Clinical trial NCT07018583: A Study to Evaluate the Impact of a Pharmacist's Counseling and Self-Management Application Program on Asthma Management Outcomes Among Asthma Patients at a Midwest Chain Pharmacy in Iowa, United States
Official title: The Effectiveness of Pharmacist's Counseling and Self-Management Application Program on Asthma Management Outcomes Among Asthma Patients at a Midwest Chain Pharmacy in Iowa, United States
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma Patients
Keywords: Asthma, RCT, Pharmacist-led intervention, Asthma management , Asthma control, Medication adherence, Inhaler technique, Asthma awareness
Lead sponsor: Nakhon Ratchasim Rajabhat University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 84
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.

Participants are randomly assigned to one of two groups:

The intervention group receives pharmacist-led counseling integrated with a self-management mobile application program.

The control group receives usual care, including standard pharmacy services, without additional digital or structured counseling support.
Primary purpose: HEALTH_SERVICES_RESEARCH

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: Background \& Rationale:

Asthma is a significant noncommunicable disease that affects millions globally and is a major public health concern in the United States. Despite being manageable, asthma remains associated with preventable hospital visits, impaired quality of life, and substantial healthcare costs. In Iowa, the asthma prevalence is 9.1%, and emergency department visits due to asthma are worse than national averages.

Medication nonadherence is a persistent barrier to effective asthma management and is influenced by factors such as poor inhaler technique, lack of education, cost barriers, and weak provider-patient communication. Studies show that pharmacist-led interventions-focusing on education, counseling, self-management, and inhaler technique-significantly improve asthma control, medication adherence, and quality of life.

Chain pharmacies play a crucial role in providing accessible healthcare services, particularly through Medication Therapy Management (MTM) services. Pharmacists are well-positioned to identify asthma patients' needs, educate on proper medication use, and implement individualized action plans.

Previous randomized controlled trials (RCTs) in countries such as Lebanon, Italy, and Indonesia demonstrated that pharmacist interventions led to improved asthma outcomes. Systematic reviews confirm that interventions lasting three to six months are effective, with counseling, education, and self-management being the most impactful strategies.

This study builds on prior evidence by evaluating a pharmacist-led counseling and self-management application program within a Midwest chain pharmacy setting in Iowa.

Study Objectives:

The primary objective of this study is to evaluate the impact of a Pharmacist-Led Counseling and Self-Management Application Program on asthma management outcomes among patients receiving care at a chain pharmacy in Iowa, United States.

The research question:

What is the effectiveness of a pharmacist-led counseling and self-management application program on improving medication adherence, asthma control, inhaler technique, and asthma awareness among patients with asthma, as measured at 3 and 6 months?

Study Design:

This study is a 6-month, repeated-measures, parallel-group randomized controlled trial (RCT) designed to evaluate the effectiveness of a pharmacist-led counseling and self-management application program for asthma management.

The study consists of two arms/groups:

* Intervention Group: Participants receive a pharmacist-led counseling and self-management application program.
* Control Group: Participants receive usual care.

The participants:

Eligible participants will be screened according to predefined inclusion and exclusion criteria. Following eligibility confirmation, participants will be randomly assigned to either the intervention or control group using a computerized randomization method employing the RANDBETWEEN function in Microsoft Excel. A total of 42 participants will be allocated to each group. Randomization will be conducted under a single-blind design to minimize bias.

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.

Intervention Details:

The intervention consists of a Pharmacist-Led Counseling and Self-Management Program for asthma, delivered through both face-to-face counseling and a mobile application. The program integrates counseling principles and self-management theory to support asthma education, symptom monitoring, action planning, and self-evaluation.

The study employs a repeated-measures randomized controlled trial (RCT) design over two 3-month cycles, resulting in a total duration of 6 months. The intervention is 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 the mobile app and in-person counseling This six-step cycle would be repeated in months 4-6 to reinforce behavior change and improve long-term outcomes.

The "Don R.Ph. Asthma Management Application" is a digital tool designed to support and monitor the six-step pharmacist-led counseling and self-management process for asthma patients via mobile devices. It enables patients to participate in online counseling with pharmacists and access a range of self-care resources to enhance asthma management. Key features of the application include:

* Setting Your Goal! - Allows patients to set personalized asthma management goals.
* Understanding Asthma - Offers educational videos covering asthma basics and appropriate medication use.
* How to Use Asthma Inhalers - Provides demonstration videos on proper inhaler techniques.
* Healthy Lifestyle - Shares practical lifestyle tips to support asthma control.
* Asthma Self-Management \& Action Plan - Guides patients in developing and following an individualized asthma action plan.
* Automated Consultation - Delivers tailored, automated guidance and reminders based on patient input.
* Let Us Know - Provides immediate access to emergency pharmacist contact for urgent concerns.
* Assess Your Goal Achievement - Enables patients to track progress toward their management goals through self-assessment tools.

Control Group:

The control group received usual care, reflecting standard pharmacy practices. This includes comprehensive medication reviews, patient education on medication use during the initial visit or when a medication change occurs, and counseling provided upon patient request or as needed.

Primary and Secondary Outcomes:

The primary outcomes are medication adherence and asthma control. The secondary outcomes include inhaler technique skills and asthma awareness.

Study Duration:

The total duration of participation for each patient is six months, with repeated measurements conducted at the 3-month and 6-month time points.

Significance of the Research:

1. Apply the pharmacist-led counseling and self-management application program to support asthma patients who regularly visit Midwest chain pharmacies.
2. Promote the use of the application as a daily self-care tool for asthma patients to enhance medication adherence and disease management.
3. Provide a foundation for scaling and adapting the experimental program into a widely accessible public health application.

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.

Primary outcomes:
measure: Medication Adherence
timeFrame: Baseline, 3 months, and 6 months
measure: Asthma Control
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: