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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
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The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use.
This study will use a prospective interventional comparative study design using the patient's quality of life (QoL) as the primary study endpoint to determine HFCWO affect. The study will compare the patient's QoL baseline (established at enrollment prior to HFCWO treatment) to the QoL measured at various timepoints (enrollment, 2 months, 6 months and 12 months) over a one-year period whilst receiving HFCWO treatment. In addition, a baseline for the secondary endpoints will established at enrollment for comparison to measurements taken at various timepoints over a one-year period whilst receiving HFCWO treatment. The patient's medical records will be used to establish prior histories of exacerbation rates for comparison to exacerbation rates experienced after one year of HFCWO treatment. Patients will serve as their own control.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartVest Airway Clearance System | Device | Pulmonary airway clearance of retained mucus via high frequency chest wall oscillation (SmartVest) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL): Quality of Life-Bronchiectasis (QOL-B) questionnaire | The primary endpoint is the subject's quality of life (QoL) using the Quality of Life-Bronchiectasis (QOL-B) questionnaire as the measurement tool. QoL measured at enrollment (baseline) will be compared to QoL measured at 2 months, 6 months and 1 year. The previously validated questionnaire is titled "Quality of Life Questionnaire - Bronchiectasis". The Likert style questionnaire asks the subject to subjectively rank their symptoms using a 4 scale base ranging from "a lot of difficulty" to "no difficulty" and "always" to "never". | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Measurements |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| George Solomon, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham (UAB University Hospital) | Birmingham | Alabama | 35233-2110 | United States | ||
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| 1 year |
| Emory University School of Medicine |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| The University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | United States |