Influence of Inhaler Compliance on the Treatment of Asthma Patients

The major goal of "Influence of Inhaler Compliance on the Treatment of Asthma Patients" is to explore compliance rate outcome in adult asthmatic patients (20-80 years old) with mild to moderate persistent asthma according to American Thoracic Society (ATS) definition and diagnosis. The major endpoints include:

1. To increase the adherence rate of treatment by reminder intervention with correctly monitor patients' adherence rate by Asthma Supportive Kits
2. Eventually achieve best asthma care and management.

All participants will use Asthma Supportive Kits for 24 weeks and return visit on week 5, 12, 24. Based on collected data, the study compares intervention and control group to see if active reminder intervention may effectively alter compliance rate, and corresponding outcomes, e.g., asthma control status, acute exacerbation events.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Pulmonary Disease
• Intervention / Treatment: Behavioral: Reminder

Detailed Description

1. Upon enrollment, the all patients will be educated and equipped with asthma supportive kits, which is a electronic device attaches to an MDI medicine.
2. The asthma supportive kit registers every puff taken when the patient uses his/her MDI. The records are monitored by study nurses and calculated compliance ratio on rolling basis.
3. By enrollment, the patient is RANDOMLY assigned to Intervention and Control group. For the Intervention group in each study phases, when the given compliance ratio drops below 80% (as monitored by asthma supportive kit), the study nurse will actively engage to remind on medicine taking. For the Control group, the compliance ratio is calculated but to active engagement is applied.
4. All the patients adheres with regular asthma treatment mechanism, regardless to group assigned.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Han-Pin KUO; Phone Number: +886975368066; Email: hpk8828@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University, Taiwan, R.O.C.
    • Principal Investigator: Han-Pin Kuo
    • Contact: Phone Number: 15313 +886-66202589; Email: tmujirb@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult asthmatic patients (20-80 years old) with mild to moderate persistent asthma according to ATS definition and diagnosis. Agree asthma is a common and potentially serious chronic disease.

Description

Inclusion Criteria:

1. Adult asthmatic patients (20-80 years old)
2. With mild to moderate persistent asthma according to ATS definition and diagnosis
3. Willing to use Budesonide+Formoterol.
4. Adequately use inhaler
5. Without evident intentional non-adherence
6. Agree asthma is a common and potentially serious chronic disease
7. Willing to sign Informed Consent Form

Exclusion Criteria:

1. Inadequately use inhaler
2. Disagree asthma is a common and potentially serious chronic disease
3. With uncontrolled systemic diseases, such as hypertension, heart failure, renal failure, de-compensated liver cirrhosis, etc.;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention Group; Patients (compliance rate <80%) received active contact to remind on regular use of medication.; The intervention is engaged in caring aspect behavior. None of regular asthma treatment is altered between groups.	Behavioral: Reminder; 1. The reminder is constrained in caring engagement that active engagements, e.g., phone call, or other instant messages, from study nurses to patients.
Control; Patients were not informed regardless to their compliance rate.	Behavioral: Reminder; 1. The reminder is constrained in caring engagement that active engagements, e.g., phone call, or other instant messages, from study nurses to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance ratio	Compliance Ratio: the Compliance Ratio evaluates the ratio of days which the patient is taking equal (or greater than) puffs of medicine as instructed by physician with the past 28-days.; the outcome ratio ranges from 0% (none of days is taking correct amount) to 100% (all past 28 days were taking correct amount).	28 day
Asthma Control Test Score	Asthma Control Test (ACT) Score: the ACT is a patient self-administrated tool for identifying those with poorly controlled asthma;; the test includes 5 items to recall past 4-week symptoms and daily functioning;; The scores range from 5 as poorly controlled to 25 as completely controlled of asthma	28 day

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Collaborators: Taipei Medical University
• Investigators: Principal Investigator: Han-Pin KUO, Taipei Medical University, Taiwan, R.O.C.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: N201905051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No