Trial document




This trial has been registered retrospectively.
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  DRKS00012653

Trial Description

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Title

Increasing influenza and pneumococcal vaccine uptake in the elderly - The Vaccination60+ study

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Trial Acronym

Vaccination60+

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URL of the Trial

http://www.impfen60plus.de

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Brief Summary in Lay Language

Vaccinations are the most important tool for preventing influenza, pneumonia and potentially severe complications like sepsis in the elderly. However, uptake rates for influenza and pneumococcal vaccination are low among the elderly in Germany. Vaccination 60+ is an independent joint research project that aims at increasing vaccination uptake rates among the elderly in the model region Thuringia in Germany.

To achieve this, an intervention is developed that follows principles of evidence-informed health communication and design. Main outcomes of the intervention are increasing vaccine uptake and vaccine incidence along with vaccination- and sepsis related knowledge. Further, we aim at reducing the incidence of influenza and pneumococcal infections and sepsis in the target group as well as the economic burden due to influenza, pneumonia and sepsis for the healthcare system.

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Brief Summary in Scientific Language

Influenza and pneumococcal vaccination can prevent disease and potentially life-threatening complications like sepsis. Elderly people are at increased risk for severe disease and therefore constitute a major target group for vaccination. To increase vaccination coverage, targeted interventions are needed that take theory-based specific determinants of vaccination behaviour into account. Moreover, message and campaign design should consider specific age-related characteristics (e.g. information processing, media use). The aim of Vaccination60+ is (i) to identify the specific informational and interventional needs of this risk-group, (ii) to design a targeted intervention, and (iii) to measure the effect of this evidence-informed intervention on various levels.
Vaccination60+ is a prospective, multi-methods intervention study targeting individuals aged ≥60 years in a model region in Germany (federal state of Thuringia, 500.000 inhabitants ≥60y). The development of the intervention follows theory-based and evidence-informed principles: Data from a cross-sectional representative study provide insights into specific determinants of the target group’s vaccination behavior. Additionally, media use is analyzed to identify adequate communication channels for specific subgroups.
In pilot studies, the intervention materials are adapted to the specific cognitive requirements of the target group. For development and implementation of the intervention, an interdisciplinary and trans-sectoral approach is used, including psychology, communication science, design, medical science, epidemiology, and various public health players. The intervention will be implemented in fall and winter 2017/18 and 2018/19 and adjusted in between. Evaluation of the intervention includes: awareness, use and recall of intervention materials, effects on changes in determinants of vaccination behavior, self-reported vaccine uptake, and vaccination coverage in the intervention area (primary outcomes), as well as disease incidences (secondary outcomes) and the economic burden of influenza, pneumonia, invasive pneumococcal disease, and sepsis for the health care system (tertiary outcomes).
The data will add to the body of evidence on the effectiveness of evidence-informed vaccination campaign development as well as on the clinical and economic effects of pneumococcal and influenza vaccination. The effect of the intervention will teach valuable lessons about the principles of campaign development and evaluation and can motivate a subsequent nationwide intervention.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012653
  •   2017/11/24
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  •   yes
  •   Approved
  •   17/05/29, Ethikbeirat Universität Erfurt
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Secondary IDs

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Health Condition or Problem studied

  •   J10 -  influenza due to identified seasonal influenza virus
  •   J18 -  Pneumonia, organism unspecified
  •   R65.1 -  Systemic Inflammatory Response Syndrome of infectious origin with organ failure
  •   R65.0 -  Systemic Inflammatory Response Syndrome of infectious origin without organ failure
  •   R57.2 -  Septic shock
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Interventions/Observational Groups

  •   Population of the federal state Thuringia, Germany (intervention group): implementation of an evidence-informed campaign to increase vaccination rates of influenza and pneumococcal vaccination and vaccination and sepsis knowledge
  •   Population of other German federal states (control group) without access to the campaign
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Primary outcomes are reasons for non-vaccination and determinants of vaccination behavior as well as uptake rates of influenza and pneumococcal vaccination. These outcomes are measured by a representative telephone survey in Thuringia and other federal countries, as well as the assessment of vaccination rates using routine data by the Kassenärztliche Vereinigung Thüringen during and after the first and second wave of the intervention (autumn and winter 2017/2018 and 2018/2019).

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Secondary Outcome

Secondary outcomes are the reduction of influenza, pneumonia, pneumococcal bacteremia and sepsis incidence in the target group. As a tertiary outcome the reduction of the economic burden of influenza, pneumonia and sepsis for the healthcare system will be assessed. Secondary and tertiary outcomes are assessed after the intervention using different data sources such as the nationwide DRG statistics by the Federal Statistics Office, the Alertsnet Registry for bloodstream infection in Thuringia, claims data of a major social health insurance (AOK PLUS) and data of the Multidisciplinary Quality Assurance in the Health Care System (SQG data).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/09/01
  •   2182000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional Inclusion Criteria

State of residence: Germany

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Exclusion Criteria

age <60 years

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Addresses

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    • Universität Erfurt
    • Ms.  PD Dr. phil.  Cornelia   Betsch 
    • Nordhäuser Straße 63
    • 99089  Erfurt
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Konrad  Reinhart 
    • Am Klinikum 1
    • 07743  Jena
    • Germany
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    • Zentrum für Infektionsmedizin und Krankenhaushygiene, Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Matthias  Pletz 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Robert-Koch-Institut
    • Mr.  Dr. med.  Ole  Wichmann 
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    • Seminar für Medien- und Kommunikationswissenschaft, Universität Erfurt
    • Ms.  Prof. Dr. phil.  Constanze  Rossmann 
    • Nordhäuser Str. 63
    • 99089  Erfurt
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    • Lindgrün GmbH
    • Mr.  Wolfgang  Hanke 
    • Cuxhavener Str. 12
    • 10555  Berlin
    • Germany
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    •   030 39903400
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    • Institut für Allgemeinmedizin, Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Horst Christian  Vollmar, MPH 
    • Bachstraße 18
    • 07743  Jena
    • Germany
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    • Universität Erfurt
    • Ms.  PD Dr. phil.  Cornelia  Betsch ‎ 
    • Nordhäuser Straße 63
    • 99089  Erfurt
    • Germany
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    • Universität Erfurt
    • Ms.  Nora Katharina  Küpke 
    • Nordhäuser Straße 63
    • 99089  Erfurt
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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