A Trial of Booklet Based Self Management of Dizziness

January 3, 2022 updated by: University of Southampton

Evaluation of the Cost-effectiveness of Booklet-based Self-management of Dizziness in Primary Care, With and Without Expert Telephone Support

The investigators primary aim is to test whether or not provision of the self-help booklet teaching VR exercises, with up to one hour of telephone support from a vestibular therapist, will be more effective than routine care in reducing symptoms in dizzy patients in primary care. The investigators will also explore the extent to which patients may benefit from the self-help booklet without support. The investigators will determine whether these models of delivery are less costly than routine care of dizzy patients, as they should reduce the number of patients seeking referral to secondary care for unnecessary assessments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic dizziness has a prevalence of up to 25% in the community, and 1 in 10 working age adults and 1 in 5 older people report some degree of handicap due to dizziness. Dizziness can lead to reduced quality of life, anxiety and emotional distress, loss of fitness, unsteadiness and vulnerability to falling. Reviews of the management of dizziness have concluded that no medication has well-established value or is suitable for long-term use, and vestibular rehabilitation (VR) is now recommended as the treatment of choice. Professor Lucy Yardley has carried out trials showing that chronic dizziness can be treated effectively using a self-help booklet to teach patients vestibular rehabilitation exercises that promote neurological adaptation and skill and confidence in balance. These exercises are carried out for 10 minutes twice daily at home, and involve gently increasing the speed of making normal head movements. However, brief support from a trained nurse was provided in these trials, and this model of managing dizzy patients has not been taken up due to a lack of skills and resources in primary care.

We have received funding to evaluate the cost-effectiveness of two new models of delivery of vestibular rehabilitation. Our primary aim is to test the hypothesis that provision of the self-help booklet teaching vestibular rehabilitation exercises, with up to one hour of remote telephone support from an expert vestibular therapist, will be more effective than routine care in reducing symptoms (and therefore also disability and handicap) in dizzy patients in primary care. We will also explore the extent to which patients may benefit from provision of the self-help booklet without support. We will determine whether these models of delivery are less costly than routine care of dizzy patients, as they should reduce the number of patients seeking referral to secondary care for unnecessary assessments.

This trial involves patients taking part in either a 12 week self-treatment programme (with or without telephone support from an expert vestibular therapist) or routine care, and completing questionnaires before and after the self-treatment, and also one year later. We will recruit 330 participants with dizziness who are registered with 30 general practices around Southampton and Berkshire. The trial will be carried out approximately between June 2008 and June 2011.

Study Type

Interventional

Enrollment (Actual)

337

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Southampton, United Kingdom
        • Hampshire PCT and Berkshire PCT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be 18 years or over
  • Be registered with a participating GP
  • Must have visited their GP for dizziness in the last 2 years
  • Must complete the consent form, and baseline questionaire indicating they are still suffering from dizziness and that quick head movements make them dizzy.

Exclusion Criteria:

  • Non-Labyrinthe cause of dizziness identified by GP
  • Medical contraindications from making normal head movements
  • Serious co-morbidity
  • Moved away from practice
  • Recently deceased
  • Non-English speakers, and unable to read/write in English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Routine Care
Participants will receive routine care.
ACTIVE_COMPARATOR: Booklet
Participants will receive self-treatment booklets, but no expert telephone support.
Behavioral: Self-treatment booklet
A booklet outlining vestibular rehabilitation exercises
ACTIVE_COMPARATOR: Booklet &Therapist Support
Participants will receive self-treatment booklets, and up to an hour's expert telephone support.
Behavioral: Self-treatment booklet
A booklet outlining vestibular rehabilitation exercises
Behavioral: Remote telephone support
Up to an hour's remote support from an expert vestibular therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported measures of dizziness
Time Frame: Measured at beseline, 12 weeks and 1 year.
Measured at beseline, 12 weeks and 1 year.

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life effects of dizziness
Time Frame: Measured at baseline, 12 weeks and 1 year.
Measured at baseline, 12 weeks and 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Investigators

  • Principal Investigator: Lucy Yardley, University of Sothampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (ESTIMATE)

August 12, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB-PG-0107-12069
  • 08/H0504/31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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