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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
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This VA-based study will obtain feedback from healthcare workers via validated survey instrument on the comfort and tolerability of wearing current models of N95 respirators and novel respirator designs currently in development. There will be 4 novel respirators and 1 commonly used respirator (not locally used) to compare to a locally used respirator, which is familiar to participants. Comparisons will be examined between each of the first 5 models with the locally used control using Dunnett's t-test.
This study aims to compare novel designs to products currently in the marketplace by comparing scores on a survey tool which measures comfort and tolerability of respiratory protective devices. Study participants will be clinical healthcare workers who have experience wearing respiratory protective devices in their workplace. We will enroll up to 400 participants in the study, made up of physicians, nurses, nursing assistants and other healthcare employees who have previously been fit-tested to a N95 respirator. Subjects will be screened to determine eligibility and must pass fit-testing on the respirator he/she is randomized to. Participants will wear the respirator while performing a series of motions that simulate movements made by healthcare workers when performing patient care tasks. There will be no contact with patients during participation. Feedback via validated survey tool will be collected from all study participants on the comfort and tolerability of the respirator worn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Respirator Model | Active Comparator | Subjects randomized to the local respirator model will wear that model while performing study procedures. |
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| Non-Local Respirator Model | Active Comparator | Subjects randomized to the non-local respirator design will wear that model while performing study procedures. |
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| Prototype 1 Respirator Design | Experimental | Subjects randomized to the prototype 1 respirator design will wear that model while performing study procedures. |
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| Prototype 2 Respirator Design | Experimental | Subjects randomized to the prototype 2 respirator design will wear that model while performing study procedures. |
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| Prototype 3 Respirator Design | Experimental | Subjects randomized to the prototype 3 respirator design will wear that model while performing study procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Procedures | Other | Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| Measure | Description | Time Frame |
|---|---|---|
| To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Subject will participate in set study activities wearing the respirator that he/she was randomized to. Following, Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator. | Visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewis J Radonovich, MD | US Department of Veterans Affairs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malcom Randall VA Medical Center | Gainesville | Florida | 32608 | United States |
This study compares multiple respirators using same intervention (study activities). All subjects that pass fit-testing move on to intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Local Respirator Model | Subjects randomized to the local respirator model will wear that model while participating in study activities. Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. Novel Respirator Design |
| FG001 | Non-Local Respirator Model | Subjects randomized to the non-local respirator design will wear that model while participating in study activities. Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. Novel Respirator Design |
| FG002 | Prototype 1 Respirator Design | Subjects randomized to Prototype 1 respirator design will wear that model while participating in study activities. Prototype 1 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| FG003 | Prototype 2 Respirator Design | Subjects randomized to Prototype 2 respirator design will wear that model while participating in study activities. Prototype 2 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| FG004 | Prototype 3 Respirator Design | Subjects randomized to Prototype 3 respirator design will wear that model while participating in study activities. Prototype 3 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| FG005 | Prototype 4 Respirator Design | Subjects randomized to Prototype 4 respirator design will wear that model while participating in study activities. Prototype 4 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants were clinical healthcare workers at local Veterans Affairs Hospital or local University affiliate hospital.
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| ID | Title | Description |
|---|---|---|
| BG000 | Local Respirator Model | Subjects randomized to a current respirator model will wear that model while participating in study activities. Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | One local respirator model participant did not answer the age question. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Subject will participate in set study activities wearing the respirator that he/she was randomized to. Following, Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator. | Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn. | Posted | Mean | Standard Deviation | units on a scale | Visit 1 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Local Respirator Model | Subjects randomized to the local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Panic related to claustrophobia | Psychiatric disorders | Panic | Non-systematic Assessment | Subject started to panic from feelings of claustrophobia during fit-testing procedures. Respirator and fit-testing hood were removed and subject chose to withdrawal from further study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Eagan | National Center for Occupational Health and Infection Control | 352-376-1611 | 4973 | aaron.eagan@va.gov |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Prototype 4 Respirator Design |
| Experimental |
Subjects randomized to the prototype 4 respirator design will wear that model while performing study procedures. |
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| Visit 1 |
| Failed Fit-testing |
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| BG001 | Non-Local Respirator Model | Subjects randomized to a current respirator design will wear that model while participating in study activities. Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| BG002 | Prototype 1 Respirator Design | Subjects randomized to a novel respirator design will wear that model while participating in study activities. Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| BG003 | Prototype 2 Respirator Design | Subjects randomized to a novel respirator design will wear that model while participating in study activities. Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| BG004 | Prototype 3 Respirator Design | Subjects randomized to a novel respirator design will wear that model while participating in study activities. Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| BG005 | Prototype 4 Respirator Design | Subjects randomized to a novel respirator design will wear that model while participating in study activities. Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| BG006 | Total | Total of all reporting groups |
| Number |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Local Respirator Model | Subjects randomized to the local respirator model will wear that model while participating in study activities. Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| OG001 | Non-Local Respirator Model | Subjects randomized to the non-local respirator model will wear that model while participating in study activities. Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| OG002 | Prototype 1 Respirator Design | Subjects randomized to the Prototype 1 respirator design will wear that respirator while participating in study activities. Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| OG003 | Prototype 2 Respirator Design | Subjects randomized to the Prototype 2 respirator design will wear that respirator while participating in study activities. Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| OG004 | Prototype 3 Respirator Design | Subjects randomized to the Prototype 3 respirator design will wear that respirator while participating in study activities. Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
| OG005 | Prototype 4 Respirator Design | Subjects randomized to the Prototype 4 respirator design will wear that respirator while participating in study activities. Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn. |
|
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| Secondary | To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator. | Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn. | Posted | Mean | Standard Deviation | units on a scale | Visit 1 |
|
|
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| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Non-Local Respirator Model | Subjects randomized to the non-local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated. | 0 | 61 | 0 | 61 |
| EG002 | Prototype 1 Respirator Design | Subjects randomized to Prototype 1 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated. | 0 | 52 | 0 | 52 |
| EG003 | Prototype 2 Respirator Design | Subjects randomized to Prototype 2 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated. | 0 | 72 | 0 | 72 |
| EG004 | Prototype 3 Respirator Design | Subjects randomized to Prototype 3 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated. | 0 | 68 | 1 | 68 |
| EG005 | Prototype 4 Respirator Design | Subjects randomized to Prototype 4 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated. | 0 | 63 | 0 | 63 |
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