Trial document
This trial has been registered retrospectively.
DRKS00012653
Trial Description
Title
Increasing influenza and pneumococcal vaccine uptake in the elderly - The Vaccination60+ study
Trial Acronym
Vaccination60+
URL of the Trial
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.
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.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00012653
- 2017/11/24
- [---]*
- yes
- Approved
- 17/05/29, Ethikbeirat Universität Erfurt
Secondary IDs
- [---]*
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
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
Characteristics
- Interventional
- [---]*
- Non-randomized controlled trial
- Open (masking not used)
- [---]*
- Control group receives no treatment
- Prevention
- Other
- N/A
- N/A
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).
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).
Countries of Recruitment
- Germany
Locations of Recruitment
- other
Recruitment
- Actual
- 2017/09/01
- 2182000
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 60 Years
- no maximum age
Additional Inclusion Criteria
State of residence: Germany
Exclusion Criteria
age <60 years
Addresses
-
start of 1:1-Block address primary-sponsor
- Universität Erfurt
- Ms. PD Dr. phil. Cornelia Betsch
- Nordhäuser Straße 63
- 99089 Erfurt
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena
- Mr. Prof. Dr. med. Konrad Reinhart
- Am Klinikum 1
- 07743 Jena
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 036419323192
- [---]*
- Konrad.Reinhart at med.uni-jena.de
- http://www.uniklinikum-jena.de
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Zentrum für Infektionsmedizin und Krankenhaushygiene, Universitätsklinikum Jena
- Mr. Prof. Dr. med. Matthias Pletz
- Am Klinikum 1
- 07747 Jena
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 03641 9-324794
- [---]*
- mathias.pletz at med.uni-jena.de
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Robert-Koch-Institut
- Mr. Dr. med. Ole Wichmann
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- WichmannO at rki.de
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Seminar für Medien- und Kommunikationswissenschaft, Universität Erfurt
- Ms. Prof. Dr. phil. Constanze Rossmann
- Nordhäuser Str. 63
- 99089 Erfurt
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- constanze.rossmann at uni-erfurt.de
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Lindgrün GmbH
- Mr. Wolfgang Hanke
- Cuxhavener Str. 12
- 10555 Berlin
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 030 39903400
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Institut für Allgemeinmedizin, Universitätsklinikum Jena
- Mr. Prof. Dr. med. Horst Christian Vollmar, MPH
- Bachstraße 18
- 07743 Jena
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 03641 9-39 58 00
- [---]*
- horst.vollmar at med.uni-jena.de
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Universität Erfurt
- Ms. PD Dr. phil. Cornelia Betsch
- Nordhäuser Straße 63
- 99089 Erfurt
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0361 737-1631
- [---]*
- cornelia.betsch at uni-erfurt.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universität Erfurt
- Ms. Nora Katharina Küpke
- Nordhäuser Straße 63
- 99089 Erfurt
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 361 737-1638
- [---]*
- nora_katharina.kuepke at uni-erfurt.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bundesministerium für Bildung und Forschung Dienstsitz Berlin
- Friedrichstraße 130 B
- 10117 Berlin
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 030 20199482
- [---]*
- k.boehme at fz-juelich.de
- http://www.bmbf.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*