Asthma Chronic

Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rosa L Figueroa, PhD study director

Universidad de Concepcion

Carla Taramasco, PhD study director

Universidad de Valparaiso

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SIMAP in people with Asthma Chronic and Adherence, Medication, run by Universidad de Concepcion at 4 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control at 60 Days (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05609760, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.