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Clinical Trials/NCT05193903
NCT05193903RecruitingNot Applicable

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 site in 1 country1,188 target enrollmentStarted: February 3, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,188
Locations
1
Primary Endpoint
Change from baseline vaccination intention at T1

Study Overview

Brief Summary

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.

Detailed Description

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Control: Text

Other

Standard text-based information

Intervention: Text (Behavioral)

Intervention: Simulation

Experimental

Interactive information tools

Intervention: Simulation (Behavioral)

Outcomes

Primary Outcomes

Change from baseline vaccination intention at T1

Time Frame: 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.

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Odette Wegwarth

Prof. Dr.

Charite University, Berlin, Germany

Study Sites (1)

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