Centre for Research, Development and Technology Transfer, Rosenheim Technical University of Applied Sciences, Hochschulstr. 1, 83024, Rosenheim, Germany.
Department of Sport and Health Sciences, Chair of Human Movement Science, Technical University of Munich, Georg-Brauchle-Ring 60/62, 80992, Munich, Germany.
Trials. 2023 Feb 6;24(1):91. doi: 10.1186/s13063-022-07017-x.
Vertigo, dizziness or balance disorders (VDB) are common leading symptoms in older people, which can have a negative impact on their mobility and participation in daily live, yet, diagnosis is challenging and specific treatment is often insufficient. An evidence-based, multidisciplinary care pathway (CPW) in primary care was developed and pilot tested in a previous study. The aim of the present study is to evaluate the effectiveness and safety of the CPW in terms of improving mobility and participation in community-dwelling older people with VDB in primary care.
For this multicentre cluster randomised controlled clinic trial, general practitioners (GP) will be recruited in two regions of Germany. A total of 120 patients over 60 years old with VDB will be included. The intervention is an algorithmized CPW. GPs receive a checklist for standardise clinical decision making regarding diagnostic screening and treatment of VDB. Physiotherapists (PT) receive a decision tree for evidence-based physiotherapeutic clinical reasoning and treatment of VDB. Implementation strategies comprises educational trainings as well as a workshop to give a platform for exchange for the GPs and PTs, an information meeting and a pocket card for home care nurses and informal caregivers and telephone peer counselling to give all participants the capability, opportunity and the motivation to apply the intervention. In order to ensure an optimised usual care in the control group, GPs get an information meeting addressing the national guideline. The primary outcome is the impact of VDB on participation and mobility of patients after 6 month follow-up, assessed using the Dizziness Handicap Inventory (DHI) questionnaire. Secondary outcomes are physical activity, static and dynamic balance, falls and fear of falling as well as quality of life. We will also evaluate safety and health economic aspects of the intervention. Behavioural changes of the participants as well as barriers, facilitating factors and mechanisms of impact of the implementation will be investigated with a comprehensive process evaluation in a mixed-methods design.
With our results, we aim to improve evidence-based health care of community-dwelling older people with VDB in primary care.
DRKS, DRKS00028524 retrospectively registered on March 24, 2022.
眩晕、头晕或平衡障碍（VDB）是老年人常见的主要症状，这些症状会对他们的活动能力和参与日常生活造成负面影响，但诊断具有挑战性，且特定治疗通常不足。在之前的研究中，已开发并试点测试了初级保健中基于循证的多学科护理途径（CPW）。本研究的目的是评估 CPW 在改善初级保健中患有 VDB 的社区居住的老年人的活动能力和参与度方面的有效性和安全性。
在这项多中心集群随机对照临床试验中，将在德国的两个地区招募全科医生（GP）。总共将纳入 120 名 60 岁以上的 VDB 患者。干预措施是一个算法化的 CPW。GP 会收到一份清单，用于对 VDB 的诊断筛查和治疗进行标准化临床决策。物理治疗师（PT）会收到一个决策树，用于基于证据的物理治疗临床推理和 VDB 的治疗。实施策略包括教育培训以及为 GP 和 PT 提供交流平台的研讨会、信息会议和家庭护理护士和非正式照顾者的袖珍卡，以及为所有参与者提供电话同行咨询，以使其有能力、机会和动力来应用干预措施。为了确保对照组中得到优化的常规护理，GP 将参加一次信息会议，该会议将针对国家指南进行。主要结果是在 6 个月随访后，使用头晕残疾问卷（DHI）评估 VDB 对患者参与和活动能力的影响。次要结果是身体活动、静态和动态平衡、跌倒和跌倒恐惧以及生活质量。我们还将评估干预措施的安全性和健康经济学方面。参与者的行为变化以及实施的障碍、促进因素和影响机制将通过混合方法设计的全面过程评估进行调查。
我们的研究旨在提高初级保健中患有 VDB 的社区居住的老年人的循证保健。
DRKS，DRKS00028524 于 2022 年 3 月 24 日进行了回顾性注册。
