VERABAND for Clinician Satisfaction

Overseen By Kristi Pickup, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Systemic disease, Psychiatric disorders, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device called the VERABAND™ to assess doctor satisfaction with its use for patients with chronic low back pain. The device tracks activity and sends reports to doctors to aid in managing patient care. The trial seeks individuals experiencing low back pain that affects movement and who are beginning a new non-surgical treatment. Participants must be able to walk, willing to wear the device until their next clinic visit, and return it by mail. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future patient care.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. It mentions that you can start new treatments, including medications, as part of your normal care.

What prior data suggests that the VERABAND is safe for use in clinical settings?

Research shows that the VERABAND is a wearable device used to track activity during the day and while sleeping. Early results suggest it is safe because it only collects and stores data. No reports of serious side effects have emerged from wearing these types of monitors.

This trial focuses on healthcare providers' satisfaction with the device, not its safety for users. Testing in a clinical setting suggests that any major safety issues have likely been addressed. The trial is labeled "Not Applicable," indicating it examines the device's usefulness in a healthcare setting rather than side effects.

Overall, the VERABAND appears well-tolerated, similar to other common activity monitors, which are generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VERABAND trial because it aims to enhance clinician satisfaction and potentially improve patient care through advanced data tracking. Unlike traditional pain management approaches that rely heavily on subjective patient feedback, VERABAND provides clinicians with objective, detailed weekly reports on patient activity levels. This innovative approach can offer a clearer picture of how patients respond to their pain treatments over time, allowing for more tailored and effective care strategies. By integrating technology into routine clinical practice, VERABAND could transform how clinicians monitor treatment effectiveness and adjust pain management plans.

What evidence suggests that the VERABAND activity monitor is effective for clinician satisfaction in chronic low back pain?

The VERABAND™ is a new wearable device designed to help manage chronic low back pain (cLBP). In this trial, clinicians will receive activity data from the VERABAND™ device, enabling them to track and adjust treatments more effectively. The device provides detailed weekly reports, which may assist doctors in making more informed treatment decisions. Although direct evidence on its pain management effectiveness is not yet available, the device aims to enhance doctor satisfaction and treatment efficacy in managing cLBP. ^{2 6 7 8 9}

Who Is on the Research Team?

Daniel Whibley, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for clinicians treating patients with chronic low back pain (cLBP) at tertiary pain clinics. Participants must diagnose cLBP as per NIH standards, have patients whose mobility is affected by cLBP, and be starting new non-surgical treatments. Clinicians should be willing to wear the VERABAND™ until the next clinic visit.

Inclusion Criteria

Eligibility for participation is restricted to treating clinicians at a recruiting tertiary pain clinic.

You must be prepared to wear a VERABAND™ continually until your next clinic appointment and return the utilized apparatuses via mail.

I have been diagnosed with chronic low back pain by NIH standards.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants are given a VERABAND™ activity monitor during an initial clinic visit

1 day

1 visit (in-person)

Longitudinal Tracking

Participants are tracked longitudinally after beginning a new pain treatment regime as part of their normal ongoing care

7 weeks

Weekly data reports provided to clinicians

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VERABAND

Trial Overview The study evaluates clinician satisfaction with the VERABAND™, a disposable wearable activity monitor designed for chronic low back pain management. It aims to determine its usability and potential for clinical adoption across various sites.

How Is the Trial Designed?

Group I: VERABAND information Experimental Treatment 1 Intervention

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 arm is all of the clinicians of the participants.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Arbor Medical Innovations, LLC

Collaborator

Trials

1

Recruited

360+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06080464?draw=2&rank=1

NCT06080464 | Clinician Satisfaction With the VERABAND™ The primary outcome will be clinician satisfaction with usability of the VERABAND™ system to support clinical cLBP management, regardless of the specific ...

2. trial.medpath.com trial.medpath.com/clinical-trial/27b5ac5a6bca54c1/nct06080464-study-clinician-satisfaction-veraband

Clinician Satisfaction With the VERABAND™ | MedPath 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11461569/

The Role of Patient-Reported Outcomes to Measure ... This article describes the role of treatment satisfaction in drug development as well as regulatory and Health Technology Assessment (HTA) decision making.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822959

Electronic Health Record Usability, Satisfaction, and ... This survey study measures physician satisfaction with their electronic health record and its usability and evaluates the association of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11362862/

Electronic Health Record Usability, Satisfaction, and ... This survey study of 2067 family physicians found that there was significant variation in usability across EHR functions, with alerts receiving the lowest ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233987.pdf

Arbor Medical Innovations, LLC Kay Fuller President ... VERABAND™ is intended to acquire and store data while being worn during normal activities and/or during sleep. The device consists of a wearable.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27471185/

Armband activity monitor data do not correlate with ... Armband activity monitor data do not correlate with reported pain scores in patients receiving vertebroplasty. J Neurointerv Surg. 2017 Sep;9 ...

8. awhonn.org awhonn.org/

AWHONN- Association of Women's Health, Obstetric and ... AWHONN offers resources for obstetric patient safety, fetal heart monitoring, critical care, staffing, vaccination, and post-birth warning ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3543867/

BEST PRACTICES FOR USING PHYSICAL ACTIVITY ... In this report we review the major purpose for using physical activity monitors in different types of population-based study.