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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011869
Enrollment
4
Registered
2017-03-29
Start date
2017-04-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H81 R42

Interventions

Group 1: Primary care providers in the intervention arm receive a training of the following modules: (1) generic communication training according to the communication models of Marshall B. Rosenberg a

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Process Objectives: To assess (1) the feasibility of the study procedures and (2) the acceptability of the components of the intervention to the general practitioners and patients. 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

MeasureTime frame
Research Objectives To provide a first estimation of (1) the likely changes in the intervention cluster as compared to the control cluster in terms of functioning, participation and quality of life of patients with vertigo and dizziness (2) clinical disease severity indicators in terms of frequency, duration and quality of vertigo symptoms (3) health care utilisation in terms of number and type of therapeutic and diagnostic measures, time to diagnosis and referral frequencies to specialists. 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.

Countries

Germany

Contacts

Public ContactEva Kovacs

Institut für Medizinische Informationsverarbeitung, Biometrie und EpidemiologieLudwig-Maximilians-Universität München LMU und Deutsches Schwindel- und Gleichgewichtszentrum (DSGZ) Klinikum der Universität München

eva.kovacs@med.uni-munechen.de+49 89 2180 78220

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026