Effectiveness of an evidence-based care pathway to improve mobility and participation in older patients with vertigo and balance disorders in primary care (MobilE-PHY2): study protocol for a multicentre cluster-randomised controlled trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Caren Horstmannshoff - , Rosenheim University of Applied Sciences (Author)
  • Stefanie Skudlik - , Rosenheim University of Applied Sciences (Author)
  • Jenny Petermann - , Department of internal Medicine III - Division General Medicine (Author)
  • Theresia Kiesel - , Rosenheim University of Applied Sciences (Author)
  • Tobias Döringer - , Rosenheim University of Applied Sciences (Author)
  • Alexander Crispin - , Ludwig Maximilian University of Munich (Author)
  • Joachim Hermsdörfer - , Technical University of Munich (Author)
  • Juliane Köberlein-Neu - , University of Wuppertal (Author)
  • Klaus Jahn - , Ludwig Maximilian University of Munich (Author)
  • Stefan Schädler - , Physiotherapie im Schloss (Author)
  • Petra Bauer - , Rosenheim University of Applied Sciences (Author)
  • Karen Voigt - , Department of internal Medicine III - Division General Medicine (Author)
  • Martin Müller - , Development and Technology Transfer, Rosenheim University of Applied Sciences, Department of Primary Care and Health Services Research, SRH University Heidelberg (Author)

Abstract

BACKGROUND: 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.

METHODS: 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.

DISCUSSION: With our results, we aim to improve evidence-based health care of community-dwelling older people with VDB in primary care.

TRIAL REGISTRATION: DRKS, DRKS00028524 retrospectively registered on March 24, 2022.

Details

Original languageEnglish
Article number91
Pages (from-to)91
JournalTrials
Volume24
Issue number1
Publication statusPublished - 6 Feb 2023
Peer-reviewedYes

External IDs

PubMedCentral PMC9902065
Scopus 85147461182

Keywords

Keywords

  • Humans, Aged, Middle Aged, Dizziness/diagnosis, Quality of Life, Critical Pathways, Fear, Vertigo/diagnosis, Primary Health Care/methods, Evidence-Based Medicine, Randomized Controlled Trials as Topic, Multicenter Studies as Topic