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To evaluate newly developed pictogram cards and their utility in improving inhaler techniques in asthmatic patients.
A prospective, open-label, randomized controlled clinical study. For this purpose, pictogram cards are designed for Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI).
The pictogram labels are designed and printed in colors with Urdu language and then attached to the inhaler devices as cards. The demographic, clinical, and medical data are collected from the patients and their medical files. Moreover, the different clinical measures are also evaluated in the recruited patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled | No Intervention | The control group is the set of subjects that do not receive the intervention in a study. | |
| Counselling by the Trained Pharmacist | Experimental | The intervention group 1 is the set of subjects that receive the "counseling intervention" in a study. |
|
| Counselling and Pictograms | Experimental | Intervention group 2 consists of the subjects who receive the "counseling and pictogram intervention" in a study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counselling by the Trained Pharmacist | Other | The intervention group 1 is verbally counselled about the proper use of their inhaler devices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proper/Improper use of inhaler | Determine the proper/improper use of inhaler via checklist. The dichotomous primary endpoint (Proper inhaler technique/ Improper Inhaler Technique). A participant is categorized as having proper inhaler technique if the score was 7/7 and improper technique if the score was < 7. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the adherence via a validated tool named the Medication Adherence Report Scale (MARS-5). | Adherence is the extent to which a person's behavior- taking medication, following a diet, and/or executing lifestyle changes- corresponds with the agreed recommendations from a healthcare provider. The adherence is measured via a validated tool named the Medication Adherence Report Scale (MARS-5). MARS-5 shows promise as a self-report tool for measuring patients' reports of their medication use across various illnesses. The score ranges from 5 to 25, where a higher MARS-5 score indicates higher self-reported adherence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Muhammad Atif, PhD | The Islamia University of Bahawalpur | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Islamia University of Bahawalpur | Chak Four Hundred Fifty-four | Bahawalpur | 63100 | Pakistan |
The IPD collected during the trial allowed by the research investigator, after deidentification.
Immediately after publication and no end date.
Researchers who provide the methodologically sound proposal.
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A parallel study is a type of clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
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An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants.
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| Pictograms Cards and Counselling by the Trained Pharmacist | Other | The investigator developed pictogram cards for the use of inhalers (MDI and DPI) and pictogram cards are attached to the inhalers of patients in the intervention group with counselling by the trained pharmacist. |
|
| 12 weeks |
| Determine the Asthma Control in the asthmatic patients via ACT questionnaire. | Asthma control is determined via ACT questionnaire. ACT scores range from 5-25 for the adult test and 0-27 for the child test. The higher the score, the better the asthma control. In both tests, a score of 20 or higher suggests your asthma is probably under control. | 12 weeks |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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