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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Counselling by the Trained Pharmacist; Other: Pictograms Cards and Counselling by the Trained Pharmacist

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 Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Bahawalpur
    • Bahāwalpur, Bahawalpur, Pakistan, 63100
      • The Islamia University of Bahawalpur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controlled; The control group is the set of subjects that do not receive the intervention in a study.
Experimental: Counselling by the Trained Pharmacist; The intervention group 1 is the set of subjects that receive the "counseling intervention" in a study.	Other: Counselling by the Trained Pharmacist; The intervention group 1 is verbally counselled about the proper use of their inhaler devices.
Experimental: Counselling and Pictograms; Intervention group 2 consists of the subjects who receive the "counseling and pictogram intervention" in a study.	Other: Pictograms 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Islamia University of Bahawalpur
• Investigators: Study Director: Dr. Muhammad Atif, PhD, The Islamia University of Bahawalpur

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Actual): June 20, 2024
• Study Completion (Estimated): August 25, 2024

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 17, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Asthma; Inhaler; MDI; DPI; Pictograms; Pictogram cards
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 668/AS&R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD collected during the trial allowed by the research investigator, after deidentification.
• IPD Sharing Time Frame: Immediately after publication and no end date.
• IPD Sharing Access Criteria: Researchers who provide the methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No