An interventional study of Simulation and Text in COVID-19 Infection, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science
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.
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:
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).
Secondary hypotheses:
(H2) The intervention group (interactive simulations) will show a higher positive change (T0/baseline to T1/after intervention) in their positive subjective benefit-to-harm assessment of the COVID-19 vaccine's benefit-to-harm ratio than does the control group.
(H3) The intervention group reports a lower need for additional counseling by their GPs than does the control group.
(H4) The intervention group (interactive simulations) will show a higher correspondence between their intended behavior (T1) and their actual reported vacccinataion behavior (T2/ follow-up after 6 months).
Recruitment of unvaccinated, vaccine hesitant German residents will be established by using probability-based internet panels maintained by respondi (Cologne, Germany). The study will be pursued with cross-sectional national sample.
Intervention condition: two interactive simulations informing 1) about absolute risks of infection, hospitalization, ICU admission, and death after exposure to COVID-19 relative to vaccination's side effects (e.g., myocarditis in men ≤35 years) in 100,000 vaccinated and 100,000 unvaccinated individuals, all adjustable to four different age groups (18- 34 years, 35-59 years, 60-79 years, ≥ 80 years due to considerable differences in each of the depicted risks (Supplement) and 2) about the benefits of vaccination for the population as a whole (herd) in terms of preventing infections and deaths.
Control condition (see also below): two text module informing 1) about absolute risks of infection, hospitalization, ICU admission, and death after exposure to COVID-19 relative to vaccination's side effects (e.g., myocarditis in men ≤35 years) in 100,000 vaccinated and 100,000 unvaccinated individuals, all adjustable to four different age groups (18- 34 years, 35-59 years, 60-79 years, ≥ 80 years due to considerable differences in each of the depicted risks (Supplement) and 2) about the benefits of vaccination for the population as a whole (herd) in terms of preventing infections and deaths.
The educative information material in both conditions is based on non-directive evidence-based patient counseling according to the guideline on evidence-based health information. After the study condition, participants are informed that any further questions about vaccination can be discussed with the GP.
The questionnaire at T0 (baseline) and T1 (directly after the intervention) takes maximum 10 minutes to complete (without exploration of intervention material). Given that participants are free to spend as much time as participants want with the educative information material, the total survey time can be longer, however.
About six months after first participation in the study, participants are re-contacted via e-mail and are asked to fill out a second questionnaire (6-months follow-up, T2), which approximately takes about 5 minutes to complete to learn more about potential the translation of the intention into vaccination behavior.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's planned enrollment of 1,188 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
Interactive information tools
Behavioral: Simulation
Standard text-based information
Behavioral: Text
The participants in the intervention group receive two interactive simulations in addition to a general text module that provides sequential, animated information on the spread of the virus without prevention, the effectiveness of vaccination and potential side effects of vaccination on a herd protection level and the individual level.
The participants in the control group receive two text-based information in addition to a general text module that provides information on the spread of the virus without prevention, the effectiveness of vaccination and potential side effects of vaccination on a herd protection level and the individual level. Both conditions ensure the provision of a level of knowledge that at least corresponds to standard care.
Change from baseline vaccination intention at 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.
Time frame: Immediately after Intervention (T1)
Change from baseline assessment of vaccine-related benefiit-to-harm at T1
Change in 5-point response scale of vaccine-related benefiit-to-harm assessment The benefits of the COVID-19 vaccination clearly outweigh the harms," "The benefits of the COVID-19 vaccination somewhat outweigh the harms," "Benefits and harms of the COVID-19 vaccination are balanced," "The harms of the COVID-19 vaccination somewhat outweigh the benefits," "The harms of the COVID-19 vaccination clearly outweigh the benefits." 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.
Time frame: Immediately after Intervention (T1)
Number of GP counselings at 6-months follow-up
Measured by the number of visits of the GP to receive additional counselling on the vaccine after study intervention/control
Time frame: 6-months follow up (T2)
Actual vaccination behavior at T2
Used to check for correspondence between vaccination intention expressed at T1 and actual behvavior at T2
Time frame: 6-months follow up (T2)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Jan 2023, 11 months after the start.
Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's planned 11 months is close to that.
Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →