Stam Hanneke, van der Wouden Johannes C, van der Horst Henriëtte E, Maarsingh Otto R
Department of General Practice and Elderly Care Medicine and EMGO Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, room D550, 1081 BT, Amsterdam, The Netherlands.
Trials. 2015 Jul 25;16:313. doi: 10.1186/s13063-015-0848-1.
The management of dizziness in older patients is primarily diagnosis-oriented. However, in 40% of older patients with dizziness, GPs are not able to identify an underlying cause, and a number of common underlying causes of dizziness cannot (or hardly) be treated. In this study we will investigate the effectiveness of a prognosis-oriented approach in the management of dizziness in older patients. This prognosis-oriented approach comprises identification of patients at risk for chronic dizziness with persistent impairment by identifying risk factors for an unfavourable course of dizziness. Patients at risk for chronic dizziness with persistent impairment will be offered treatment addressing the identified modifiable risk factors.
METHODS/DESIGN: This study will be performed in primary care. An intervention study and a validation study will be conducted in a three-arm cluster randomised design. In the intervention study we will investigate a risk factor guided multi-component intervention. The risk factor guided intervention includes: (1) medication adjustment in case of three or more prescribed fall-risk-increasing drugs, (2) stepped care in case of anxiety disorder and/or depression, and (3) exercise therapy in case of impaired functional mobility. The primary outcome measure is dizziness-related impairment, which will be assessed with the Dizziness Handicap Inventory. Secondary outcome measures are quality of life, anxiety disorder and depression, use of fall-risk-increasing drugs, dizziness frequency, fall frequency, and healthcare utilization.
This study is, to date, the first study that will investigate the effectiveness of a prognosis-oriented approach for reducing dizziness-related impairment in older people in primary care. Offering treatment that addresses identified modifiable risk factors to patients at high risk for chronic dizziness is unique. The pragmatic design of this study will enable evaluation of the outcomes in real-life routine practice conditions. An effective intervention will not only reduce dizziness-related impairment, but may also decrease healthcare utilization and healthcare costs. The previously developed risk score that will be validated alongside the intervention study will enable GPs to identify patients at high risk for chronic dizziness with persistent impairment.
Netherlands Trial Register (identifier: NTR4346), registration date 15 December 2013.
老年患者头晕的管理主要以诊断为导向。然而,在40%的老年头晕患者中,全科医生无法确定潜在病因,且一些常见的头晕潜在病因无法(或几乎无法)得到治疗。在本研究中,我们将调查以预后为导向的方法在老年患者头晕管理中的有效性。这种以预后为导向的方法包括通过识别头晕不良病程的风险因素,来确定有慢性头晕且持续受损风险的患者。对于有慢性头晕且持续受损风险的患者,将提供针对已确定的可改变风险因素的治疗。
方法/设计:本研究将在初级保健机构开展。将采用三臂整群随机设计进行一项干预研究和一项验证研究。在干预研究中,我们将调查一种风险因素导向的多成分干预措施。风险因素导向干预包括:(1)如果开具了三种或更多增加跌倒风险的药物,则调整用药;(2)如果患有焦虑症和/或抑郁症,则采用逐步护理;(3)如果功能活动受损,则进行运动疗法。主要结局指标是头晕相关损害,将使用头晕残障量表进行评估。次要结局指标包括生活质量、焦虑症和抑郁症、增加跌倒风险药物的使用、头晕频率、跌倒频率以及医疗保健利用情况。
迄今为止,本研究是第一项调查以预后为导向的方法在初级保健中减少老年人头晕相关损害有效性的研究。为慢性头晕高风险患者提供针对已确定的可改变风险因素的治疗是独一无二的。本研究的实用设计将能够在实际日常实践条件下评估结局。有效的干预措施不仅会减少头晕相关损害,还可能降低医疗保健利用和医疗成本。与干预研究同时进行验证的先前开发的风险评分,将使全科医生能够识别有慢性头晕且持续受损高风险的患者。
荷兰试验注册库(标识符:NTR4346),注册日期2013年12月15日。