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

NCT06562764 | Active Not Recruiting DMC

• 1 other identifier: 668/AS&R
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Pictograms; MDI; DPI; Inhaler; Pictogram cards; Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  12 weeks

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

  12 weeks

Study Arms (3)

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.

Other: Counselling by the Trained Pharmacist

Counselling and Pictograms

EXPERIMENTAL

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

Interventions

Counselling by the Trained Pharmacist OTHER

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

Counselling by the Trained Pharmacist

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.

Counselling and Pictograms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Islamia University of Bahawalpur: lead

Study Sites (1)

The Islamia University of Bahawalpur

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

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Muhammad Atif, PhD

  The Islamia University of Bahawalpur

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Scholar

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 20, 2024
• Study Start: May 10, 2024
• Primary Completion: June 20, 2024
• Study Completion: August 25, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Immediately after publication and no end date.
• Access Criteria: Researchers who provide the methodologically sound proposal.

Locations

PA (1)