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A Trial of Booklet Based Self Management of Dizziness

This study has been completed.
Sponsor:
Information provided by:
University of Southampton
ClinicalTrials.gov Identifier:
NCT00732797
First received: August 7, 2008
Last updated: August 11, 2011
Last verified: January 2010

August 7, 2008
August 11, 2011
October 2008
January 2011   (final data collection date for primary outcome measure)
Self-reported measures of dizziness [ Time Frame: Measured at beseline, 12 weeks and 1 year. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00732797 on ClinicalTrials.gov Archive Site
Quality of life effects of dizziness [ Time Frame: Measured at baseline, 12 weeks and 1 year. ] [ Designated as safety issue: No ]
Quality of life effects of dizziness [ Time Frame: Measued at baseline, 12 weeks and 1 year. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial of Booklet Based Self Management of Dizziness
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Dizziness
  • 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
  • No Intervention: Routine Care
    Participants will receive routine care.
  • Active Comparator: Booklet
    Participants will receive self-treatment booklets, but no expert telephone support.
    Intervention: Behavioral: Self-treatment booklet
  • Active Comparator: Booklet &Therapist Support
    Participants will receive self-treatment booklets, and up to an hour's expert telephone support.
    Interventions:
    • Behavioral: Self-treatment booklet
    • Behavioral: Remote telephone support
Yardley L, Barker F, Muller I, Turner D, Kirby S, Mullee M, Morris A, Little P. Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial. BMJ. 2012 Jun 6;344:e2237. doi: 10.1136/bmj.e2237.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
337
June 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00732797
PB-PG-0107-12069, 08/H0504/31
No
Prof Lucy Yardley, University of Southampton
University of Southampton
Not Provided
Principal Investigator: Lucy Yardley University of Sothampton
University of Southampton
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP