A Trial of Booklet Based Self Management of Dizziness

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Dizziness

Intervention / Treatment
-----------------
* Behavioral: Self-treatment booklet
* Behavioral: Remote telephone support


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dizziness, Self-management, booklet-based, vestibular rehabilitation