Comfort, Tolerability
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERStudy Procedures
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.
Sponsors
VA Office of Research and Development
National Center for Occupational Health and Infection Control
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* VA or UF Health Shands Hospital clinical healthcare worker * Has been previously fit-tested to a N95 respirator * Is able to pass fit-testing on the model of respirator he/she is randomized to
Exclusion criteria
* Does not meet study inclusion criteria * Is pregnant * Has a health condition that prevents him/her from wearing a respirator * Has physical characteristics that may interfere with his/her ability to attain an adequate facial seal when fit-tested (e.g. growth of facial hair, facial scarring) * Has any condition which could, in the opinion of the investigator, place the participant at risk or interfere with data integrity. This includes a previous reaction to inhalation of both the Bitrex or saccharin solution used during fit-testing procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Visit 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | Visit 1 | 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. |
Countries
United States
Participant flow
Pre-assignment details
This study compares multiple respirators using same intervention (study activities). All subjects that pass fit-testing move on to intervention.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| 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. | 53 |
| 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. | 38 |
| 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. | 68 |
| 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. | 64 |
| 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. | 56 |
| Total | 337 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Failed Fit-testing | 8 | 8 | 14 | 4 | 3 | 7 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Local Respirator Model | Non-Local Respirator Model | Prototype 1 Respirator Design | Prototype 2 Respirator Design | Prototype 3 Respirator Design | Prototype 4 Respirator Design | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 1 participants | 0 participants | 1 participants | 0 participants | 2 participants | 1 participants | 5 participants |
| Age, Categorical Between 18 and 65 years | 56 participants | 53 participants | 37 participants | 68 participants | 62 participants | 55 participants | 331 participants |
| Sex: Female, Male Female | 48 Participants | 37 Participants | 32 Participants | 51 Participants | 44 Participants | 37 Participants | 249 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 6 Participants | 17 Participants | 20 Participants | 19 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 61 | 0 / 52 | 0 / 72 | 1 / 68 | 0 / 63 |
| serious Total, serious adverse events | 0 / 66 | 0 / 61 | 0 / 52 | 0 / 72 | 0 / 68 | 0 / 63 |
Outcome results
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.
Time frame: Visit 1
Population: Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Local Respirator Model | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Discomfort | 5.0 units on a scale | Standard Deviation 3.8 |
| Local Respirator Model | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Wearing | 1.4 units on a scale | Standard Deviation 1.8 |
| Non-Local Respirator Model | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Discomfort | 4.6 units on a scale | Standard Deviation 3.6 |
| Non-Local Respirator Model | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Wearing | 1.1 units on a scale | Standard Deviation 1.5 |
| Prototype 1 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Discomfort | 3.7 units on a scale | Standard Deviation 2.8 |
| Prototype 1 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Wearing | 0.7 units on a scale | Standard Deviation 1 |
| Prototype 2 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Discomfort | 4.0 units on a scale | Standard Deviation 3.1 |
| Prototype 2 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Wearing | 1.1 units on a scale | Standard Deviation 1.8 |
| Prototype 3 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Discomfort | 3.3 units on a scale | Standard Deviation 2.5 |
| Prototype 3 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Wearing | 0.7 units on a scale | Standard Deviation 1.3 |
| Prototype 4 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Discomfort | 3.1 units on a scale | Standard Deviation 2.8 |
| Prototype 4 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Wearing | 0.9 units on a scale | Standard Deviation 1.4 |
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.
Time frame: Visit 1
Population: Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Respirator Model | To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | 9.4 units on a scale | Standard Deviation 7.5 |
| Non-Local Respirator Model | To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | 8.3 units on a scale | Standard Deviation 6.3 |
| Prototype 1 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | 5.8 units on a scale | Standard Deviation 4.5 |
| Prototype 2 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | 7.6 units on a scale | Standard Deviation 6.4 |
| Prototype 3 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | 6.1 units on a scale | Standard Deviation 4.9 |
| Prototype 4 Respirator Design | To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs | 5.7 units on a scale | Standard Deviation 4.4 |