Influence of Inhaler Compliance on the Treatment of Asthma Patients

NCT ID: NCT06108908

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-14
• Study Completion Date: 2024-08-31

Brief Summary

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.

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.

Conditions

Pulmonary Disease; Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention Group

1. Patients (compliance rate <80%) received active contact to remind on regular use of medication.

2. The intervention is engaged in caring aspect behavior. None of regular asthma treatment is altered between groups.

Reminder

Intervention Type: BEHAVIORAL

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.

Reminder

Intervention Type: BEHAVIORAL

1\. The reminder is constrained in caring engagement that active engagements, e.g., phone call, or other instant messages, from study nurses to patients.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: collaborator

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Han-Pin KUO

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University, Taiwan, R.O.C.

Locations

Taipei Medical University, Taiwan, R.O.C.

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Han-Pin KUO

Role: CONTACT

hpk8828@gmail.com

+886975368066

Facility Contacts

Role: primary

tmujirb@gmail.com

+886-66202589 ext. 15313

Other Identifiers

N201905051

Identifier Type: -

Identifier Source: org_study_id