Influence of Inhaler Compliance on the Treatment of Asthma Patients

Asthma Clinical Trial

Official title:

Influence of Inhaler Compliance on the Treatment of Asthma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108908
• Other study ID #: N201905051
• Status: Recruiting
• Start date: August 14, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: Taipei Medical University Hospital
• Contact: Han-Pin KUO
• Phone: +886975368066
• Email: hpk8828[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.;

Related Conditions & MeSH terms

• Asthma
• Pulmonary Disease

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University, Taiwan, R.O.C.	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University Hospital	Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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