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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early diagnosis of previously undiagnosed asthma or COPD | Experimental | 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 |
|
| Delayed diagnosis of previously undiagnosed asthma or COPD | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early diagnosis and treatment | Other | Early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). | The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 weeks 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT) | The change in overall respiratory symptom burden will be expressed as the total score of the COPD Assessment Test at 12 weeks 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. |
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Inclusion Criteria:
Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawn Aaron, MD | Contact | 6137378259 | saaron@toh.ca | |
| Kathy Vandemheen, MScN | Contact | 6137378259 | kvandemheen@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Shawn Aaron, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hamilton Healthcare | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 12 weeks |
| Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing. | The change will be expressed as the mean change in the FEV1 measurements at 12 weeks in comparison to the lung function measurements on the day of randomization. | 12 weeks |
| Differences between the experimental group and the control group in patient-initiated urgent healthcare utilization events for respiratory illness over the 12-week trial period. | Differences between groups in patient-initiated urgent healthcare utilization events for respiratory illness over the 12-week trial period. | 12 weeks |
| Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes | The baseline dyspnea index (BDI) is used to rate the severity of dyspnea at a single point in time and the transitional dyspnea index (TDI) is used to assess change in dyspnea at 12 weeks. The differences between the experimental group and the control group TDI measured at 12 weeks. | 12 weeks |
| Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI) | The change in absenteeism and presenteeism will be assessed over the 12 week study period. Higher scores indicate greater impairment in work productivity and daily activities | 12 weeks |
| Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire | The change in general health status will be expressed as the total score of the SF-36 Health Survey Questionnaire at 12 weeks 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. | 12 weeks |
| Ottawa Hospital General Campus | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
|
| Royal University Hospital | Recruiting | Saskatoon | Saskatchewan | Canada |
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| Institut universitaire de cardiologie et de pneumologie de Québec | Recruiting | Québec | G1V 4G5 | Canada |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |