A Trial of Booklet Based Self Management of Dizziness
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|ClinicalTrials.gov Identifier: NCT00732797|
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : August 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Dizziness||Behavioral: Self-treatment booklet Behavioral: Remote telephone support||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||337 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of the Cost-effectiveness of Booklet-based Self-management of Dizziness in Primary Care, With and Without Expert Telephone Support|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||June 2011|
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 exercisesBehavioral: Remote telephone support
Up to an hour's remote support from an expert vestibular therapist
- Self-reported measures of dizziness [ Time Frame: Measured at beseline, 12 weeks and 1 year. ]
- Quality of life effects of dizziness [ Time Frame: Measured at baseline, 12 weeks and 1 year. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732797
|Hampshire PCT and Berkshire PCT|
|Southampton, United Kingdom|
|Principal Investigator:||Lucy Yardley||University of Sothampton|