Asthma Control Through Telemedicine (PLET-I)

The Pharmacist Led Educational Interventions Through Telemedicine to Improve Asthma Control: a Randomized Control Trial

The purpose of this research study is to evaluate the impact of pharmacist led educational interventions on Asthmatic patients, and also determine their medication adherence.

Pharmacist's intervention aims to answer:

1. How a pharmacist intervention program impact medication adherence in persistent asthma?
2. To assess how pharmacist led educational intervention like patients' counseling and medication reminders through Telemedicine have an impact on patient's asthma control?
3. Which mode of communication (Verbal instructions, videos and pamphlets) for the patient counselling is most beneficial for the patients in asthma control.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthmatic Patients
• Intervention / Treatment: Other: Educational

Detailed Description

This is a randomized, pharmacist-led, two-group, longitudinal descriptive interventional study performed through in person (Public and private hospitals) and telecommunication (WhatsApp, network calls and messaging). The investigator will use snowball method to approach patients through telecommunication. Recruited patients will be randomly divided into two groups: the Control and the experimental group. The Control Group will not receive any intervention, and experimental group will receive special counseling about persistent asthma, it's medications and medical devices, their appropriate use, and side effects. Using Telemedicine as message and call reminders to increase medication adherence and improve their asthmatic condition. The intervention will be conducted for one month on the experimental group according to the recruitment date and time of the patients.

Pre-validated questionnaires will be used for the assessment

1. The adherence to asthma medication questionnaire (AAMQ-13).
2. Asthma Control test TM (ACT).

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MUhammad Abubakar, PhD; Phone Number: +923237166544; Email: mabubakar.pharmacist@gmail.com
• Study Contact Backup: Name: Matti Ullah, PhD; Phone Number: 5119 0092-51-8840000; Email: mattiullah@hamdard.edu.ph

Study Locations

• Pakistan
  • Punjab
    • Islamabad, Punjab, Pakistan, 44000
      • Hamdard University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age above 11 years.
• Persistent Asthma Patient.
• Patients taking medications and inhaler.
• Patient who will consent for the study.
• Patient with basic telecommunication facility.
• Patient who responded to messages and calls.

Exclusion Criteria:

• Patients who will refuse to participate in study will not be included.
• Irresponsive patients to messages and calls

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Experimental: Study group; intervention included the usual counselling by pharmacist e.g. Patients Education regarding Medications; Pharmacist counseling patients regarding their disease and severity; Pharmacist counseling (5- to 10-minute sessions) on the proper and safe use of medication.; Pharmacist counseling patients regarding the importance of their therapy (treatment), non-pharmacological treatment like diet and exercises. pharmacist counselling regarding the preventive measures that prevent patient from triggers that can initiate asthmatic attacks.	Other: Educational; intervention included the usual counselling by pharmacist e.g. Patients Education regarding Medications; Pharmacist counseling patients regarding their disease and severity; Pharmacist counseling (5- to 10-minute sessions) on the proper and safe use of medication.; Pharmacist counseling patients regarding the importance of their therapy (treatment), non-pharmacological treatment like diet and exercises. pharmacist counselling regarding the preventive measures that prevent patient from triggers that can initiate asthmatic attacks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Score	Patient health related outcomes that is level of asthma control is measured by pre-validated tool Asthma Control test TM (ACT). The Asthma Control Test™ assess responsiveness to changes in asthma control over time. The tool has 5 questions with each having options with scores 1,2,3,4, and 5. A SCORE OF 19 OR LESS might be a warning of the need for further evaluation to determine whether adjustments to asthma treatment regimens or other measures are required to improve asthma control. If score is 15 or less, asthma may be poorly controlled or not controlled at all.	1 month
Patients Medication Adherence Score	The primary aim of this study will be to evaluate the effectiveness/impact of a pharmacist educational intervention on medication adherence in Asthmatic patients. Adherence will be measured using the adherence to asthma medication questionnaire (AAMQ-13 The AAMQ-13 is a reliable and valid questionnaire with several desirable characteristics as it has a high internal validity, good criterion validity, and strong construct validity. The AAMQ-13 is a suitable questionnaire that can identify non-adherent patients and reveal the reasons behind their non-adherence (intentional or unintentional non-adherence). Each question has Always, Often, sometimes, rarely and never response with scores allotted as 1,2,3,4 and 5 respectively, Score interpretation is as follows for the given tool Poor adherence Score= 13-29 Moderate adherence Score= 30-47 Excellent adherence= 48-65	1 month

Collaborators and Investigators

• Sponsor: Hamdard University

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2025
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): May 20, 2025

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Asthma; pharmacist
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: ABJan012025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participant's identity is to be kept strictly confidential as per consent form that will be prepared for the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No