Chronic DizzinessNCT04391673
Factors Affecting Outcome of Vestibular Rehabilitation
An observational study of Chronic Dizziness and Vestibular Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Dizziness, Vestibular Disease
- What is being tested?
- Vestibular rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2019to Sep 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dizziness and balance disorders.
Who may be able to join
- are aged above 18 years old and are enrolled onto the vestibular rehabilitation programme due to chronic dizziness
Who cannot join
- Patients will be excluded if they have evidence of central nervous system disorders or cannot speak English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
About this study
Official title: Analysis of Illness Perceptions Affecting the Outcome of Vestibular Rehabilitation
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.
Read the detailed description
The aim of this longitudinal study is to investigate whether illness perceptions predict dizziness handicap following a treatment as usual 8-week vestibular rehabilitation programme in patients with chronic vertigo and dizziness.
Participants will be recruited consecutively from patients attending the dizziness and balance exercise programme at Guys \& St Thomas' NHS Foundation Trust. Consenting patients will complete the following questionnaires before and after rehabilitation:
- The Dizziness Handicap Inventory (DHI)
- The Illness Perceptions Questionnaire - Revised (IPQ-R)
- The Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
The Dizziness Handicap Inventory (DHI) at discharge will be the dependent variable. We will also demographic data including age, gender, and illness type.
- Conditions
- Chronic Dizziness, Vestibular Disease
- Being tested
- Vestibular rehabilitation
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitationBehavioural
Vestibular rehabilitation (treatment as usual).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At discharge (final session of physiotherapy), an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start26 Sep 2019
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Chief Investigator Moved Hospitals Before the Trial Began. Was discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Herdman, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391673
- Sponsor's protocol ID
- 269318
- Status last verified
- Mar 2022
- First submitted
- 5 Feb 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided