Yardley Lucy, Kirby Sarah, Barker Fiona, Little Paul, Raftery James, King Debbie, Morris Anna, Mullee Mark
School of Psychology, University of Southampton, Highfield, Southampton, UK.
BMC Ear Nose Throat Disord. 2009 Dec 29;9:13. doi: 10.1186/1472-6815-9-13.
Dizziness is a very common symptom that often leads to reduced quality of life, anxiety and emotional distress, loss of fitness, lack of confidence in balance, unsteadiness and an increased risk of falling. Most dizzy patients are managed in primary care by reassurance and medication to suppress symptoms. Trials have shown that chronic dizziness can be treated effectively in primary care using a self-help booklet to teach patients vestibular rehabilitation exercises that promote neurological adaptation and skill and confidence in balance. 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. The aim of this trial is to evaluate two new alternative models of delivery that may be more feasible and cost-effective.
METHODS/DESIGN: In a single blind two-centre pragmatic controlled trial, we will randomise 330 patients from 30 practices to a) self-help booklet with telephone support from a vestibular therapist, b) self-help booklet alone, c) routine medical care. Symptoms, disability, handicap and quality of life will be assessed by validated questionnaires administered by post at baseline, immediately post-treatment (3 months), and at one year follow-up. The study is powered to test our primary hypothesis, that the self-help booklet with telephone support will be more effective than routine care. We will also explore the effectiveness of the booklet without any support, and calculate the costs of treatment in each arm.
If our trial indicates that patients can cost-effectively manage their dizziness in primary care, then it can be easily rolled out to relieve the symptoms of the many patients in primary care who currently have chronic, untreated, disabling dizziness. Treatment in primary care may reduce the development of psychological and physical sequelae that cause handicap and require treatment. There is also the potential to reduce the cost to the NHS of treating dizziness by reducing demand for referral to secondary care for specialist assessment and treatment.
ClinicalTrials.gov trial registration ID number: NCT00732797.
头晕是一种非常常见的症状,常常导致生活质量下降、焦虑和情绪困扰、身体不适、平衡信心丧失、步态不稳以及跌倒风险增加。大多数头晕患者在初级保健机构接受治疗,主要方式是给予安慰和使用药物来抑制症状。试验表明,在初级保健中,使用一本自助手册来教授患者进行前庭康复训练,促进神经适应以及平衡技能和信心,可以有效治疗慢性头晕。然而,这些试验中提供了来自经过培训的护士的简短支持,由于初级保健机构缺乏技能和资源,这种管理头晕患者的模式尚未得到推广。本试验的目的是评估两种新的替代实施模式,这两种模式可能更可行且更具成本效益。
方法/设计:在一项单盲双中心实用对照试验中,我们将把来自30家医疗机构的330名患者随机分为三组:a)使用自助手册并接受前庭治疗师的电话支持;b)仅使用自助手册;c)常规医疗护理。症状、残疾程度、功能障碍和生活质量将通过在基线、治疗后立即(3个月)以及一年随访时邮寄的经过验证的问卷进行评估。该研究有足够的效力来检验我们的主要假设,即使用电话支持的自助手册比常规护理更有效。我们还将探讨没有任何支持的手册的有效性,并计算每组治疗的成本。
如果我们的试验表明患者能够在初级保健中以具有成本效益的方式管理他们的头晕,那么就可以很容易地推广,以缓解目前在初级保健中许多患有慢性、未治疗、致残性头晕的患者的症状。在初级保健中进行治疗可能会减少导致功能障碍并需要治疗的心理和身体后遗症的发生。此外,通过减少转诊至二级保健机构进行专科评估和治疗的需求,还有可能降低英国国家医疗服务体系(NHS)治疗头晕的成本。
ClinicalTrials.gov试验注册ID编号:NCT00732797。