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临床试验/NCT00732797
NCT00732797已完成不适用

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

University of Southampton1 个研究点 分布在 1 个国家目标入组 337 人开始时间: 2008年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
337
试验地点
1
主要终点
Self-reported measures of dizziness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Routine Care

No Intervention

Participants will receive routine care.

Booklet

Active Comparator

Participants will receive self-treatment booklets, but no expert telephone support.

干预措施: Self-treatment booklet (Behavioral)

Booklet &Therapist Support

Active Comparator

Participants will receive self-treatment booklets, and up to an hour's expert telephone support.

干预措施: Self-treatment booklet (Behavioral)

Booklet &Therapist Support

Active Comparator

Participants will receive self-treatment booklets, and up to an hour's expert telephone support.

干预措施: Remote telephone support (Behavioral)

结局指标

主要结局

Self-reported measures of dizziness

时间窗: Measured at beseline, 12 weeks and 1 year.

次要结局

  • Quality of life effects of dizziness(Measured at baseline, 12 weeks and 1 year.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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