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| Name | Class |
|---|---|
| Instituto de Cancer Dr Arnaldo | UNKNOWN |
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Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provox Life HME | Experimental | Use of Provox Life HMEs and attachment |
|
| Control - No HME | No Intervention | Control group is current standard of Care in Brazil, which is not using an HME |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provox Life | Device | Compliant use of Provox Life HMEs |
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| Measure | Description | Time Frame |
|---|---|---|
| CASA-Q Score | assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact. | Baseline, 3 months, 6 months, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of involuntary coughs per 24 hours | Patient reported, recorded by tally sheeting | Baseline, 3 months, 6 months, 9 months |
| Forced Expectoration | Patient reported, recorded by tally sheeting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Cancer Dr. Arnaldo | São Paulo | Brazil |
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Randomized Controlled Trial
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| Baseline, 3 months, 6 months, 9 months |
| Quality of Life by EQ-5D-5L | patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility | Baseline, 3 months, 6 months, 9 months |
| Jenkins sleep evaluation questionnaire | Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances | Baseline, 3 months, 6 months, 9 months |
| Questionnaire to assess Shortness of Breath | from Ackerstaff et al., 1993 | Baseline, 3 months, 6 months, 9 months |
| Voice handicap Index | patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap. | Baseline, 3 months, 6 months, 9 months |
| Consumption of medical devices (Number of devices used) | Number of devices used, by use of patient diary recoding number of devices used | Baseline, 3 months, 6 months, 9 months |
| Study-specific questionnaire to assess number of complications and medical treatments | Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave | Baseline, 3 months, 6 months, 9 months |