NCT04105088

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

8.1 years

First QC Date

September 24, 2019

Last Update Submit

January 18, 2024

Conditions

Keywords

First NationsIndigenousEpidemiologyRisk FactorsCommunity-based Research

Outcome Measures

Primary Outcomes (3)

  • forced expiratory volume, 1st second in litres

    pre- and post-bronchodilator FEV1 to determine reversibility of airflow obstruction

    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 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 at study recruitment

Study Arms (2)

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.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We will recruit members of the participating First Nations communities, aged 30 years and older.

You may qualify if:

  • years and older
  • living in one of participating First Nations communities

You may not qualify if:

  • confusion, dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

13 individual First Nations in north-Central BC near Prince George, BC

Prince George, British Columbia, V2K5S3, Canada

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

dust samples from residences and community buildings

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pat G Camp, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Travis Holyk, PhD

    Carrier Sekani Family Services

    STUDY DIRECTOR

Central Study Contacts

Pat G Camp, PhD

CONTACT

Travis Holyk, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

February 13, 2018

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

No IPD is approved.

Locations