A Trial of Booklet Based Self Management of Dizziness
Primary Purpose
Dizziness
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self-treatment booklet
Remote telephone support
Sponsored by
About this trial
This is an interventional treatment trial for Dizziness focused on measuring Dizziness, Self-management, booklet-based, vestibular rehabilitation
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.
Sites / Locations
- Hampshire PCT and Berkshire PCT
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Routine Care
Booklet
Booklet &Therapist Support
Arm Description
Participants will receive routine care.
Participants will receive self-treatment booklets, but no expert telephone support.
Participants will receive self-treatment booklets, and up to an hour's expert telephone support.
Outcomes
Primary Outcome Measures
Self-reported measures of dizziness
Secondary Outcome Measures
Quality of life effects of dizziness
Full Information
NCT ID
NCT00732797
First Posted
August 7, 2008
Last Updated
January 3, 2022
Sponsor
University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT00732797
Brief Title
A Trial of Booklet Based Self Management of Dizziness
Official Title
Evaluation of the Cost-effectiveness of Booklet-based Self-management of Dizziness in Primary Care, With and Without Expert Telephone Support
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness
Keywords
Dizziness, Self-management, booklet-based, vestibular rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
337 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
Participants will receive routine care.
Arm Title
Booklet
Arm Type
Active Comparator
Arm Description
Participants will receive self-treatment booklets, but no expert telephone support.
Arm Title
Booklet &Therapist Support
Arm Type
Active Comparator
Arm Description
Participants will receive self-treatment booklets, and up to an hour's expert telephone support.
Intervention Type
Behavioral
Intervention Name(s)
Self-treatment booklet
Intervention Description
A booklet outlining vestibular rehabilitation exercises
Intervention Type
Behavioral
Intervention Name(s)
Remote telephone support
Intervention Description
Up to an hour's remote support from an expert vestibular therapist
Primary Outcome Measure Information:
Title
Self-reported measures of dizziness
Time Frame
Measured at beseline, 12 weeks and 1 year.
Secondary Outcome Measure Information:
Title
Quality of life effects of dizziness
Time Frame
Measured at baseline, 12 weeks and 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Yardley
Organizational Affiliation
University of Sothampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hampshire PCT and Berkshire PCT
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25986639
Citation
Muller I, Kirby S, Yardley L. Understanding patient experiences of self-managing chronic dizziness: a qualitative study of booklet-based vestibular rehabilitation, with or without remote support. BMJ Open. 2015 May 18;5(5):e007680. doi: 10.1136/bmjopen-2015-007680.
Results Reference
derived
PubMed Identifier
22674920
Citation
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.
Results Reference
derived
PubMed Identifier
20098640
Citation
Yardley L, Kirby S, Barker F, Little P, Raftery J, King D, Morris A, Mullee M. An evaluation of the cost-effectiveness of booklet-based self-management of dizziness in primary care, with and without expert telephone support. BMC Ear Nose Throat Disord. 2009 Dec 29;9:13. doi: 10.1186/1472-6815-9-13.
Results Reference
derived
Learn more about this trial
A Trial of Booklet Based Self Management of Dizziness
We'll reach out to this number within 24 hrs