R42 H81 R26 R29.6 F45.8
Conditions
Interventions
Group 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 ste
Sponsors
Technische Hochschule Rosenheim, Fakultät für Angewandte Gesundheits- und Sozialwissenschaften
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 mon | — |
Countries
Germany
Contacts
Public ContactCaren Horstmannshoff
Technische Hochschule Rosenheim
Outcome results
None listed