Influence of Inhaler Compliance on the Treatment of Asthma Patients

NCT06108908 | Unknown

• 1 other identifier: N201905051
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Disease; Asthma

Outcome Measures

Primary Outcomes (2)

• compliance ratio

  Compliance Ratio: 1. 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. 2. 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: 1. the ACT is a patient self-administrated tool for identifying those with poorly controlled asthma; 2. the test includes 5 items to recall past 4-week symptoms and daily functioning; 3. The scores range from 5 as poorly controlled to 25 as completely controlled of asthma

  28 day

Study Arms (2)

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.

Behavioral: Reminder

Control

Patients were not informed regardless to their compliance rate.

Behavioral: Reminder

Interventions

Reminder 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; Intervention Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead
• Taipei Medical University: collaborator

Study Sites (1)

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

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Asthma

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Han-Pin KUO

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han-Pin KUO

CONTACT

+886975368066; hpk8828@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 31, 2023
• Study Start: August 14, 2019
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)