Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life. The investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals. The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in a randomized, controlled clinical trial to determine whether early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by the primary care practitioner will improve their quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Individuals at least 18 years old

• Individuals must be symptomatic with respiratory symptoms

• Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.

• Individuals who have given written informed consent to participate in this trial in accordance with local regulations;

• Individual must be able to perform pre and post bronchodilator spirometry to measure lung function

⁃ Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):

• Individuals who have undiagnosed airflow obstruction on spirometry testing (i.e. Asthma or COPD) will be asked to participate in the RCT.

Locations
Other Locations
Canada
St. Joseph's Hamilton Healthcare
RECRUITING
Hamilton
Ottawa Hospital General Campus
RECRUITING
Ottawa
Institut universitaire de cardiologie et de pneumologie de Québec
NOT_YET_RECRUITING
Québec
Royal University Hospital
NOT_YET_RECRUITING
Saskatoon
Contact Information
Primary
Shawn Aaron, MD
saaron@toh.ca
6137378259
Backup
Kathy Vandemheen, MScN
kvandemheen@toh.ca
6137378259
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2029-12
Participants
Target number of participants: 420
Treatments
Experimental: Early diagnosis of previously undiagnosed asthma or COPD
On the day of randomization the participant will receive a copy of their interpreted spirometry report with a listed diagnosis. This report will be sent to their primary-care practitioner. In addition to the spirometry interpretation, the primary-care practitioner will be provided with a brief one-page guideline-based tool providing advice for pharmacologic and non-pharmacologic treatment of newly diagnosed asthma or COPD. The primary-care practitioner will be encouraged to see the participant as soon as possible to provide care. The participant will similarly be encouraged to make an appointment with the primary-care practitioner as soon as possible to access care for their condition
No_intervention: Delayed diagnosis of previously undiagnosed asthma or COPD
At the 12 week visit, participants randomized to the delayed diagnosis will complete the trial outcome assessments. After completing the 12 week final trial assessments they will be seen by the study respirologist and treated for their newly diagnosed asthma or COPD.
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov