A Trial of Booklet Based Self Management of Dizziness
| Tracking Information | |||||
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| First Received Date ICMJE | August 7, 2008 | ||||
| Last Updated Date | August 11, 2011 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Self-reported measures of dizziness [ Time Frame: Measured at beseline, 12 weeks and 1 year. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00732797 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Quality of life effects of dizziness [ Time Frame: Measured at baseline, 12 weeks and 1 year. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Quality of life effects of dizziness [ Time Frame: Measued at baseline, 12 weeks and 1 year. ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Trial of Booklet Based Self Management of Dizziness | ||||
| Official Title ICMJE | Evaluation of the Cost-effectiveness of Booklet-based Self-management of Dizziness in Primary Care, With and Without Expert Telephone Support | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Dizziness | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 337 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00732797 | ||||
| Other Study ID Numbers ICMJE | PB-PG-0107-12069, 08/H0504/31 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof Lucy Yardley, University of Southampton | ||||
| Study Sponsor ICMJE | University of Southampton | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Southampton | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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