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Clinician Satisfaction With the VERABAND™

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VERABAND information
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Any treating clinician at a recruiting tertiary pain clinic will be eligible to participate. Patient participants must meet the following criteria: Inclusion Criteria: Ambulatory Diagnosis of chronic low back pain (cLBP) according to the criteria of National Institute of Health (NIH) Task Force on Research Standards for cLBP Answering 'Yes' to the question: Does your low back pain interfere with your mobility? Starting any new non-surgical treatment or combination of treatments for cLBP as part of their normal ongoing care, including medications; physical therapy/exercise; integrated therapies (e.g., massage, acupuncture, yoga); cognitive- behavioral therapy; and/or interventional procedures (e.g., epidural steroid or facet joint injections) Willingness to wear a VERABAND™ continuously until their next clinic visit and return used devices in the mail. Exclusion Criteria: Clinical findings suggesting the presence of ongoing systemic disease, including fever, weight loss, initiation of pain following major trauma, immunosuppression, intravenous drug use, recent bacterial infection, severe or persistent sensory or motor involvement of bowel, bladder, or lower extremity; or any condition that would greatly limit physical activity not due to pain. Inability to speak and write English. Visual or hearing difficulties that would preclude participation. Severe psychiatric disorders that in the opinion of the investigative team would interfere with participation in the study. This includes any active suicidal ideations or history of suicide attempts. Exclusions will be based on self-reported medical history or chart review and in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. Individuals receiving disability or compensation or involved in litigation. Scheduled surgery before follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    VERABAND information

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Measure clinician satisfaction of the usability of the VERABAND™ 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.
    Measure the likelihood of clinical adoption of the VERABAND™ 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 VERABAND™

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2023
    Last Updated
    October 6, 2023
    Sponsor
    University of Michigan
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS), Arbor Medical Innovations, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06080464
    Brief Title
    Clinician Satisfaction With the VERABAND™
    Official Title
    A Study of Clinician Satisfaction and Likelihood of Clinical Adoption of the VERABAND™
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    June 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS), Arbor Medical Innovations, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low-back Pain

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    360 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VERABAND information
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    VERABAND information
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Measure clinician satisfaction of the usability of the VERABAND™ using the System Usability Scale (SUS)
    Description
    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.
    Time Frame
    approximately 7 weeks
    Title
    Measure the likelihood of clinical adoption of the VERABAND™ using Item 1 of the System Usability Scale (SUS)
    Description
    The SUS item is a five-point scale Likert response ranging from 1-5. Higher scores indicate increase likelihood of clinical adoption of the VERABAND™
    Time Frame
    approximately 7 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Any treating clinician at a recruiting tertiary pain clinic will be eligible to participate. Patient participants must meet the following criteria: Inclusion Criteria: Ambulatory Diagnosis of chronic low back pain (cLBP) according to the criteria of National Institute of Health (NIH) Task Force on Research Standards for cLBP Answering 'Yes' to the question: Does your low back pain interfere with your mobility? Starting any new non-surgical treatment or combination of treatments for cLBP as part of their normal ongoing care, including medications; physical therapy/exercise; integrated therapies (e.g., massage, acupuncture, yoga); cognitive- behavioral therapy; and/or interventional procedures (e.g., epidural steroid or facet joint injections) Willingness to wear a VERABAND™ continuously until their next clinic visit and return used devices in the mail. Exclusion Criteria: Clinical findings suggesting the presence of ongoing systemic disease, including fever, weight loss, initiation of pain following major trauma, immunosuppression, intravenous drug use, recent bacterial infection, severe or persistent sensory or motor involvement of bowel, bladder, or lower extremity; or any condition that would greatly limit physical activity not due to pain. Inability to speak and write English. Visual or hearing difficulties that would preclude participation. Severe psychiatric disorders that in the opinion of the investigative team would interfere with participation in the study. This includes any active suicidal ideations or history of suicide attempts. Exclusions will be based on self-reported medical history or chart review and in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. Individuals receiving disability or compensation or involved in litigation. Scheduled surgery before follow-up.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristi Pickup, MSW
    Phone
    734-764-4072
    Email
    knpicku@med.umich.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Whibley, PhD
    Organizational Affiliation
    University of Michigan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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