Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00732797 |
| Other study ID # |
PB-PG-0107-12069 |
| Secondary ID |
08/H0504/31 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2008 |
| Est. completion date |
June 2011 |
Study information
| Verified date |
January 2022 |
| Source |
University of Southampton |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
