Pulmonary Disease, Chronic ObstructiveASBNCT04105088
Bayis Ilh Tus - A Strong Breath: Prevalence and Contributors to COPD in First Nations Communities in British Columbia
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of British Columbia at 1 site in Canada.
Trial summary
Background. First Nations peoples in Canada carry an increased respiratory health burden compared to non-First Nations. However, there is little accurate information of how many First Nations people have COPD, especially in remote and rural areas. Goal \& Aims of the Study. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 325 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2018to 31 Mar 2026
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit members of the participating First Nations communities, aged 30 years and older.
Who may be able to join
- 30 years and older
- living in one of participating First Nations communities
Who cannot join
- confusion, dementia
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
13 individual First Nations in north-Central BC near Prince George, BC
Prince George, British Columbia, V2K5S3
Travis Holyk, PhD, 250-962-5210, travis@csfs.org
Benna Rathburn, 250-962-5210, benna@csfs.org
About this study
Official title: Bayis Ilh Tus - A Strong Breath: Community-Based Research to Identify the Prevalence of and Contributors to Chronic Obstructive Pulmonary Disease in Remote and Rural First Nations Communities in British Columbia
Background. First Nations peoples in Canada carry an increased respiratory health burden compared to non-First Nations. However, there is little accurate information of how many First Nations people have COPD, especially in remote and rural areas.
Goal \& Aims of the Study. The goal of this study is to estimate the burden of COPD in remote and rural First Nations communities. This project is a partnership between the University of British Columbia (UBC), Carrier Sekani Family Services (CSFS), and 13 First Nations communities in northern BC.
Read more
Aim 1: Estimate the prevalence of COPD and the magnitude of underdiagnosis. Aim 2: Characterize the relationship between inhaled pollutants (from residential, occupational, and community/cultural sources) and: 1) symptoms; 2) airflow obstruction; and 3) health care utilization.
Methodology. The investigators will recruit adults from randomly-selected households in 13 First Nations communities in northern BC. Detailed measurements of lung function, symptoms, self-reported exposure to lung irritants, air quality, and healthcare use will be collected.
Expected Outcomes. This study will provide an accurate estimate of the prevalence of COPD and, using a culturally-relevant community-based research approach, will identify the contribution of risk factors to COPD in First Nations communities.
Read the detailed description
Background. First Nations peoples in Canada carry an increased respiratory health burden compared to non-First Nations. They are often exposed to high rates of indoor air pollution and cigarette smoke; and although there is a high use of acute health care services for chronic obstructive pulmonary disease (COPD), this disease is not "on the radar" in many First Nations communities. This may be because there is little accurate information of how many First Nations people have COPD, especially in remote and rural areas. The current estimates of prevalence of COPD in First Nations are based on self-report surveys, which are known to underestimate the true number threefold. Although it is well-known that cigarette smoking causes COPD, there has been less attention paid to the contribution of residential, historical/community/cultural, and occupational factors to the burden of COPD in First Nations people.
Goal \& Aims of the Study. The goal of this study is to estimate the burden of COPD in remote and rural First Nations communities. This project is a partnership between the University of British Columbia (UBC), Carrier Sekani Family Services (CSFS), and 13 First Nations communities in northern BC.
Aim 1: Estimate the prevalence of COPD and the magnitude of underdiagnosis. Aim 2: Characterize the relationship between inhaled pollutants (from residential, occupational, and community/cultural sources) and: 1) symptoms; 2) airflow obstruction; and; 3) health care utilization.
The Primary Outcome is the prevalence of COPD.
Methodology. The investigators will recruit adults from randomly-selected households in 13 First Nations communities in northern BC. The investigators will collect detailed measurements of lung function, symptoms, self-reported exposure to lung irritants, and healthcare use. The investigators will also collect indoor air quality measures from homes and community buildings. For Aim 1, the prevalence and underdiagnosis of COPD will be estimated by measuring lung function using post-bronchodilator spirometry and comparing the presence of airflow obstruction with the diagnosis of COPD in the electronic health record. For Aim 2, the investigators will explore the relationship between inhaled indoor air pollutants and 1) current cough, wheeze, and dyspnea; 2) airflow obstruction; and 3) respiratory-related primary care visits or hospitalization, adjusting for age, sex, and smoking history.
Expected Outcomes. This study will provide an accurate estimate of the prevalence of COPD and, using a culturally-relevant community-based research approach, will identify the contribution of risk factors to COPD in First Nations communities. The Primary Outcome is the prevalence of COPD.
Significance of this Project. This project is a novel partnership between UBC, CSFS and partner Nations to explore the prevalence and risk factors of COPD, using a Indigenous approach to health research. This study is unique in being able to address the risks of COPD in remote and rural First Nations communities, which will lead to further work to identify strategies to reduce these risks and improve lung health.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- First Nations, Indigenous, Epidemiology, Risk Factors, Community-based Research
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Randomly-Sampled | Adults aged 30+ living in one of the First Nations communities whose household was randomly-sampled. | |
| Walk-in Volunteers | Adults aged 30+ living in one of the First Nations communities who is a walk-in study volunteer, not randomly-sampled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced expiratory volume, 1st second in litres
pre- and post-bronchodilator FEV1 to determine reversibility of airflow obstruction
Measured: measured at study recruitment
forced vital capacity in litres
pre- and post-bronchodilator measures of vital capacity for use in the diagnosis of COPD
Measured: measured at study recruitment
FEV1/FVC ratio
pre- and post-bronchodilator measures of FEV1/FVC to confirm diagnosis of COPD (where the FEV1 to FVC <0.70)
Measured: measured at study recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start13 Feb 2018
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Cross-sectional
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Carrier Sekani Family Services
- Responsible party
- Principal investigator, Pat Camp, University of British Columbia
- Investigators
- Pat G Camp, PhD, Principal investigator, University of British ColumbiaTravis Holyk, PhD, Study director, Carrier Sekani Family Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105088
- Sponsor's protocol ID
- ASB-2018
- Acronym
- ASB
- Status last verified
- Jan 2024
- First submitted
- 24 Sep 2019
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD is approved.
Publications
Turner J, Holyk T, Bartlett K, Rathburn B, Karlen B, Ervin F, Wilson J, Camp PG. "Bayis Ilh Tus - a strong breath" a community-based research project to estimate the prevalence of chronic obstructive pulmonary disease in remote and rural first nations communities in Canada: research protocol. Int J Equity Health. 2020 Jul 24;19(1):123. doi: 10.1186/s12939-020-01240-1.
PubMed 32709235
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bayis Ilh Tus - A Strong Breath: Community-Based Research to Identify the Prevalence of and Contributors to Chronic Obstructive Pulmonary Disease in Remote and Rural First Nations Communities in British Columbia
- ClinicalTrials.gov ID
- NCT04105088
- Acronym / sponsor ID
- ASB / ASB-2018
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- First Nations, Indigenous, Epidemiology, Risk Factors, Community-based Research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Carrier Sekani Family Services
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Sep 2019 (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.
Background. First Nations peoples in Canada carry an increased respiratory health burden compared to non-First Nations. However, there is little accurate information of how many First Nations people have COPD, especially in remote and rural areas.
Goal \& Aims of the Study. The goal of this study is to estimate the burden of COPD in remote and rural First Nations communities. This project is a partnership between the University of British Columbia (UBC), Carrier Sekani Family Services (CSFS), and 13 First Nations communities in northern BC.
Aim 1: Estimate the prevalence of COPD and the magnitude of underdiagnosis. Aim 2: Characterize the relationship between inhaled pollutants (from residential, occupational, and community/cultural sources) and: 1) symptoms; 2) airflow obstruction; and 3) health care utilization.
Methodology. The investigators will recruit adults from randomly-selected households in 13 First Nations communities in northern BC. Detailed measurements of lung function, symptoms, self-reported exposure to lung irritants, air quality, and healthcare use will be collected.
Expected Outcomes. This study will provide an accurate estimate of the prevalence of COPD and, using a culturally-relevant community-based research approach, will identify the contribution of risk factors to COPD in First Nations communities.
Detailed description
Background. First Nations peoples in Canada carry an increased respiratory health burden compared to non-First Nations. They are often exposed to high rates of indoor air pollution and cigarette smoke; and although there is a high use of acute health care services for chronic obstructive pulmonary disease (COPD), this disease is not "on the radar" in many First Nations communities. This may be because there is little accurate information of how many First Nations people have COPD, especially in remote and rural areas. The current estimates of prevalence of COPD in First Nations are based on self-report surveys, which are known to underestimate the true number threefold. Although it is well-known that cigarette smoking causes COPD, there has been less attention paid to the contribution of residential, historical/community/cultural, and occupational factors to the burden of COPD in First Nations people.
Goal \& Aims of the Study. The goal of this study is to estimate the burden of COPD in remote and rural First Nations communities. This project is a partnership between the University of British Columbia (UBC), Carrier Sekani Family Services (CSFS), and 13 First Nations communities in northern BC.
Aim 1: Estimate the prevalence of COPD and the magnitude of underdiagnosis. Aim 2: Characterize the relationship between inhaled pollutants (from residential, occupational, and community/cultural sources) and: 1) symptoms; 2) airflow obstruction; and; 3) health care utilization.
The Primary Outcome is the prevalence of COPD.
Methodology. The investigators will recruit adults from randomly-selected households in 13 First Nations communities in northern BC. The investigators will collect detailed measurements of lung function, symptoms, self-reported exposure to lung irritants, and healthcare use. The investigators will also collect indoor air quality measures from homes and community buildings. For Aim 1, the prevalence and underdiagnosis of COPD will be estimated by measuring lung function using post-bronchodilator spirometry and comparing the presence of airflow obstruction with the diagnosis of COPD in the electronic health record. For Aim 2, the investigators will explore the relationship between inhaled indoor air pollutants and 1) current cough, wheeze, and dyspnea; 2) airflow obstruction; and 3) respiratory-related primary care visits or hospitalization, adjusting for age, sex, and smoking history.
Expected Outcomes. This study will provide an accurate estimate of the prevalence of COPD and, using a culturally-relevant community-based research approach, will identify the contribution of risk factors to COPD in First Nations communities. The Primary Outcome is the prevalence of COPD.
Significance of this Project. This project is a novel partnership between UBC, CSFS and partner Nations to explore the prevalence and risk factors of COPD, using a Indigenous approach to health research. This study is unique in being able to address the risks of COPD in remote and rural First Nations communities, which will lead to further work to identify strategies to reduce these risks and improve lung health.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomly-Sampled | – | –Adults aged 30+ living in one of the First Nations communities whose household was randomly-sampled. |
| Walk-in Volunteers | – | –Adults aged 30+ living in one of the First Nations communities who is a walk-in study volunteer, not randomly-sampled. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit members of the participating First Nations communities, aged 30 years and older.
Key inclusion criteria (2 listed)
- 30 years and older
- living in one of participating First Nations communities
Key exclusion criteria (1 listed)
- confusion, dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
forced expiratory volume, 1st second in litres
Time frame: measured at study recruitment
pre- and post-bronchodilator FEV1 to determine reversibility of airflow obstruction
forced vital capacity in litres
Time frame: measured at study recruitment
pre- and post-bronchodilator measures of vital capacity for use in the diagnosis of COPD
FEV1/FVC ratio
Time frame: measured at study recruitment
pre- and post-bronchodilator measures of FEV1/FVC to confirm diagnosis of COPD (where the FEV1 to FVC <0.70)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 32709235Turner J, Holyk T, Bartlett K, Rathburn B, Karlen B, Ervin F, Wilson J, Camp PG. "Bayis Ilh Tus - a strong breath" a community-based research project to estimate the prevalence of chronic obstructive pulmonary disease in remote and rural first nations communities in Canada: research protocol. Int J Equity Health. 2020 Jul 24;19(1):123. doi: 10.1186/s12939-020-01240-1.
- Individual participant dataSharing planned: No. No IPD is approved.
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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.
Pat G Camp, PhD principal investigator
University of British Columbia
Travis Holyk, PhD study director
Carrier Sekani Family Services
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 Pulmonary Disease, Chronic Obstructive, run by University of British Columbia 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pat G Camp, PhD (604-806-9144, pat.camp@hli.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced expiratory volume, 1st second in litres (time frame: measured at study recruitment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105088, which also lists 1 linked publication.
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 19 Jan 2024.