NCT05609760: SIMAP

Pictograms to Facilitate Comprehension of Medical Indications

Terminated NA Results posted Last updated 17 April 2025

What this trial tests

NA trial testing SIMAP in Asthma Chronic in 22 participants. Terminated before completion.

Timeline

1 August 2022

Primary endpoint
20 February 2023

20 February 2023

Quick facts

Lead sponsor	Universidad de Concepcion
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	22
Start date	1 August 2022
Primary completion	20 February 2023
Estimated completion	20 February 2023
Sites	4 locations across Chile

Drugs / interventions tested

• SIMAP
• Usual Care

Conditions studied

• Asthma Chronic — all drugs for Asthma Chronic →
• Adherence, Medication — all drugs for Adherence, Medication →
• Primary Health Care — all drugs for Primary Health Care →

Sponsor

Universidad de Concepcion — full company profile →

Who can join

Adults 18 to 65, any sex, with Asthma Chronic or Adherence, Medication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Disease Control at 60 Days Primary · 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.

Group	Value	95% CI
Pictogram Group	22	18 – 22
Usual Care Group	21	18 – 23

Disease Control at 30 Days Primary · 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.

Group	Value	95% CI
Pictogram Group	22	18 – 23
Usual Care Group	23	18 – 25

Disease Control at 7 Days Primary · 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.

Group	Value	95% CI
Pictogram Group	19	14 – 19
Usual Care Group	20	15 – 22

Inhaler Technique Secondary · 60 days

Proper application of the inhaler technique.

Shake the inhaler

Group	Value	95% CI
Pictogram Group	8
Usual Care Group	11

Insert the inhaler chamber correctly.

Group	Value	95% CI
Pictogram Group	8
Usual Care Group	11

Inhale inside the inhaler chamber.

Group	Value	95% CI
Pictogram Group	9
Usual Care Group	11

Hold your breath for 10 seconds

Group	Value	95% CI
Pictogram Group	7
Usual Care Group	10

Exhale inside the inhaler chamber.

Group	Value	95% CI
Pictogram Group	9
Usual Care Group	9

Patient Adherence to Inhaler Technique Steps at 60 Days Secondary · 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.

patient shakes the inhaler properly

Group	Value	95% CI
Pictogram Group	8
Usual Care Group	11

The patient correctly attaches the air chamber to the inhaler

Group	Value	95% CI
Pictogram Group	8
Usual Care Group	11

The patient inhales through the air chamber

Group	Value	95% CI
Pictogram Group	9
Usual Care Group	11

The patient holds their breath for 10 seconds

Group	Value	95% CI
Pictogram Group	7
Usual Care Group	10

The patient exhales into the air chamber

Group	Value	95% CI
Pictogram Group	9
Usual Care Group	9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.