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

NCT07018583 | Not Yet Recruiting DMC

• 1 other identifier: NRRU2025-001_DON
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma Patients

Keywords

Pharmacist-led-intervention; Asthma management; Asthma awareness

Outcome Measures

Primary Outcomes (2)

• Medication Adherence

  The Adherence to Asthma Medication Questionnaire (AAMQ-13) is a self-report scale developed by Nassar, Saini, Obeidat, and Basheti (2022). It consists of thirteen questions regarding the frequency of medication use, alterations, forgetfulness, and reasons for discontinuing medication over the past seven days. Each question is scored on a scale of 1 to 5, with options ranging from "Always, Often, Sometimes, Rarely, Never." The total score can range from 13 to 65. A low total score indicates a low level of medication adherence, while a high total score indicates a high level of medication adherence. However, the researcher conducted a statistical analysis to compare the mean medication adherence scores between the experimental and control groups after the intervention, and found a statistically significant difference.

  Baseline, 3 months, and 6 months

• Asthma Control

  The "Asthma Control Test (ACT)" is a self-administered questionnaire developed by Nathan (2004) to evaluate asthma control in patients. It consists of five questions that address asthma symptoms, medication use, and an overall assessment of asthma control over the past four weeks. Each question is scored on a scale of 1 to 5, with options ranging from "all of the time, most of the time, some of the time, a little of the time, " to " none of the time." The total score can range from 5 to 25, providing insight into the patient's level of asthma control. A low total score indicates a low level of asthma control, while a high total score indicates a high level of asthma control. However, the researcher conducted a statistical analysis to compare the mean asthma control scores between the experimental and control groups after the intervention, and found a statistically significant difference.

  Baseline, 3 months, and 6 months

Secondary Outcomes (2)

• Inhaler technique skill

  Baseline, 3 months, and 6 months

• Asthma Awareness

  Baseline, 3 months, 6 months

Study Arms (2)

Pharmacist-Led Counseling and Self-Management App Program

EXPERIMENTAL

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."

Behavioral: Pharmacist's Counseling and Self-Management Application Program

Comparator: Usual Care (Standard Pharmacy Services)

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

Pharmacist's Counseling and Self-Management Application Program 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.

Pharmacist-Led Counseling and Self-Management App Program

Usual Care 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.

Comparator: Usual Care (Standard Pharmacy Services)

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nakhon Ratchasim Rajabhat University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Outcome assessors and data analysts will be blinded to group assignments to minimize bias during data collection and statistical analysis. The researcher will not be blinded due to the nature of usual care.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: August 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1. Data will be made available beginning 6 months after publication of the primary study results, or 12 months after the completion of the trial, whichever occurs first. 2. The data will be available for at least 5 years following its release.
• Access Criteria: Qualified researchers affiliated with academic institutions, public health organizations, or non-profit entities.