Trials / Recruiting
RecruitingNCT06080464
Clinician Satisfaction With the VERABAND™
A Study of Clinician Satisfaction and Likelihood of Clinical Adoption of the VERABAND™
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The VERABAND™ 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.
Detailed description
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 VERABAND™ 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. VERABAND™ 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 VERABAND™ 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 VERABAND™ 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | VERABAND information | The device, VERABAND™, 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. |
Timeline
- Start date
- 2025-06-09
- Primary completion
- 2026-12-01
- Completion
- 2027-06-01
- First posted
- 2023-10-12
- Last updated
- 2026-03-25
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06080464. Inclusion in this directory is not an endorsement.