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

June 23, 2025 updated by: Nakhon Ratchasim Rajabhat University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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."
Behavioral: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medication Adherence
Time Frame: Baseline, 3 months, and 6 months

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
Time Frame: Baseline, 3 months, and 6 months

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inhaler technique skill
Time Frame: Baseline, 3 months, and 6 months

"The Metered-Dose Inhaler technique; MDIs" NHLBI (2021) is used to assess inhaler technique skills. The assessment comprises ten items on how to use the inhaler, including removing and shaking the cap, breathing out, actuating the inhaler, inhaling, holding breath, and waiting before repeating the second puff. The assessment comprises "Competent technique (C) and "Improvement requires (I)," with a total score ranging from 0 to 12.

A low total score indicates a low level of inhaler technique skills, while a high total score indicates a high level of inhaler technique skills. However, the researcher conducted a statistical analysis to compare the mean inhaler technique skills scores between the experimental and control groups after the intervention, and found a statistically significant difference.
Baseline, 3 months, and 6 months
Asthma Awareness
Time Frame: Baseline, 3 months, 6 months

The self-report on asthma awareness, developed by the researcher, includes perceptions of asthma severity, lifestyle factors, environmental management, prevention strategies, identification of triggers and early symptoms, medication adherence, correct inhaler use, readiness to follow an asthma action plan, and the importance of follow-up care. The total number of questions on asthma awareness consists of fifteen items. Each question is scored on a scale of 1 to 5 with options ranging from "Strongly disagree, Disagree, Neutral, Agree, and Strongly disagree." The total score can range from 15 to 75.

A low total score indicates a low level of asthma awareness, while a high total score indicates a high level of asthma awareness. However, the researcher conducted a statistical analysis to compare the mean asthma awareness scores between the experimental and control groups after the intervention, and found a statistically significant difference.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nakhon Ratchasim Rajabhat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRRU2025-001_DON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

  1. De-identified individual participant data related to the study's primary and secondary outcomes, including data on medication adherence, asthma control scores, inhaler technique performance, and asthma awareness assessments.
  2. Study protocol, statistical analysis plan, and informed consent form (de-identified and redacted as appropriate).

IPD Sharing 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.

IPD Sharing Access Criteria

Qualified researchers affiliated with academic institutions, public health organizations, or non-profit entities.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma Patients

Clinical Trials on Pharmacist's Counseling and Self-Management Application Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings