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To Evaluate Newly Developed Pictogram Cards and Their Utility in Improving Inhaler Techniques in Asthmatic Patients

Role of Pharmaceutical Pictograms in Disease Management: A Mix Method Study of Various Stakeholders in Pakistan

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06562764
Enrollment
320
Registered
2024-08-20
Start date
2024-05-10
Completion date
2024-08-25
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Pictograms, MDI, DPI, Inhaler, Pictogram cards, Asthma

Brief summary

To evaluate newly developed pictogram cards and their utility in improving inhaler techniques in asthmatic patients.

Detailed description

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.

Interventions

OTHERCounselling by the Trained Pharmacist

The intervention group 1 is verbally counselled about the proper use of their inhaler devices.

OTHERPictograms Cards and Counselling by the Trained Pharmacist

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.

Sponsors

Islamia University of Bahawalpur
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Asthmatic Patients, should take inhalers regularly for at least 3 months and come personally for re-fill.

Exclusion criteria

* Coexistence of other chronic respiratory conditions. * Those who were difficult to communicate.

Design outcomes

Primary

MeasureTime frameDescription
Proper/Improper use of inhaler12 weeksDetermine 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.

Secondary

MeasureTime frameDescription
Determine the adherence via a validated tool named the Medication Adherence Report Scale (MARS-5).12 weeksAdherence 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.
Determine the Asthma Control in the asthmatic patients via ACT questionnaire.12 weeksAsthma 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026