Influence of Inhaler Compliance on the Treatment of Asthma Patients

Taipei Medical University

Status: Enrolling

Conditions: Asthma; Pulmonary Disease

Treatments: Behavioral: Reminder

Study type: Observational

Funder types: Other

Identifiers

NCT06108908

N201905051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.;

Trial design

150 participants in 2 patient groups

Intervention Group

Description:

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.

Treatment:

Behavioral: Reminder

Control

Description:

Patients were not informed regardless to their compliance rate.

Treatment:

Behavioral: Reminder