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| ID | Type | Description | Link |
|---|---|---|---|
| 1U44NS122002 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Arbor Medical Innovations, LLC | UNKNOWN |
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The VERABANDâ„¢ is a newly-developed, disposable, wearable activity monitor. The researchers will assess clinician satisfaction with the usability and likelihood of clinical adoption of the newly-developed, disposable, wearable activity monitor, across multiple clinical sites in the chronic low back pain (cLBP) population.
A total of 340 cLBP patients (estimating n=300 completers) will be recruited and evaluated under an approved institutional review board (IRB) protocol by a total of 20 clinician participants distributed across multiple tertiary pain clinics. Consented patient participants will be given a VERABANDâ„¢ activity monitor during an initial clinic visit (baseline) and will then be tracked longitudinally after beginning a new pain treatment regime as part of their normal ongoing care. VERABANDâ„¢ activity data reports (including a summary broken down by week) will subsequently be provided to treating clinicians prior to each patient's follow-up clinic visit. The primary outcome will be clinician satisfaction with usability of the VERABANDâ„¢ system to support clinical cLBP management, regardless of the specific treatment(s) implemented or their analgesic effectiveness. Each clinician will complete a usability satisfaction survey at the end of each patient's episode of care, which allows for exploratory analyses to identify whether the VERABANDâ„¢ system is perceived to be more useful for specific patient phenotypes (e.g., those with higher levels of pain and/or disability or specific psychological characteristics).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VERABAND information | Experimental | Consented patient participants will be given a VERABANDâ„¢ activity monitor during an initial clinic visit (baseline) and will then be tracked longitudinally after beginning a new pain treatment regime as part of their normal ongoing care. VERABANDâ„¢ activity data reports (including a summary broken down by week) will subsequently be provided to treating clinicians prior to each patient's follow-up clinic visit. The arm is all of the clinicians of the participants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VERABAND information | Other | The device, VERABANDâ„¢, activity data reports (including a summary broken down by week) will be provided to treating clinicians prior to each patient's follow-up clinic visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure clinician satisfaction of the usability of the VERABANDâ„¢ using the System Usability Scale (SUS) | The SUS is comprised of 10 statements: Each statement is accompanied by a five-point scale Likert response option. The SUS ranges from 10-50 and the higher scores indicate higher clinician satisfaction with usability. | approximately 7 weeks |
| Measure the likelihood of clinical adoption of the VERABANDâ„¢ using Item 1 of the System Usability Scale (SUS) | The SUS item is a five-point scale Likert response ranging from 1-5. Higher scores indicate increase likelihood of clinical adoption of the VERABANDâ„¢ | approximately 7 weeks |
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Any treating clinician at a recruiting tertiary pain clinic will be eligible to participate.
Patient participants must meet the following criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristi Pickup, MSW | Contact | 734-764-4072 | knpicku@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Whibley, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute | Not yet recruiting | La Jolla | California | 92037 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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