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
  Purpose

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.


Condition Intervention Phase
Dizziness
Behavioral: Self-treatment booklet
Behavioral: Remote telephone support
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Cost-effectiveness of Booklet-based Self-management of Dizziness in Primary Care, With and Without Expert Telephone Support

Resource links provided by NLM:


Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • Self-reported measures of dizziness [ Time Frame: Measured at beseline, 12 weeks and 1 year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life effects of dizziness [ Time Frame: Measured at baseline, 12 weeks and 1 year. ] [ Designated as safety issue: No ]

Enrollment: 337
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732797

Locations
United Kingdom
Hampshire PCT and Berkshire PCT
Southampton, United Kingdom
Sponsors and Collaborators
University of Southampton
Investigators
Principal Investigator: Lucy Yardley University of Sothampton
  More Information

No publications provided by University of Southampton

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Lucy Yardley, University of Southampton
ClinicalTrials.gov Identifier: NCT00732797     History of Changes
Other Study ID Numbers: PB-PG-0107-12069, 08/H0504/31
Study First Received: August 7, 2008
Last Updated: August 11, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Southampton:
Dizziness
Self-management
booklet-based
vestibular rehabilitation

Additional relevant MeSH terms:
Dizziness
Vertigo
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014