Adherence, Medication, Asthma Chronic, Primary Health Care
Conditions
Keywords
Asthma Chronic, Adherence, Medication, Primary Health Care
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.
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.
Interventions
OTHERSIMAP
Pictographic depiction of medical indications alongside standard communication of these recommendations.
OTHERUsual Care
Standard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well.
Sponsors
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
Universidad de Concepcion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized clinical trial of parallel groups with triple masking amongst patients with a recent diagnosis of asthma (\<=15 days) in primary care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control at 60 Days | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inhaler Technique | 60 days | Proper application of the inhaler technique. |
| Patient Adherence to Inhaler Technique Steps at 60 Days | 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. |
Countries
Chile
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
SIMAP: Pictographic depiction of medical indications alongside standard communication of these recommendations. | 9 |
| 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.
Usual Care: Standard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well. | 12 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Pictogram Group | Usual Care Group | Total |
|---|---|---|---|
| Age, Continuous | 37 years | 40.5 years | 37 years |
| Charlson index score | 1 Median of the charlson score | 1 Median of the charlson score | 1 Median of the charlson score |
| Citizenship Chilean | 7 Participants | 10 Participants | 17 Participants |
| Citizenship Colombian | 0 Participants | 1 Participants | 1 Participants |
| Citizenship Venezuelan | 2 Participants | 1 Participants | 3 Participants |
| Educational level 12 years of education | 4 Participants | 6 Participants | 10 Participants |
| Educational level 8 years of education | 0 Participants | 1 Participants | 1 Participants |
| Educational level more than 12 years of education | 5 Participants | 5 Participants | 10 Participants |
| Marital status divorced | 1 Participants | 1 Participants | 2 Participants |
| Marital status married | 3 Participants | 6 Participants | 9 Participants |
| Marital status single | 5 Participants | 5 Participants | 10 Participants |
| Median of ACT score baseline | 14 Median of ACT score | 16 Median of ACT score | 16 Median of ACT score |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 12 |
| other Total, other adverse events | 0 / 9 | 0 / 12 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 |
Outcome results
Primary
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
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pictogram Group | Disease Control at 30 Days | 22 Median of ACT score |
| Usual Care Group | Disease Control at 30 Days | 23 Median of ACT score |
Primary
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
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pictogram Group | Disease Control at 60 Days | 22 Median of ACT score |
| Usual Care Group | Disease Control at 60 Days | 21 Median of ACT score |
Primary
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
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pictogram Group | Disease Control at 7 Days | 19 Median of ACT score |
| Usual Care Group | Disease Control at 7 Days | 20 Median of ACT score |
Secondary
Inhaler Technique
Proper application of the inhaler technique.
Time frame: 60 days
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pictogram Group | Inhaler Technique | Insert the inhaler chamber correctly. | 8 Participants |
| Pictogram Group | Inhaler Technique | Hold your breath for 10 seconds | 7 Participants |
| Pictogram Group | Inhaler Technique | Inhale inside the inhaler chamber. | 9 Participants |
| Pictogram Group | Inhaler Technique | Exhale inside the inhaler chamber. | 9 Participants |
| Pictogram Group | Inhaler Technique | Shake the inhaler | 8 Participants |
| Usual Care Group | Inhaler Technique | Exhale inside the inhaler chamber. | 9 Participants |
| Usual Care Group | Inhaler Technique | Shake the inhaler | 11 Participants |
| Usual Care Group | Inhaler Technique | Insert the inhaler chamber correctly. | 11 Participants |
| Usual Care Group | Inhaler Technique | Inhale inside the inhaler chamber. | 11 Participants |
| Usual Care Group | Inhaler Technique | Hold your breath for 10 seconds | 10 Participants |
Secondary
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
Population: We recruited 21 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pictogram Group | Patient Adherence to Inhaler Technique Steps at 60 Days | The patient correctly attaches the air chamber to the inhaler | 8 Participants |
| Pictogram Group | Patient Adherence to Inhaler Technique Steps at 60 Days | The patient holds their breath for 10 seconds | 7 Participants |
| Pictogram Group | Patient Adherence to Inhaler Technique Steps at 60 Days | The patient inhales through the air chamber | 9 Participants |
| Pictogram Group | Patient Adherence to Inhaler Technique Steps at 60 Days | The patient exhales into the air chamber | 9 Participants |
| Pictogram Group | Patient Adherence to Inhaler Technique Steps at 60 Days | patient shakes the inhaler properly | 8 Participants |
| Usual Care Group | Patient Adherence to Inhaler Technique Steps at 60 Days | The patient exhales into the air chamber | 9 Participants |
| Usual Care Group | Patient Adherence to Inhaler Technique Steps at 60 Days | patient shakes the inhaler properly | 11 Participants |
| Usual Care Group | Patient Adherence to Inhaler Technique Steps at 60 Days | The patient correctly attaches the air chamber to the inhaler | 11 Participants |
| Usual Care Group | Patient Adherence to Inhaler Technique Steps at 60 Days | The patient inhales through the air chamber | 11 Participants |
| Usual Care Group | Patient Adherence to Inhaler Technique Steps at 60 Days | The patient holds their breath for 10 seconds | 10 Participants |