Chronic Obstructive Pulmonary Disease (COPDNCT04966637
Identifying Early Chronic Obstructive Pulmonary Disease (COPD) Using Health Administrative Data
An observational study of Chronic Obstructive Pulmonary Disease (COPD, run by University of Alberta at 1 site in Canada.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) affects the airways that causes shortness of breath, cough. COPD gets worse over time, and often leads to emergency department visits, hospital visits, frequent doctor appointments and medications. This means COPD is expensive, and severely impacts patient quality of life. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD
- What is being tested?
- COPD cohort
- How many people
- 54,028 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes all individuals in the province of Alberta that meet the inclusion criteria, and have accessed the provincial health care system during the study period. All individuals that have an incident case of COPD within the 3 year time period for study inclusion that reside in Alberta will have their data included in the study. Based on our pre-existing knowledge of the administrative data available, we would expect over 50,000 individual patients in the cohort. Given our health care is provided at a provincial level, we would expect this would capture all individuals in the province that had their incident diagnosis of COPD in the time period. The exception may be individuals that were diagnosed with COPD while out of province.
Who may be able to join
- Must have had at least one visit to a physician with a diagnosis of COPD (by ICD-9(-CM) 491-492, 496) or one hospital separation with a diagnosis of COPD (ICD-10-CA J41-44).
- Incidence criteria included 5 year washout period in which they were not in Alberta, Canada but did not have any diagnosis of COPD
- Individuals that meet this criteria with a new diagnosis in the last 3 years will be included in the cohort, thus individuals with their 'incident' diagnosis of COPD in the last three years will be included (01-APR-2016 to 31-MAR-2017, 01-APR-2017 to 31-MAR-2018; 01-APR-2018 to 31-MAR-2019)
Who cannot join
- Individuals that were diagnosed with COPD prior to or after the enrollment period.
- Individuals that did not live in Alberta (with access to Alberta health care) during the five year washout period
Trial locations and contacts
1 site in 1 country.
About this study
Chronic Obstructive Pulmonary Disease (COPD) affects the airways that causes shortness of breath, cough. COPD gets worse over time, and often leads to emergency department visits, hospital visits, frequent doctor appointments and medications. This means COPD is expensive, and severely impacts patient quality of life. Unfortunately, patients are often not properly diagnosed until their disease is fairly advanced. We know a lot about the health care use of people with COPD once they have been diagnosed, but we do not know much about what happens to them leading up to their diagnosis. Through this project we want to better understand the time period prior to COPD diagnosis, so that we can learn more about what happens to people before they are diagnosed.
This project will use health data to find out if we can identify trends in health care use by individuals newly diagnosed with COPD. We will identify people that have COPD based on health records, and look back to find out about their health care use prior to their diagnosis. We will look at data related to doctors' visits, emergency department visits, hospital stays and medications. We want to use these markers to better understand what happens to people before they are diagnosed, and to find out if we can identify risk factors for a COPD diagnosis. We hope by doing this research we can better identify people at risk for COPD and ensure that they receive treatment early, which may improve their health outcomes.
Read the detailed description
Study Objectives
- Identifying a cohort of individuals with a new onset of COPD in the between April 1, 2016 and March 31, 2019.
- To determine factors associated with a new diagnosis of COPD through using traditional mixed-model regression.
- To evaluate whether information collected within administrative data can be used to create a prediction model for a COPD diagnosis.
- To determine whether machine learning methodology improves the prediction of a new COPD diagnosis from administrative data.
Measures:
- The cohort of individuals with COPD in Alberta has already been defined, and this data exists within the Alberta Health Services, Respiratory Health Strategic Clinical Network (RHSCN) dataset. It will be used to further identify individuals with a new diagnosis of COPD within the three year study time period.
- In order to conduct this study, a variety of data sets will be used including:
- Inpatient Discharge Abstract Database;
- Practitioner Claims Database;
- Provincial Registry Database;
- Population Health Database and
- Pharmaceutical information Network
Project Hypothesis We anticipate individuals with a diagnosis of COPD in the last three years will have identifiable markers associated with lung disease in the five years prior to their diagnosis. These markers may include: diagnosis of acute respiratory disease (such as pneumonia, bronchitis, upper respiratory infections), increased health care utilization, and the use of medications such as antibiotics.
The project plan will address the specific project goals as follows:
- Identifying a cohort of individuals with a new onset of COPD from April 1, 2016 to March 30, 2019. Through the RHSCN, a cohort of individuals with COPD has been identified of over 200,000 individuals with COPD in Alberta. This cohort will be refined to identify only those individuals that have been diagnosed within the specified time period. This time period was chosen due to data availability. Given our most recent data, we know that approximate 19,000 individuals have been diagnosed with COPD per year, over the last five years. Thus we can approximate that our dataset will include approximately 55,000 individuals with COPD diagnosed in a three year time period.
- Retrospectively review the pattern of health care utilization for individuals with a new diagnosis of COPD in the five years prior to their diagnosis. The health care utilization (ED visits, hospitalization visits, physician visits) for each case in the cohort for the previous five years will be identified.
- Explore the medication use for individuals with COPD for five years prior to their diagnosis. Lastly, the medication use for each case identified in the cohort during the time period five years prior to their diagnosis will be explored. The Pharmaceutical Information Network (PIN) database will be used to identify all medications (both respiratory and non-respiratory) for individuals in the cohort to assess medication use prior to diagnosis.
- Working with the machine learning provider (AltaML) we will additionally conduct a machine learning based analysis to further explore this data set regarding the same variables.
- Being tested
- COPD cohort
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD cohortOther
as this a retrospective descriptive study no intervention will be administered to study participants
| Study group | Role | What they receive |
|---|---|---|
| Individuals with COPD | This retrospective annual analysis will use the following validated case definition to identify a cohort of individuals with COPD: an individual aged 35 years and older having at least one visit to a physician with a diagnosis of COPD (by ICD-9(-CM) 491-492, 496) or one hospital separation with a diagnosis of COPD (ICD-10-CA J41-44) between April 1, 2016 and March 31, 2019.
This is a retrospective descriptive study with administrative data and no intervention will be administered to the cohort Receives: Other: COPD cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine factors associated with a new diagnosis of COPD
Health care utilization (physician visits, hospitalizations, emergency department visits, dispensed medication for the cohort of patients five year prior to their diagnosis will be evaluated
Measured: each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)
Secondary outcomes (2)
prediction model for COPD
Health care utilization (physician visits, hospitalizations, emergency department visits, dispensed medication for the cohort of patients five year prior to their diagnosis will be evaluated
Measured: each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)
machine learning prediction model for COPD
Health care utilization (physician visits, hospitalizations, emergency department visits, dispensed medication for the cohort of patients five year prior to their diagnosis will be evaluated using machine learning
Measured: each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jun 2021
- Primary completion30 Oct 2022
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPDStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Michael Stickland, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966637
- Sponsor's protocol ID
- Pro00097014
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2021
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Early Chronic Obstructive Pulmonary Disease (COPD) Using Health Administrative Data
- ClinicalTrials.gov ID
- NCT04966637
- Acronym / sponsor ID
- Pro00097014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54,028 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Alberta Health services
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Obstructive Pulmonary Disease (COPD) affects the airways that causes shortness of breath, cough. COPD gets worse over time, and often leads to emergency department visits, hospital visits, frequent doctor appointments and medications. This means COPD is expensive, and severely impacts patient quality of life. Unfortunately, patients are often not properly diagnosed until their disease is fairly advanced. We know a lot about the health care use of people with COPD once they have been diagnosed, but we do not know much about what happens to them leading up to their diagnosis. Through this project we want to better understand the time period prior to COPD diagnosis, so that we can learn more about what happens to people before they are diagnosed.
This project will use health data to find out if we can identify trends in health care use by individuals newly diagnosed with COPD. We will identify people that have COPD based on health records, and look back to find out about their health care use prior to their diagnosis. We will look at data related to doctors' visits, emergency department visits, hospital stays and medications. We want to use these markers to better understand what happens to people before they are diagnosed, and to find out if we can identify risk factors for a COPD diagnosis. We hope by doing this research we can better identify people at risk for COPD and ensure that they receive treatment early, which may improve their health outcomes.
Detailed description
Study Objectives
- Identifying a cohort of individuals with a new onset of COPD in the between April 1, 2016 and March 31, 2019.
- To determine factors associated with a new diagnosis of COPD through using traditional mixed-model regression.
- To evaluate whether information collected within administrative data can be used to create a prediction model for a COPD diagnosis.
- To determine whether machine learning methodology improves the prediction of a new COPD diagnosis from administrative data.
Measures:
- The cohort of individuals with COPD in Alberta has already been defined, and this data exists within the Alberta Health Services, Respiratory Health Strategic Clinical Network (RHSCN) dataset. It will be used to further identify individuals with a new diagnosis of COPD within the three year study time period.
- In order to conduct this study, a variety of data sets will be used including:
- Inpatient Discharge Abstract Database;
- Practitioner Claims Database;
- Provincial Registry Database;
- Population Health Database and
- Pharmaceutical information Network
Project Hypothesis We anticipate individuals with a diagnosis of COPD in the last three years will have identifiable markers associated with lung disease in the five years prior to their diagnosis. These markers may include: diagnosis of acute respiratory disease (such as pneumonia, bronchitis, upper respiratory infections), increased health care utilization, and the use of medications such as antibiotics.
The project plan will address the specific project goals as follows:
- Identifying a cohort of individuals with a new onset of COPD from April 1, 2016 to March 30, 2019. Through the RHSCN, a cohort of individuals with COPD has been identified of over 200,000 individuals with COPD in Alberta. This cohort will be refined to identify only those individuals that have been diagnosed within the specified time period. This time period was chosen due to data availability. Given our most recent data, we know that approximate 19,000 individuals have been diagnosed with COPD per year, over the last five years. Thus we can approximate that our dataset will include approximately 55,000 individuals with COPD diagnosed in a three year time period.
- Retrospectively review the pattern of health care utilization for individuals with a new diagnosis of COPD in the five years prior to their diagnosis. The health care utilization (ED visits, hospitalization visits, physician visits) for each case in the cohort for the previous five years will be identified.
- Explore the medication use for individuals with COPD for five years prior to their diagnosis. Lastly, the medication use for each case identified in the cohort during the time period five years prior to their diagnosis will be explored. The Pharmaceutical Information Network (PIN) database will be used to identify all medications (both respiratory and non-respiratory) for individuals in the cohort to assess medication use prior to diagnosis.
- Working with the machine learning provider (AltaML) we will additionally conduct a machine learning based analysis to further explore this data set regarding the same variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with COPD | – | Other: COPD cohortThis retrospective annual analysis will use the following validated case definition to identify a cohort of individuals with COPD: an individual aged 35 years and older having at least one visit to a physician with a diagnosis of COPD (by ICD-9(-CM) 491-492, 496) or one hospital separation with a diagnosis of COPD (ICD-10-CA J41-44) between April 1, 2016 and March 31, 2019. This is a retrospective descriptive study with administrative data and no intervention will be administered to the cohort |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes all individuals in the province of Alberta that meet the inclusion criteria, and have accessed the provincial health care system during the study period. All individuals that have an incident case of COPD within the 3 year time period for study inclusion that reside in Alberta will have their data included in the study. Based on our pre-existing knowledge of the administrative data available, we would expect over 50,000 individual patients in the cohort. Given our health care is provided at a provincial level, we would expect this would capture all individuals in the province that had their incident diagnosis of COPD in the time period. The exception may be individuals that were diagnosed with COPD while out of province.
Key inclusion criteria (3 listed)
- Must have had at least one visit to a physician with a diagnosis of COPD (by ICD-9(-CM) 491-492, 496) or one hospital separation with a diagnosis of COPD (ICD-10-CA J41-44).
- Incidence criteria included 5 year washout period in which they were not in Alberta, Canada but did not have any diagnosis of COPD
- Individuals that meet this criteria with a new diagnosis in the last 3 years will be included in the cohort, thus individuals with their 'incident' diagnosis of COPD in the last three years will be included (01-APR-2016 to 31-MAR-2017, 01-APR-2017 to 31-MAR-2018; 01-APR-2018 to 31-MAR-2019)
Key exclusion criteria (2 listed)
- Individuals that were diagnosed with COPD prior to or after the enrollment period.
- Individuals that did not live in Alberta (with access to Alberta health care) during the five year washout period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD cohortas this a retrospective descriptive study no intervention will be administered to study participants | Other | Individuals with COPD |
Primary outcome
determine factors associated with a new diagnosis of COPD
Time frame: each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)
Health care utilization (physician visits, hospitalizations, emergency department visits, dispensed medication for the cohort of patients five year prior to their diagnosis will be evaluated
2 secondary outcomes
prediction model for COPD
Time frame: each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)
machine learning prediction model for COPD
Time frame: each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stickland, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine factors associated with a new diagnosis of COPD (time frame: each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.