Asthma, COPD
Conditions
Brief summary
Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted casefinding to find people with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. The investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.
Interventions
DRUGTreatment strategy using evidence-based guidelines for asthma or COPD
The respirologist will determine the clinical extent of the patient's symptoms, activity limitation, and degree of airflow obstruction and will commence the subject on asthma or COPD medications if indicated
BEHAVIORALSmoking Cessation
Smoking cessation counselling by a qualified educator if currently smoking
BEHAVIORALParticipant Education
Standardized education for asthma or COPD disease
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects at least 18 years old; * Subjects who score \> or = to 6 points on The Asthma Screening Questionnaire or \> 19.5 points on The COPD Diagnostic Questionnaire; * Subjects who have given written informed consent to participate in this trial in accordance with local regulations; * Subjects able to perform pre and post bronchodilator spirometry to measure lung function; Additional Inclusion Criteria for RCT: Those subjects who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose FEV1 improves by \> 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the RCT.
Exclusion criteria
* Subjects who report a previous physician diagnosis of asthma. * Subjects who report a previous physician diagnosis of COPD * Subjects with any of the following conditions within the past 3 months: Heart attack or hospitalization for other heart problems; Stroke; Aortic or cerebral aneurysm; Detached retina or eye surgery * Subjects who are in the third trimester of pregnancy * Subjects involved in another interventional trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual rate of patient initiated healthcare utilization events for respiratory illness | 12 months | Number of visits for respiratory illnesses divided by the length of time in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing. | 12 months | The change will be expressed as the mean change in the FEV1 measurements at 12 months in comparison to the lung function measurements on the day of randomization. |
| Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire | 12 months | The change in general health status will be expressed as the total score of the SF-36 Health Survey Questionnaire at 12 months minus the score on the day of randomization. A total change of 8-10 points in the SF-36 has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate better health status. |
| Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). | 12 months | The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 months minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status. |
| Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT) | 12 months | The change in overall respiratory symptom burden will be expressed as the total score of the COPD Assessment Test at 12 months minus the score on the day of randomization. A total change of - 2 points in the CAT total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate higher burden. |
| Smoking cessation rate | 12 months | The number of participants who quit smoking over the 12 month period. |
Countries
Canada
Outcome results
None listed