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Active, Not Recruiting

NCT Number: NCT06562764

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Islamia University of Bahawalpur

Chak Four Hundred Fifty-four, Bahawalpur, 63100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Counselling by the Trained Pharmacist

Other

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

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.

Primary outcomes

  1. Proper/Improper use of inhaler

    Time frame: 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 outcomes

  1. Determine the adherence via a validated tool named the Medication Adherence Report Scale (MARS-5).

    Time frame: 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.

  2. Determine the Asthma Control in the asthmatic patients via ACT questionnaire.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Islamia University of Bahawalpur

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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