Trial document




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  DRKS00011869

Trial Description

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Title

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

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Trial Acronym

Prima-Vertigo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Background
Vertigo and dizziness belong to the most common reasons why patients visit their family doctor. Although there are good diagnostic measures for most diseases that may cause vertigo or dizziness, sometimes under- and misdiagnosis may occur. Therefore, it is important to transfer the knowledge and experience of specialized dizziness- and balance clinics to the everyday work of the family doctors.
With the help of trainings and intensive exchanges with the family doctors, we want to contribute to the care and management of vertigo patients, to improve their ability of functioning and their quality of life. During our earlier projects we have identified the demands of the family doctors for having a better exchange between the science and their practical work.
Objectives
The main objective of our pilot study is to provide better care for patients with dizziness and vertigo, as a result of the training of the family doctors. Results of this pilot study, will enable us to better plan any future studies in this area and to find out whether our project shows to be promising even in a significantly larger study.
The study participants are patients with newly developed or existing but undiagnosed vertigo or dizziness symptoms and their family doctors. Initially, the family doctors will participate in a communication training.
Afterwards, half of the physicians will receive a more detailed training including physiotherapy and tips for faster and, above all, more precise diagnostics. On the basis of feedback from the patients, we will analyze what the benefits of such a more detailed training for dizziness patients are.
Expected Results
The study will provide valuable information regarding the efficacy of a vertigo-specific training of the family doctors to improve the quality of life and functioning of the affected patients. In addition, the acceptance of such training for the family doctors and the patients will be assessed.

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Brief Summary in Scientific Language

Background
Vertigo and dizziness belong to the most frequent symptoms in outpatient practices. Although there are effective diagnostic options for most disorders that may cause vertigo and dizziness, under- and misdiagnosis are frequent in primary care. Thus, knowledge and practice of specialized dedicated dizziness and balance clinics has to be transferred to primary care. We hypothesize that a complex intervention on the primary care provider (PCP) level will improve functioning and quality of life of patients with vertigo and dizziness. A thorough need assessment from the perspective of the PCPs has been performed in our previous projects.
Objectives
The main objective of this study is to implement an evidence-based complex intervention for primary care providers in a pilot study and to examine whether the intervention is feasible and sufficiently promising to warrant a larger trial.
Methods
We plan to perform a pragmatic cluster-randomized controlled pilot study, with PCPs as the cluster units of randomisation and patients as the units of analysis. Patients who consult the PCP because of newly developed or existing yet undiagnosed vertigo or dizziness symptoms will be included at patient level. Intervention will be a complex training targeted at the PCPs at cluster level. To balance the influence of non-specific effects all clusters will receive a generic communication training prior to allocation. Allocation to intervention or control will be concealed at the level of clusters (PCPs) and at the level of patients. Patients will be included consecutively.
Expected Results
This study will provide results on the acceptability of the intervention components to PCPs and patients, the feasibility of the planned recruitment process and likely effectiveness of the intervention with regard to improvement of patient-reported outcomes such as quality of life, functioning and participation. The process evaluation aims to identify effects of the complex intervention on the level of both the PCP and the patient.

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Organizational Data

  •   DRKS00011869
  •   2017/03/29
  •   [---]*
  •   yes
  •   Approved
  •   709-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H81 -  Disorders of vestibular function
  •   R42 -  Dizziness and giddiness
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Interventions/Observational Groups

  •   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 and Thomas Gordon.
    (2) vertigo-related training,
    - Key aspects of evidence-based procedures on acute dizziness in family practice
    - Taking case history of vertigo patients
    -Practical training for certain diagnostic tests and therapeutic exoneration maneuvers

    The following intervention materials will be introduced:
    - a patient-mediated structured case history referral slip which serves as a reminder, fast marking of the findings, easy exchange of the findings with other doctors, presentation of the current state of the diagnosis.
    - distribution of patient information materials according to the diagnosis
  •   Primary care providers in the control arm receive generic communication training according to the communication models of Marshall B. Rosenberg and Thomas Gordon. In the following they continue their usual care of the vertigo patients
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, data analyst
  •   Active control (effective treament of control group)
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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).

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/04/06
  •   4
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Institut für Medizinische Informationsverarbeitung, Biometrie und EpidemiologieLudwig-Maximilians-Universität München LMU und Deutsches Schwindel- und Gleichgewichtszentrum (DSGZ) Klinikum der Universität München
    • Ms.  Prof. Dr., MPH  Eva  Grill 
    • Marchinonistr. 17
    • 81377  München
    • Germany
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    • Institut für Medizinische Informationsverarbeitung, Biometrie und EpidemiologieLudwig-Maximilians-Universität München LMU und Deutsches Schwindel- und Gleichgewichtszentrum (DSGZ) Klinikum der Universität München
    • Ms.  Prof. Dr., MPH  Eva  Grill 
    • Marchinonistr. 17
    • 81377  München
    • Germany
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    • Institut für Medizinische Informationsverarbeitung, Biometrie und EpidemiologieLudwig-Maximilians-Universität München LMU und Deutsches Schwindel- und Gleichgewichtszentrum (DSGZ) Klinikum der Universität München
    • Ms.  Dr.med., PhD  Eva  Kovacs 
    • Marchinonistr. 17
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/02/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.