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

Not Applicable

Active, not recruiting

• Conditions: Asthma
• Interventions: Other: Counselling by the Trained Pharmacist; Other: Pictograms Cards and Counselling by the Trained Pharmacist

• Registration Number: NCT06562764
• Lead Sponsor: Islamia University of Bahawalpur

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.

Study Timeline

• Study Start: 2024-05-10
• Primary Completion: 2024-06-20
• Study First Submitted: 2024-07-27
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-17
• Last Update Submitted: 2024-08-17
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20
• Study Completion: 2024-08-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counselling by the Trained Pharmacist	Counselling by the Trained Pharmacist	The intervention group 1 is the set of subjects that receive the "counseling intervention" in a study.
Counselling and Pictograms	Pictograms Cards and Counselling by the Trained Pharmacist	Intervention group 2 consists of the subjects who receive the "counseling and pictogram intervention" in a study.

Primary Outcome Measures

Name	Time	Method
Proper/Improper use of inhaler	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Determine the adherence via a validated tool named the Medication Adherence Report Scale (MARS-5).	12 weeks	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.
Determine the Asthma Control in the asthmatic patients via ACT questionnaire.	12 weeks	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.

Trial Locations

Locations (1)

The Islamia University of Bahawalpur; 🇵🇰 Bahāwalpur, Bahawalpur, Pakistan