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Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients

Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients-Retrospective Observational Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03359122
Acronym
MARU
Enrollment
10067
Registered
2017-12-02
Start date
2018-06-07
Completion date
2018-08-20
Last updated
2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Brief summary

The aim of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.

Detailed description

Objectives: The primary objective of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history. Study design: This study is a retrospective database analysis using 2014-2016 Guangzhou City health insurance database. Data Source(s): Guangzhou city health insurance database will be used for this study. All outpatient and inpatient visits for one patient during 2014-2016 were available. Study Population: This study will include patients with a physician COPD diagnosis in Guangzhou city health insurance database during 2015 and with complete treatment data during 1 year before and 1 year after the index date. The rough sample size of the study population was 49,000. Outcome(s): 1. Indicators of COPD control: exacerbations; 2. Health resource utilization: annual number of inpatient days, inpatient visit number, emergency department (ED) visit number; 3. Costs: COPD exacerbation hospitalization expenditures, all-cause hospitalization expenditure. Statistical Analysis: Descriptive statistics will be used for all variables, as appropriate. Continuous variables will be summarized by the number of observations, mean, standard deviation, median, minimum, maximum, first quartile and third quartile. Categorical variables will be summarized by frequency counts and percentages at each category. Number of patients and number of missing for each variable will be summarized. Logistic regression will be used to estimate the risk of any hospitalization. Generalized Linear Models (GLMs) with a gamma distribution and log link will be used to approximate the highly right-skewed distribution of medical expenditure. For exploratory objectives, Propensity Score Matching (PSM) will be used to explore the association of medication class and health resource utilization if applicable. The interaction of medication class \* adherence or subgroup analysis (by medication class) will be considered when conducting the regression model.

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients diagnosed with COPD in 2015; 2. Patients had complete hospital visit data available during pre-index 1 year period and post 1 year follow-up; 3. Patients had at least one COPD exacerbation during 1 year prior to the index date; 4. Patients had at least 2 COPD maintenance medication claims during post index 1 year period, as 2 claims are recommended to calculate adherence.

Exclusion criteria

1. Inability to determine diagnoses from claims; 2. Individuals with other chronic respiratory conditions such as respiratory cancer, pulmonary fibrosis, asthma.

Design outcomes

Primary

MeasureTime frameDescription
Indicators of COPD control2015.01-2016.12Number of exacerbations
Health resource utilization2015.01-2016.12Annual number of inpatient days
Costs of inpatient treatment2015.01-2016.12Cost of COPD exacerbation inpatient treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026