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This pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. The results of this one-time short questionnaire will inform development of a novel naloxone delivery device.
All opioid overdose related deaths can be prevented with the timely delivery of Naloxone. This study is a one-time, preliminary survey of participants with opioid use disorder to assess the need for, and community attitudes towards, a wearable device capable of autonomously detecting and responding to an opioid overdose. The results of this survey will be used to guide ongoing development of a de novo device. This study will be conducted over a 3 month period and survey participants from the Kensington Neighborhood in North Philadelphia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Participants | This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Community Need for a Device-based Opioid Overdose Intervention | We aim to characterize the degree of need for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | We aim to characterize the functional and aesthetic preferences of the participant population for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview. | Day 1 |
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Inclusion Criteria:
Have used opioids for more than 3 months or will be having surgery where opioids will be administered
Exclusion Criteria:
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Study population is non-pregnant individuals over the age of 21 with opioid use disorder.
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Brenner, MD/PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prevention Point Philadelphia | Philadelphia | Pennsylvania | 19134 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34301246 | Derived | Kanter K, Gallagher R, Eweje F, Lee A, Gordon D, Landy S, Gasior J, Soto-Calderon H, Cronholm PF, Cocchiaro B, Weimer J, Roth A, Lankenau S, Brenner J. Willingness to use a wearable device capable of detecting and reversing overdose among people who use opioids in Philadelphia. Harm Reduct J. 2021 Jul 23;18(1):75. doi: 10.1186/s12954-021-00522-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Participants | This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device. Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention. Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Participants | This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device. Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention. Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Community Need for a Device-based Opioid Overdose Intervention | We aim to characterize the degree of need for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview. | Some participants did not answer all the questions or selected more than one answer | Posted | Count of Participants | Participants | Day 1 |
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Adverse event data was collected at the time of survey administration (1 hour).
Participants were asked to complete a survey and participate in an interview. There is no risk for mortality or serious adverse events from these activities.
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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 | Patient Participants | This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device. Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention. Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacob Brenner, Assistant Professor of Medicine | Hospital of the University of Pennsylvania | 215-662-2222 | Jacob.Brenner@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2020 | Jun 12, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2020 | Jun 12, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Interview | Other | Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device. |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Housing Status | Count of Participants | Participants |
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| Started After Injury/Surgery | Count of Participants | Participants |
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| Duration of Opioid Use | Mean | Inter-Quartile Range | years |
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| Opioid Use Frequency (Days per Week) | Count of Participants | Participants |
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| Opioid Use Frequency (Uses per Day) | Count of Participants | Participants |
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| Been to an Inpatient Rehab | Count of Participants | Participants |
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| Used MOUD | Count of Participants | Participants |
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| Perceived likelihood of bystander intervention in the event of an overdose | Count of Participants | Participants |
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| Friends/Family Who have Overdosed | Count of Participants | Participants |
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| Friends/Family Who have had Overdose Complications | Count of Participants | Participants |
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| Friends/Family Who have Died from Overdose | Count of Participants | Participants |
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| Has Overdosed | Count of Participants | Participants |
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| Number of Prior Overdoses | Mean | Inter-Quartile Range | Incidents |
|
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| Secondary | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | We aim to characterize the functional and aesthetic preferences of the participant population for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview. | Some participants did not answer all the questions or selected more than one answer | Posted | Count of Participants | Participants | Day 1 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 97 |
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| D000079524 |
| Narcotic-Related Disorders |
| D001523 | Mental Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Likely to use a device that indicates the wearer is at risk of an overdose |
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| Likely to use a device that straps naloxone to the body for a bystander to administer |
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| Likely to use a device that senses an overdose and administers naloxone if needed |
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| Likely to use a device that alerts medical first responders if needed |
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| Likely to use a device that alerts bystanders if needed |
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| Likely to use a device that monitors vital signs |
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| For a device that sense overdose - likely to wear a necklace |
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| For a device that sense overdose - likely to wear a canula |
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| For a device that sense overdose - likely to wear a skin-patch on chest |
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| For a device that sense overdose - likely to wear a skin-patch on upper arm |
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| For a device that sense overdose - likely to wear a watch-appearing bracelet |
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| For a device that sense overdose - likely to wear a wrist bracelet |
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| For a device that sense overdose - likely to wear a shoulder strap |
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| For a device that sense overdose - likely to wear a thigh strap |
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| For a device that sense overdose - likely to wear a chest strap |
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| For a device that sense overdose - likely to wear glasses |
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| For a device that sense overdose - likely to wear a knee brace |
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| For a device that sense overdose - likely to wear an ankle strap |
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