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临床试验/NCT05193903
NCT05193903招募中不适用

Evaluation of an Interactive Risk Information Tool to Increase COVID-19 Vaccination Incidence in Vaccine-hesitant People During Omicron Wave in Germany

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 1,188 人开始时间: 2022年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,188
试验地点
1
主要终点
Change from baseline vaccination intention at T1

研究概览

简要总结

Coronavirus (COVID-19) vaccines have saved millions of lives since release and remain a key tool in the fight against the pandemic.

However, most countries have not reached the vaccine uptake rates needed to relieve pressure on hospitals and intensive care units (ICUs) during peak corona periods. Reduced effectiveness of vaccines in preventing infections with the Omicron variant and milder courses of the disease may trigger and support beliefs that vaccination is no longer necessary, especially among vaccine sceptics.The term 'vaccine sceptic', however, is used heterogeneously and often interchangeably to describe both 'vaccine hesitants' and 'vaccine deniers'. In contrast to vaccine deniers, characterized by a definite and unwavering decision not to get vaccinated, vaccine hesitants are characterized by a spectrum of indecisiveness, with a high need for information on both benefits and harms. They may still decide to get vaccinated if information succeeds in convincing them. In light of the potential for a change of mind in vaccine-hesitants the key question is: How does one best address their high needs for balanced risk ratio information? Evidence from cognitive and behavioral science suggests that interactive simulations of risk information, which imitate mechanisms by which humans sequentially and experientially sample risk information naturally, can be more effective in helping people develop adequate risk perceptions and initiate behavioral change than the ubiquitously used conventional text-based formats. The study therefore seeks to determine if interactive risk ratio simulation relative to a text-based format are more effective in prompting positive change in unvaccinated, vaccine-hesitant respondents' intention to get the COVID-19 and also in the respective benefit-to-harm ratio assessment during the Omicron wave in Germany.

详细描述

The iWILL study is a cross sectional study that aims to evaluate the effectiveness of interactive risk ratio simulation (intervention) relative to a text-based format (control) in COVID-19 vaccine-hesitant people in Germany.

The objectives of iWILL are:

  1. to adapt the already piloted, digital, interactive, evidence-based counseling tool ExploreVac (focus on herd protection) as well as a new simulation (focus on individual protection) to the most current evidence (including age adjustment) for communicating vaccine effectiveness and side effects as evidence-based patient information using the example of COVID-19 vaccination,
  2. to implement the adapted version of ExploreVac and the new simulation in care with the aim to increase the vaccination incidence among vaccine hesitant individuals, to improve their subjective assessment of vaccination's benefits and harms, and to reduce the presumed increased counseling effort of the GP compared to standard care,
  3. to test whether the intervention is superior as compared to the control on these endpoints,
  4. to draw conclusions about the transferability of the developed method for other established vaccinations (HPV, influenza protection) and vaccinations for future infectious diseases.

Primary hypothesis:

(H1) The intervention group (interactive simulations) will show a higher positive change (T0/baseline to T1/after intervention) in vaccination intention than the control group (text-based information).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Hesitancy towards COVID-19 vaccination
  • •Not yet vaccinated against COVID-19
  • •Age ≥ 18 years.

排除标准

  • •No hesitancy towards COVID-19 vaccination
  • •Already vaccinated
  • •Age < 18 years.

研究组 & 干预措施

Control: Text

Other

Standard text-based information

干预措施: Text (Behavioral)

Intervention: Simulation

Experimental

Interactive information tools

干预措施: Simulation (Behavioral)

结局指标

主要结局

Change from baseline vaccination intention at T1

时间窗: Immediately after Intervention (T1)

Change in 5-point response scale of vaccination intention between baseline and post-intervention judgement "I will definitely get the COVID-19 vaccination"; "I will probably get the COVID-19 vaccination"; "I am unsure if I will get the COVID-19 vaccination"; "I will probably not get the COVID-19 vaccination", and "I will definitely not get the COVID-19 vaccination." NOTE: This scale is categorical, that means values are only used to distinguish between the 5 categories and DO NOT indicate better or worse outcomes.

次要结局

  • Number of GP counselings at 6-months follow-up(6-months follow up (T2))
  • Change from baseline assessment of vaccine-related benefiit-to-harm at T1(Immediately after Intervention (T1))
  • Actual vaccination behavior at T2(6-months follow up (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Odette Wegwarth

Prof. Dr.

Charite University, Berlin, Germany

研究点 (1)

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