Clinical trial NCT04105088: Bayis Ilh Tus - A Strong Breath: Prevalence and Contributors to COPD in First Nations Communities in British Columbia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: First Nations
Indigenous
Epidemiology
Risk Factors
Community-based Research
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Carrier Sekani Family Services
First posted: 2019-09-26
Enrollment: 325
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We will recruit members of the participating First Nations communities, aged 30 years and older.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 30 years and older
* living in one of participating First Nations communities

Exclusion Criteria:

* confusion, dementia

Primary outcomes:
measure: forced expiratory volume, 1st second in litres
timeFrame: measured at study recruitment
measure: forced vital capacity in litres
timeFrame: measured at study recruitment
measure: FEV1/FVC ratio
timeFrame: measured at study recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Prince George
country: Canada
facility: 13 individual First Nations in north-Central BC near Prince George, BC
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Pat G Camp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carrier Sekani Family Services
name: Travis Holyk, PhD
role: STUDY_DIRECTOR
References:
citation: 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.