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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 84
- Primary Endpoint
- Medication Adherence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Ages
- 25 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
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."
Intervention: Pharmacist's Counseling and Self-Management Application Program (Behavioral)
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.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Inhaler technique skill(Baseline, 3 months, and 6 months)
- Asthma Awareness(Baseline, 3 months, 6 months)