Pharmacist Counseling & Self-Management Program for Asthma Patients in a Midwest Chain Pharmacy, USA

Protocol of the Study This research employs a randomized controlled trial (RCT) methodology to evaluate the effectiveness of a pharmacist-led counseling and self-management application program for asthma management.

Study Design:

This is a 6-month, repeated-measures, parallel-group RCT designed to assess the intervention's impact on asthma outcomes. The study comprises two groups:

Intervention Group: Participants will receive a pharmacist-led counseling session combined with access to a self-management mobile application.

Control Group: Participants will receive usual care provided within the pharmacy setting.

Data Collection Process:

• Screening: Eligible participants will be identified based on predefined inclusion and exclusion criteria.
• Randomization and Blinding: After screening, eligible participants will be randomly assigned to either the intervention or control group in a single-blind manner.

Sample Size and Allocation:

• A total of 397 patients with asthma diagnosis codes will be initially screened for eligibility.
• Among these, 220 patients meeting the criteria will be assigned unique codes and recorded in Microsoft Excel.

Using simple randomization, 42 participants will be allocated to each group, maintaining a 1:1 ratio via computerized random number generation (using the RANDBETWEEN function in Excel) to minimize selection bias.

• Informed Consent: Participants will be provided with detailed study information and will give written informed consent prior to participation.

• Baseline Data Collection: Baseline demographic and clinical data will be gathered for all participants in both groups.

• Interventions:

• Intervention Group: Participants will undergo a structured pharmacist-led counseling and self-management program utilizing the "Don R.Ph. Asthma Management Application," a digital tool designed to support and monitor asthma management through six core steps over two 3-month cycles.
• Control Group: Participants will receive standard pharmacy care, including medication reviews, patient education, and counseling on medication use as needed or upon request.

• Follow-up and Duration: Follow-up data will be collected at three and six months during and after the intervention period.

The study spans six months, with the intervention structured into six steps:

Month 1:

Step 1: Initial Disclosure Step 2: Problem Assessment Step 3: Commitment to Action Step 4: Skill Enhancement

Month 2:

Step 5: Monitoring via mobile application

Month 3:

Step 6: Follow-up and evaluation via mobile app and in-person counseling

This cycle will be repeated in months 4-6 to reinforce behavioral changes and optimize long-term outcomes.

The "Don R.Ph. Asthma Management Application" is a digital platform to support and monitor the pharmacist-led counseling process through eight key features:

• Setting Your Goal! - Enables patients to establish personalized asthma management objectives.
• Understanding Asthma - Offers educational videos about asthma and proper medication use.
• How to Use Inhalers - Demonstrates correct inhaler techniques via videos.
• Healthy Lifestyle - Shares practical tips to promote overall health and asthma control.
• Asthma Self-Management & Action Plan - Guides patients in creating and following tailored action plans.
• Automated Consultation - Provides automated, personalized guidance and reminders
• Let Us Know - Offers quick access to emergency pharmacist contact for urgent concerns.
• Assess Your Goal Achievement - Allows patients to monitor their progress toward management goals through self-assessment tools.

Inclusion criteria

• Adult patients with asthma are 25 - 64 years of age.
• Have been receiving medications from the pharmacy of either Inhaled Corticosteroids (ICS) or a fixed combination of ICS with a long-acting beta-agonist (bronchodilator) and regular patronage of the pharmacy for the previous six months.
• Confirmed diagnosis from either the physician's diagnosis or the patient's self-report.
• No respiratory comorbidities (i.e., COPD or lung diseases).
• Uses a smartphone (IOS or Android).
• Ability to communicate with the pharmacist in English.
• Volunteer to participate in the program for the period.

Exclusion criteria

• The adult patient with asthma aged < 25 years or > 64 years old.
• The patient with one of the following - coronary heart disease, severe hypertension, severe heart failure, severe musculoskeletal disorder, mental health condition, dementia, chronic obstructive lung disease, or COVID-19.
• Participating in another "Pharmacy Counseling or Education Program."
• The patient does not have a smartphone (iOS or Android).
• The patient does not have sufficient comprehension or the ability to communicate effectively in English.
• The patient is unwilling or unable to participate in the entire program.