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Completed

NCT Number: NCT05122663

Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo

ED-VeRT will enroll up to 125 adult emergency department (ED) patients presenting with a chief complaint of dizziness or vertigo to collect longitudinal outcomes over 3 months of follow-up. This will include 50 patients who were evaluated by an ED physical therapist (ie, vestibular rehabilitation) during their ED visit and 50 patients who received usual care. The aims of this trial are to: (1) obtain initial estimates of participant recruitment and retention, intra-cluster correlation, and between-group outcome differences that will inform sample size calculation for a future randomized clinical trial, and (2) assess feasibility and fidelity of a clinical classification protocol for undifferentiated dizziness among patients receiving ED vestibular rehabilitation.

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Key information

Conditions

Dizziness Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chief complaint relating to dizziness or vertigo
  • Ability to complete follow-up data collection electronically or by telephone
  • English-speaking

Exclusion criteria

  • Severe neurologic deficit concerning for ischemic or hemorrhagic stroke
  • Known pregnancy, under police custody, unable to consent

Treatment and study plan

Vestibular rehabilitation

Behavioral

Vestibular Rehabilitation refers to the specific interventions that physical therapists provide to patients with dizziness and vertigo symptoms. These interventions can involve repositioning maneuvers, habituation exercises, gaze stabilization, and/or balance training exercises, depending on the specific etiology of dizziness and vertigo per an established clinical protocol utilizing a patient's history and exam findings. Physical therapists instruct patients in how to perform these exercises at home and provide instructions and referral for patients to follow-up with an outpatient physical therapist for further care.

Usual Care

Other

Usual Care refers to any combination of diagnostic testing, medications, and patient education or counseling provided by a patient's treating ED physician.

Primary outcomes

  1. Dizziness Handicap Inventory (DHI)

    Time frame: Three months after the index ED visit.

    The DHI contains 25 items quantifying self-perceived handicapping effects of dizziness symptoms.

Secondary outcomes

  1. Vestibular Activities Avoidance Instrument (VAAI-9)

    Time frame: Three months after the index ED visit.

    The VAAI-9 identifies fear avoidance beliefs in persons with dizziness. The VAAI-9 is the 9-item short form version of the VAAI.

  2. ED Diagnostic Imaging Utilization

    Time frame: Index ED visit (one day)

    The proportion of ED visits in which any diagnostic imaging of the brain was performed, including computed tomography and magnetic resonance imaging.

  3. ED Length of Stay

    Time frame: Index ED visit (up to one week)

    Total length of stay, inclusive of hospitalizations and observation stays.

  4. Patient-Reported Medication Use in Last 24 Hours

    Time frame: Three months after the index ED visit.

    Patient-reported medication use for dizziness will be collected using a standardized instrument assess whether participants have taken any dizziness medication in the last 24 hours (binary yes/no). The 24-hour timeframe was selected to maximize accuracy in patient recall. In brief, dizziness medications are listed by brand and generic names; a "yes" response to any medication triggers an additional query asking the participant to specify the medication dose (e.g., meclizine 25mg) and quantity (e.g., one pill).

Other outcomes

  1. Global Rating of Change (GROC)

    Time frame: Three months after the index ED visit.

    The GROC is a single-item survey used to evaluate overall recovery from the time that symptoms began until now. Responses are provided on a 15-point Likert scale ranging from "a very great deal worse" to "a very great deal better."

  2. Numeric Rating Scale (NRS)

    Time frame: Three months after the index ED visit.

    The NRS measures intensity of dizziness symptoms from 0 to 10. Participants will report average dizziness intensity over the last 24 hours.

  3. Advanced Healthcare Utilization

    Time frame: Three months after the index ED visit.

    Proportion of participants who utilized any advanced healthcare resources for dizziness after their index ED visit, defined as advanced imaging (e.g., computed tomography, magnetic resonance imaging) or procedures/surgery.

  4. Benzodiazepine Prescription Filling

    Time frame: Three months after the index ED visit

    Benzodiazepine prescription filling data will be queried in the state prescription monitoring database.

  5. Follow-up with Outpatient Physical Therapy

    Time frame: Three months after the index ED visit

    Proportion of participants who reports outpatient physical therapy follow-up for vestibular rehabilitation

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Pilot Feasibility Trial of Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo

Acronym: ED-VeRT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 17, 2021
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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