NCT05122663

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

November 12, 2021

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dizziness Handicap Inventory (DHI)

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

    Three months after the index ED visit.

Secondary Outcomes (4)

  • Vestibular Activities Avoidance Instrument (VAAI-9)

    Three months after the index ED visit.

  • ED Diagnostic Imaging Utilization

    Index ED visit (one day)

  • ED Length of Stay

    Index ED visit (up to one week)

  • Patient-Reported Medication Use in Last 24 Hours

    Three months after the index ED visit.

Other Outcomes (5)

  • Global Rating of Change (GROC)

    Three months after the index ED visit.

  • Numeric Rating Scale (NRS)

    Three months after the index ED visit.

  • Advanced Healthcare Utilization

    Three months after the index ED visit.

  • +2 more other outcomes

Study Arms (2)

ED Physical Therapy

Patients in the ED physical therapy group will have been evaluated by an emergency department physical therapist for dizziness/vertigo during their index ED visit.

Behavioral: Vestibular Rehabilitation

Usual Care

Patients in the usual care group will NOT have received an evaluation by an ED physical therapist for dizziness/vertigo symptoms during their index ED visit.

Other: Usual Care

Interventions

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.

ED Physical Therapy

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

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ED patients presenting with a chief complaint relating to dizziness or vertigo.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Kim HS, Schauer JM, Kan AK, Alinger JB, Strickland KJ, Garreau A, McCarthy DM, Taylor ZB, Fishman IL, Muschong KM, Roth HR. Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459567. doi: 10.1001/jamanetworkopen.2024.59567.

MeSH Terms

Conditions

DizzinessVertigo

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 17, 2021

Study Start

November 16, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations