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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): A multicentre cluster-randomised controlled trial

Organizational Data

DRKS-ID:
DRKS00028524
Recruitment Status:
Enrolling by invitation
Date of registration in DRKS:
2022-03-24
Last update in DRKS:
2023-07-04
Registration type:
Retrospective

Acronym/abbreviation of the study

MobilE-PHY2

URL of the study

https://projekte.th-rosenheim.de/forschungsprojekt/536-mobile-net

Brief summary in lay language

The aim of MobilE-PHY2 is to determine the effectiveness of an evidence-based care pathway in the GP setting with regard to improve mobility and participation of older people with dizziness and/or balance disorders. The project is accompanied by a comprehensive process evaluation that examines the change process among patients and stakeholders in primary care. A health economic evaluation will determine the cost-effectiveness.

Brief summary in scientific language

Background Vertigo, dizziness or balance disorders (VDB) are common leading symptoms in older people, which can have an negative impact on their mobility and participation in daily live, yet, diagnosis is challenging and specific treatment is often insufficient. An evidence-based 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 of the multidisciplinary 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, 12 general practitioner's practices, which act as clusters, will be recruited in two regions of Germany. A total of 120 patients over 60 years old with VDB will be included. To compare the effect of the CPW with optimised usual care (usual care and an information session for General practitioners (GP), randomisation to intervention and control group will take place at cluster level. The intervention is an algorithmized CPW that illustrates all steps of the patient pathway. The GP receives a standardised checklist for diagnostic screening. Physiotherapists (PT) receive a decision tree for evidence-based physiotherapeutic clinical reasoning and treatment of VDB. The implementation strategy comprises educational trainings as well as a workshop for the GP and PT practices, an information session for outpatient nurses, a pocket card for outpatient nurses and informal caregivers and telephone peer counselling. GPs of the control group get an information session addressing the national guideline. The primary outcome is the impact of VDB on participation and mobility of patients after six month follow-up, assessed using the Dizziness Handicap Inventory (DHI) questionnaire. Secondary outcomes are daily-life physical activity profile, 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. The study will be accompanied by a comprehensive mixed-method process evaluation. Discussion With our results we hope to contribute to an improved care of community-dwelling older people with VDB in primary care

Health condition or problem studied

ICD10:
R42 - Dizziness and giddiness
ICD10:
H81 - Disorders of vestibular function
ICD10:
R26 - Abnormalities of gait and mobility
ICD10:
R29.6 - Tendency to fall, not elsewhere classified
ICD10:
F45.8 - Other somatoform disorders
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
The intervention is an algorithmized evidence-based CPW to enhance the care of older persons with VDB and thus promote their mobility and participation in daily living. It illustrates all steps of the patient pathway through a standardised approach which consists of two main components: (1) A paper-based decision aid for classifying diagnosis of patients with VDB and that guide the further procedure applied by previously trained GPs. It contains evidence-based diagnostics, treatment and referral options for the whole treatment period. (2) A decision tree for evidence-based physiotherapeutic clinical reasoning and treatment of VDB applied by previously trained PTs. It consists of recommendations or options for anamnesis (including information about clinical pattern), specific assessments, treatment and evaluation. The decision tree is only applied, if the treating GP prescribes physiotherapy.
Arm 2:
Optimised usual care refers to usual care based on the on the guideline of the German College of General Practitioners and Family Physicians (DEGAM) “acute dizziness” for GPs. All GPs in the control group receive a 40-minutes refresher training on the guideline.

Endpoints

Primary outcome:
The primary outcome is the impact of VDB on participation and mobility of patients after six month follow-up, assessed using the Dizziness Handicap Inventory (DHI). The primary outcome will be assessed on patient level in the intervention group and control group at three measurement points: At baseline after randomisation (t0), after four months (t1) and after six months (t2).
Secondary outcome:
Secondary outcomes are daily-life physical activity profile, static and dynamic balance, falls and fear of falling as well as quality of life. We will also evaluate health economic aspects of the intervention. The main secondary outcome is the qualitative and quantitative daily-life physical activity. For objective measurement of the change we will use wearable sensor-based actigraphy with the move 3 and 4 device from movisens (https://www.movisens.com/de/produkte/aktivitaetssensor/). In addition, patients will receive and fill a physical activity diary with information about activities and occurrence of VDB. The incidence of falls during the intervention period as main safety outcome will be documented by the physical activity diary. In addition, the falls within the last six months before the start of the intervention are assessed. We will examine concerns about falling and the psychological consequences of falling using the Falls Efficacy Scale-International Version, which consists of 16 items. We will investigate static and dynamic balance by using the validated German Version of the Mini-Balance Evaluation Systems Test. It has four domains: anticipatory proactive balance, reactive postural control, sensory orientation and dynamic gait and 14 items. The health-related quality of life will be assessed by the German version of the European Quality of Life Five-Dimension Five-Level Scale. The five dimensions are mobility, self-care, usual activities, pain/ discomfort as well as anxiety/ depression. Healthcare resource utilisation and medication will be assessed using the validated “Questionnaire for Health-Related Resource Use in an Elderly Population” (Fragebogen zur Inanspruchnahme Medizinischer und nicht-medizinischer Versorgungsleistungen im Alter). It consists of 14 items. The secondary outcomes will be assessed on patient level in the intervention group and control group at three measurement points: At baseline after randomisation (t0), after four months (t1) and after six months (t2). Additional data on cluster, PT and outpatient nursing service level will be assessed at t0

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Assessor
  • Caregiver
  • Data analyst
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Enrolling by invitation
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Medizinische Fakultät Carl Gustav Carus der Technischen Universität Dresden, Bereich Allgemeinmedizin Dresden
  • Other Technische Hochschule Rosenheim Rosenheim

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2021-12-21
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
120
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
60 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- At least 60 years old - Consulted GP with recent or chronic complaints of VDB - Ability to stand up on their own - Ability to stand for two minutes with support

Exclusion Criteria

- DHI score less than 12 points - Moderate to severe cognitive impairments measured by the Mini-Mental State Examination (MMST) with an cut off less than 20 points - Presence of psychiatric disorders (ICD-10: F10, F19, F20, F29, F30, F31, F32.2, F32.3, F32.8, F32.9, F33.2, F33.3, F33.8, F33.9) - Limited life expectancy (≤ 1 year) due to an advanced disease with a poor prognosis - VDB caused by actual substance abuse - Inability to complete questionnaires and follow instructions because of insufficient command of the German language

Addresses

Primary Sponsor

Technische Hochschule Rosenheim, Fakultät für Angewandte Gesundheits- und Sozialwissenschaften
Prof. Dr. Martin Müller
Hochschulstr. 1
83024 Rosenheim
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Technische Hochschule Rosenheim, Fakultät für Angewandte Gesundheits- und Sozialwissenschaften
Prof. Dr. Martin Müller
Hochschulstr. 1
83024 Rosenheim
Germany
Telephone:
+49 (0)8031 805 -2541
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Technische Hochschule Rosenheim
Caren Horstmannshoff
Hochschulstr. 1
83024 Rosenheim
Germany
Telephone:
+49 (0)8031 805 - 2999
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Technische Hochschule Rosenheim, Fakultät für Angewandte Gesundheits- und Sozialwissenschaften
Prof. Dr. Martin Müller
Hochschulstr. 1
83024 Rosenheim
Germany
Telephone:
+49 (0)8031 805 -2541
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Friedrichstraße 130 B
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-07-02
Ethics committee number:
21-0719
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-08-18

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
/

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry