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

NCT ID: NCT07018583

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-05-31

Brief Summary

This clinical trial aims to evaluate the effectiveness of a pharmacist-led counseling and self-management application program on improving asthma management outcomes among adult patients with asthma receiving care at a Midwest chain pharmacy in Iowa, United States.

The study investigates whether integrating the pharmacist counseling with self-management theory can enhance patients' medication adherence, asthma control, inhaler technique, and overall asthma awareness. These outcomes will be assessed at both 3 and 6 months after enrollment.

Participants will be randomly assigned to one of two arms. The intervention group, which will receive a comprehensive pharmacist-led counseling program supported by a mobile application ("Don R.Ph Application").

The control group, which will receive standard pharmacy care as per usual practice.

Detailed Description

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:

1. Screening: Eligible participants will be identified based on predefined inclusion and exclusion criteria.

2. 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.

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

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

6. 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.

7. 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:

1. Setting Your Goal! - Enables patients to establish personalized asthma management objectives.

2. Understanding Asthma - Offers educational videos about asthma and proper medication use.

3. How to Use Inhalers - Demonstrates correct inhaler techniques via videos.

4. Healthy Lifestyle - Shares practical tips to promote overall health and asthma control.

5. Asthma Self-Management & Action Plan - Guides patients in creating and following tailored action plans.

6. Automated Consultation - Provides automated, personalized guidance and reminders

7. Let Us Know - Offers quick access to emergency pharmacist contact for urgent concerns.

8. Assess Your Goal Achievement - Allows patients to monitor their progress toward management goals through self-assessment tools.

Conditions

Asthma Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Pharmacist-Led Counseling and Self-Management App Program

Participants in this arm will receive a structured asthma management intervention consisting of pharmacist-led counseling and access to the "Don R.Ph. Asthma Management Application."

Group Type: EXPERIMENTAL

Pharmacist's Counseling and Self-Management Application Program

Intervention Type: BEHAVIORAL

This interventional study is structured around established counseling principles and self-management theory, consisting of six sequential stages: Initial Disclosure, Problem Assessment, Commitment to Action, Skill Enhancement, Monitoring, and Follow-up and Evaluation. These stages are delivered through both in-person pharmacist counseling and a dedicated mobile application. The intervention follows a repeated-measures design, with assessments conducted at 3 and 6 months after enrollment.

Comparator: Usual Care (Standard Pharmacy Services)

The participants will recieve standard pharmacy practices such as medication reviews, patient education during the initial visit or when medication changes occur, and counseling upon patient request. No additional structured counseling or self-management tools are provided.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Usual care or Standard pharmacy practices such as medication reviews, patient education during the initial visit or when medication changes occur, and counseling upon patient request. No additional structured counseling or self-management tools are provided.

Interventions

Pharmacist's Counseling and Self-Management Application Program

This interventional study is structured around established counseling principles and self-management theory, consisting of six sequential stages: Initial Disclosure, Problem Assessment, Commitment to Action, Skill Enhancement, Monitoring, and Follow-up and Evaluation. These stages are delivered through both in-person pharmacist counseling and a dedicated mobile application. The intervention follows a repeated-measures design, with assessments conducted at 3 and 6 months after enrollment.

Intervention Type: BEHAVIORAL

Usual Care

Usual care or Standard pharmacy practices such as medication reviews, patient education during the initial visit or when medication changes occur, and counseling upon patient request. No additional structured counseling or self-management tools are provided.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Adult patients with asthma are 25 - 64 years of age.

2. 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.

3. Confirmed diagnosis from either the physician's diagnosis or the patient's self-report.

4. No respiratory comorbidities (i.e., COPD or lung diseases).

5. Uses a smartphone (IOS or Android).

6. Ability to communicate with the pharmacist in English.

7. Volunteer to participate in the program for the period.

Exclusion Criteria

1. The adult patient with asthma aged < 25 years or > 64 years old.

2. 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.

3. Participating in another "Pharmacy Counseling or Education Program."

4. The patient does not have a smartphone (iOS or Android).

5. The patient does not have sufficient comprehension or the ability to communicate effectively in English.

6. The patient is unwilling or unable to participate in the entire program.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nakhon Ratchasim Rajabhat University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NRRU2025-001_DON

Identifier Type: -

Identifier Source: org_study_id