Pilot cluster randomized controlled trial of a multifactorial intervention to improve management of vertigo in primary care

Not Applicable

• Conditions: H81; R42; Disorders of vestibular function; Dizziness and giddiness

• Registration Number: DRKS00011869
• Lead Sponsor: Institut für Medizinische Informationsverarbeitung, Biometrie und EpidemiologieLudwig-Maximilians-Universität München LMU und Deutsches Schwindel- und Gleichgewichtszentrum (DSGZ) Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-29
• Study Completion: 2019-02-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

PCPs will include the following patients (96 patients planned): the main reason for consultation is having any kind of undiagnosed symptom of moderate to severe vertigo or dizziness (whether new or already present),

sufficient command of German language,

statutory health insurance,

signed written informed consent

Exclusion Criteria

PCPs will exclude the following patients: relevant cognitive impairment (equivalent to a Mini Mental State Exam score of 27 or below, judged by the general practitioner),
terminal disease,
known unavailability in the scheduled follow-up time interval

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Process Objectives:<br>To assess <br>(1) the feasibility of the study procedures and <br>(2) the acceptability of the components of the intervention to the general practitioners and patients. <br>This will be assessed by questionnaire (training of the general practitioners) and a structured interview will take place after the follow-up period (after 3 months) (both the general practitioners and patients).

Secondary Outcome Measures

Name	Time	Method
Research Objectives <br>To provide a first estimation of<br>(1) the likely changes in the intervention cluster as compared to the control cluster in terms of <br>functioning, participation and quality of life of patients with vertigo and dizziness <br>(2) clinical disease severity indicators in terms of frequency, duration and quality of vertigo symptoms<br>(3) health care utilisation in terms of number and type of therapeutic and diagnostic measures, time to diagnosis and referral frequencies to specialists.<br><br>Research objectives will be assessed at the baseline and follow-up 3 months later by standardised (VAP-e, DHI, EQ-5D, QCPC) and study-specific questionnaires.