NCT04391673

Brief Summary

This is an observational longitudinal study to investigate if negative illness perceptions predict less improvement in dizziness handicap following vestibular rehabilitation. Consecutive patients (n=260) who enter the vestibular rehabilitation programme at Guy's Hospital, London will be included. Questionnaires will be conducted immediately before, and after their final treatment. The main outcome will be the Dizziness Handicap Inventory after rehabilitation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

February 5, 2020

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dizziness Handicap Inventory (DHI)

    DHI at discharge (controlling for baseline DHI in the final analysis). The DHI measures the perceived physically, functionally, and emotionally handicapping effects of dizziness although the total score will be used in this study. It consists of 25 questions, for example "Does walking down the aisle of a supermarket increase your problem?", and participants rate either 'Yes', 'No', or 'Sometimes'. The maximum score is 100 and higher scores represent higher levels of disability and activity restriction.

    At discharge (final session of physiotherapy), an average of 10 weeks

Study Arms (1)

Dizzy group

Patients attending the dizziness and balance exercise programme at Guy's Hospital, London. Patients data will be included if they complete at least 4 sessions.

Behavioral: Vestibular rehabilitation

Interventions

Vestibular rehabilitation (treatment as usual).

Dizzy group

Eligibility Criteria

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

Patients with dizziness and balance disorders.

You may qualify if:

  • are aged above 18 years old and are enrolled onto the vestibular rehabilitation programme due to chronic dizziness

You may not qualify if:

  • Patients will be excluded if they have evidence of central nervous system disorders or cannot speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • David Herdman

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

May 18, 2020

Study Start

September 26, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations