Smoking Cessation, Smoking, Tobacco
Conditions
Brief summary
Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.
Detailed description
The objectives of this Human Factors/Usability study are to: * Ensure that representative intended users are able to operate the Pivot Breath Sensor independently * Validate appropriate mitigations of use related hazards identified in risk management documentation * Uncover previously unforeseen use errors This human factors and usability testing is conducted to demonstrate that the Pivot Breath Sensor can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions.
Interventions
DEVICEPivot Breath Sensor
The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Sponsors
UserWise, LLC
Jennifer Marler, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-80 years of age * English speaking * Owns and uses a smartphone * Willing to sign the Informed Consent Form
Exclusion criteria
* Prior experience with a study sponsored by Carrot Inc * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in. | User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device, and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes. Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 60 minutes. |
| Human Factors - User Documentation Assessment With Observer Ratings | Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session. | Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes. Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute each. The User documentation assessment portion of the study session will last up to 30 minutes. |
| Human Factors - Subjective Feedback Questionnaire | Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session. | Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes. Subjective feedback focusing on any concerns prior to the conclusion of the study session. Subjective feedback questions will take approximately 1-3 minutes each. The Subjective feedback portion of the study session will last up to 5 to 15 minutes. |
| Human Factors - Participant Feedback Using Rating Scale | Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session. | Participant will be asked to provide ratings on the following: * How would you rate the ease or difficulty using the device? * How clear or unclear was the Quick Start Guide? * How clear or unclear was the Packaging? * How clear or unclear was the User Manual? * How easy or difficult was it to understand and interpret the test results? The participant will use the following rating scale (higher score = better outcome): 5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult 1 - Very difficult For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes. Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pivot Breath Sensor (User Group) Self-reported daily smokers of 2 or more cigarettes per day
Pivot Breath Sensor: The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Pivot Breath Sensor (User Group) |
|---|---|
| Age, Customized Age Age 18-49 years | 13 Participants |
| Age, Customized Age Age 49-50 years | 2 Participants |
| Daily Smoking Frequency (cigarettes per day) 11-15 cpd | 4 Participants |
| Daily Smoking Frequency (cigarettes per day) 16+ cpd | 5 Participants |
| Daily Smoking Frequency (cigarettes per day) 2-5 cpd | 2 Participants |
| Daily Smoking Frequency (cigarettes per day) 6-10 cpd | 4 Participants |
| Race/Ethnicity, Customized Ethnicity African American | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 10 Participants |
| Race/Ethnicity, Customized Ethnicity Middle Eastern | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Native American | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 1 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Human Factors - Participant Feedback Using Rating Scale
Participant will be asked to provide ratings on the following: * How would you rate the ease or difficulty using the device? * How clear or unclear was the Quick Start Guide? * How clear or unclear was the Packaging? * How clear or unclear was the User Manual? * How easy or difficult was it to understand and interpret the test results? The participant will use the following rating scale (higher score = better outcome): 5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult 1 - Very difficult For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes. Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each.
Time frame: Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How would you rate the ease or difficulty of using the device? | very easy/very clear | 5 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How would you rate the ease or difficulty of using the device? | easy/clear | 8 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How would you rate the ease or difficulty of using the device? | neither easy/clear nor difficult/unclear | 2 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How would you rate the ease or difficulty of using the device? | difficult/unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How would you rate the ease or difficulty of using the device? | very difficult/very unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? | very easy/very clear | 8 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? | easy/clear | 6 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? | neither easy/clear nor difficult/unclear | 1 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? | difficult/unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? | very difficult/very unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the packaging? | very easy/very clear | 9 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the packaging? | easy/clear | 5 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the packaging? | neither easy/clear nor difficult/unclear | 1 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the packaging? | difficult/unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the packaging? | very difficult/very unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? | very easy/very clear | 11 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? | easy/clear | 4 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? | neither easy/clear nor difficult/unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? | difficult/unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? | very difficult/very unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? | very easy/very clear | 5 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? | easy/clear | 8 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? | neither easy/clear nor difficult/unclear | 2 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? | difficult/unclear | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? | very difficult/very unclear | 0 Participants |
Primary
Human Factors - Subjective Feedback Questionnaire
Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes. Subjective feedback focusing on any concerns prior to the conclusion of the study session. Subjective feedback questions will take approximately 1-3 minutes each. The Subjective feedback portion of the study session will last up to 5 to 15 minutes.
Time frame: Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pivot Breath Sensor (User Group) | Human Factors - Subjective Feedback Questionnaire | Dd you experience any moments of hesitation while using the product? | yes | 10 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Subjective Feedback Questionnaire | Dd you experience any moments of hesitation while using the product? | no | 5 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Subjective Feedback Questionnaire | Do you have any safety concerns regarding this product or its labeling? | yes | 3 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - Subjective Feedback Questionnaire | Do you have any safety concerns regarding this product or its labeling? | no | 12 Participants |
Primary
Human Factors - User Documentation Assessment With Observer Ratings
Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes. Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute each. The User documentation assessment portion of the study session will last up to 30 minutes.
Time frame: Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pivot Breath Sensor (User Group) | Human Factors - User Documentation Assessment With Observer Ratings | understanding of the packaging | Successful | 15 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Documentation Assessment With Observer Ratings | understanding of the packaging | Unsuccessful | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Documentation Assessment With Observer Ratings | understanding of the quick start guide | Successful | 14 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Documentation Assessment With Observer Ratings | understanding of the quick start guide | Unsuccessful | 1 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Documentation Assessment With Observer Ratings | understanding of the user manual | Successful | 15 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Documentation Assessment With Observer Ratings | understanding of the user manual | Unsuccessful | 0 Participants |
Primary
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings
User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device, and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 60 minutes. Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 60 minutes.
Time frame: Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pivot Breath Sensor (User Group) | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | Set up device - open packaging | Successful | 15 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | Set up device - open packaging | Unsuccessful | 0 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | Use device | Successful | 14 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | Use device | Unsuccessful | 1 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | Interpret results | Successful | 15 Participants |
| Pivot Breath Sensor (User Group) | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | Interpret results | Unsuccessful | 0 Participants |