An interventional study of SIMAP and Usual Care in Asthma Chronic, Adherence, Medication and Primary Health Care, sponsored by Universidad de Concepcion. Terminated at 4 sites in Chile. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Universidad de Concepcion · Not applicable, Interventional, and Supportive care
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 22 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Universidad de Concepcion is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
Pictographic depiction of medical indications alongside standard communication of these recommendations.
Standard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well.
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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Inhaler Technique
Proper application of the inhaler technique.
Time frame: 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.
Time frame: 60 days
The first patient was recruited on August 1, 2022, and concluded prematurely, with the last patient recruited on December 20, 2022. This process was meant to be conducted for six months and had an early termination in the fifth month. Patients were recruited from 5 out of the six participating health centers. Each patient provided written consent through the signature of the informed consent form. The principal investigator and the director of the healthcare center then signed this consent.
| Milestone | Pictogram Group | Usual Care Group |
|---|---|---|
| Started | 10 | 12 |
| Completed | 9 | 11 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Median of ACT score | Pictogram Group | Usual Care Group |
|---|---|---|
| Disease Control at 60 Days | 22 (18 to 22) | 21 (18 to 23) |
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.
| Median of ACT score | Pictogram Group | Usual Care Group |
|---|---|---|
| Disease Control at 30 Days | 22 (18 to 23) | 23 (18 to 25) |
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.
| Median of ACT score | Pictogram Group | Usual Care Group |
|---|---|---|
| Disease Control at 7 Days | 19 (14 to 19) | 20 (15 to 22) |
Proper application of the inhaler technique.
| Participants | Pictogram Group | Usual Care Group |
|---|---|---|
| Shake the inhaler | 8 | 11 |
| Insert the inhaler chamber correctly. | 8 | 11 |
| Inhale inside the inhaler chamber. | 9 | 11 |
| Hold your breath for 10 seconds | 7 | 10 |
| Exhale inside the inhaler chamber. | 9 | 9 |
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.
| Participants | Pictogram Group | Usual Care Group |
|---|---|---|
| patient shakes the inhaler properly | 8 | 11 |
| The patient correctly attaches the air chamber to the inhaler | 8 | 11 |
| The patient inhales through the air chamber | 9 | 11 |
| The patient holds their breath for 10 seconds | 7 | 10 |
| The patient exhales into the air chamber | 9 | 9 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pictogram Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Usual Care Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
The pictogram group initially consisted of 10 patients who signed the informed consent. However, after signing, one of the patients withdrew from the study and did not answer to the instruments. Despite being initially assigned to the pictogram group, we lack details about the baseline characteristics of this patient. As a result, this individual was not included in the total count of patients in the pictogram group for the baseline analysis.
| Age, Continuous(years) | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| Median | 37 (25 to 56) | 40.5 (28 to 57) | 37 (27 to 57) |
| Sex: Female, Male(Participants) | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| Female | 6 | 9 | 15 |
| Male | 3 | 3 | 6 |
| Race and Ethnicity Not Collected(Participants) | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Citizenship(Participants) | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| Chilean | 7 | 10 | 17 |
| Colombian | 0 | 1 | 1 |
| Venezuelan | 2 | 1 | 3 |
| Educational level(Participants) | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| 8 years of education | 0 | 1 | 1 |
| 12 years of education | 4 | 6 | 10 |
| more than 12 years of education | 5 | 5 | 10 |
| Marital status(Participants) | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| single | 5 | 5 | 10 |
| married | 3 | 6 | 9 |
| divorced | 1 | 1 | 2 |
| Median of ACT score baseline(Median of ACT score) | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| Median | 14 (13 to 16) | 16 (14 to 20) | 16 (13 to 18) |
| Charlson index score(Median of the charlson score) | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| Median | 1 (1 to 2) | 1 (1 to 2) | 1 (1 to 2) |
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Universidad de Concepcion