ICS Treatment Compliance of Asthma Patients

NCT02990117 | Completed DMC

• 1 other identifier: ESR-16-12138
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

The introduction of inhaled medication as the primary treatment for asthma has led to substantial improvements in asthma control \[1, 2\]. However, uncontrolled asthma is still common and represents a considerable burden to patients and society \[3, 4\]. An important reason for poor asthma control and consequently, increased healthcare expenditure is suboptimal adherence to the prescribed regimen \[5-7\]. Real-world market research study in hospitals across China reported that physicians perceived that only 23% of patients were fully compliant with their medication regime (77% non-adherent), compared to 55% in the European Union and 63% in the US \[AZ internal document\]. The physician reported rate of full adherence was lower than the patient-reported rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of physicians) when treating an asthma.\[8\] However There is some evidence on the drivers of patient behaviour around low adherence but more depth research is needed There is little evidence on variation of determinants of asthma inhaled treatment across different age of group Our research aims to address above data gap Mean while this research can guide the development of new module on Red Scarf patient education program.

Conditions

Asthma, Allergic

Outcome Measures

Primary Outcomes (1)

• MARS-A scale

  MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk factors (determinants explored from stage 1) measurements response from asthma patients

  Mar.2017-Dec,2017

Secondary Outcomes (1)

• MARS-A scale of group patients age in 18- 30, age in 31-45, age in 45-60, age above 60

  Mar.2017-Dec,2017

Study Arms (1)

Asthmatic patient

Asthma patients aged \>18 in out-patient clinic of the first affiliated hospital of Xi'an Jiaotong university from November 2016 to January 2018 were investigated. A two-stage study was applied which was non-assumptive deep dive qualitative scoping to investigate the determinants of poor compliance in stage 1 asthma patients, and developed new questionnaire for cross sectional survey in stage 2 to obtain more accurate information about the critical issues on asthma management.

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

Asthmatic patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stage 1: Asthmatic patients with in adequate asthma control (defined by GINA partly or un-control due to inhaled treatment compliance (physician judgement) Stage 2: Asthmatic patient who visit the outpatient clinic will be interviewed by investigator.

You may qualify if:

• Age ≥18 years old
• Living in the city same as the study site for a minimum period of two years
• Having China city residence medical insurance
• A history of at least one year of diagnosed asthma who should be on ICS or ICS/LABA inhalation treatment based on the criteria established by GINA.
• Patients On inhaled ICS or ICS/LABA treatment regard less of compliance level in the past 6 months
• Subjects who are willing to sign the informed consent.

You may not qualify if:

• Patients with active cardio or pulmonary disease such as bronchiectasis, COPD, cystic fibrosis, pulmonary tuberculosis, lung cancer, severe heart disease, etc.; other disorder such as HIV/AIDS, etc; or therapy that according to the physician could interfere with the aim of the study.
• Patients with mental or neurological diseases, or due to alcohol or other drug abuse, that may be incapable to understand and answer the question honestly, or unwilling to do so.
• Other conditions judged by investigator as unsuitable for this study

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• AstraZeneca: collaborator

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Manxiang Li, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Respiratory department

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 13, 2016
• Study Start: November 1, 2016
• Primary Completion: January 20, 2018
• Study Completion: January 20, 2018
• Last Updated: August 14, 2019

Record last verified: 2019-08