COVID-19 InfectioniWILLNCT05193903
Evaluation of an Interactive Risk Information Tool to Increase COVID-19 Vaccination Incidence in Vaccine-hesitant People
A study testing Simulation and Text in people with COVID-19 Infection, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Simulation and Text
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,188 participants
- Where
- 1 siteGermany
- Study dates
- 3 Feb 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hesitancy towards COVID-19 vaccination
- Not yet vaccinated against COVID-19
- Age ≥ 18 years.
Who cannot join
- No hesitancy towards COVID-19 vaccination
- Already vaccinated
- Age < 18 years.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin
Odette Wegwarth, Prof. Dr., +49(0) 30 450 - 531 074, odette.wegwarth@charite.de
Odette Wegwarth, Prof. Dr.
About this study
Official title: Evaluation of an Interactive Risk Information Tool to Increase COVID-19 Vaccination Incidence in Vaccine-hesitant People During Omicron Wave in Germany
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.
Read the 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:
- 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,
- 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,
- to test whether the intervention is superior as compared to the control on these endpoints,
- 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).
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.
- Conditions
- COVID-19 Infection
- Being tested
- Simulation, Text
- Keywords
- COVID-19 vaccination, vaccine-hesitancy
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationBehavioural
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.
TextBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Simulation | Experimental | Interactive information tools Receives: Behavioral: Simulation |
| Control: Text | Other | Standard text-based information Receives: Behavioral: Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after Intervention (T1)
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: 6-months follow up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start3 Feb 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 intervention group, 1 control group (Cross-sectional study)
- Masking
- None (open label)
- Enrolment
- 1,188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Universitätsklinikum Hamburg-Eppendorf, University Medical Center Mainz, Max Planck Institute for Human Development, Federal Joint Committee
- Responsible party
- Principal investigator, Odette Wegwarth, Charite University, Berlin, Germany
- Investigators
- Odette Wegwarth, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193903
- Sponsor's protocol ID
- VSF1_2021-194
- Acronym
- iWILL
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2021
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Interactive Risk Information Tool to Increase COVID-19 Vaccination Incidence in Vaccine-hesitant People During Omicron Wave in Germany
- ClinicalTrials.gov ID
- NCT05193903
- Acronym / sponsor ID
- iWILL / VSF1_2021-194
- Conditions
- COVID-19 Infection
- Keywords
- COVID-19 vaccination, vaccine-hesitancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,188 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Universitätsklinikum Hamburg-Eppendorf, University Medical Center Mainz, Max Planck Institute for Human Development, Federal Joint Committee
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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,
- 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,
- to test whether the intervention is superior as compared to the control on these endpoints,
- 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).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 intervention group, 1 control group (Cross-sectional study)
| Arm | Type | Receives |
|---|---|---|
| Intervention: Simulation | Experimental | Behavioral: SimulationInteractive information tools |
| Control: Text | Other | Behavioral: TextStandard text-based information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hesitancy towards COVID-19 vaccination
- Not yet vaccinated against COVID-19
- Age ≥ 18 years.
Key exclusion criteria (3 listed)
- No hesitancy towards COVID-19 vaccination
- Already vaccinated
- Age < 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimulationThe 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. | Behavioural | Intervention: Simulation |
| TextThe 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. | Behavioural | Control: Text |
Primary outcome
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.
3 secondary outcomes
Change from baseline assessment of vaccine-related benefiit-to-harm at T1
Time frame: Immediately after Intervention (T1)
Number of GP counselings at 6-months follow-up
Time frame: 6-months follow up (T2)
Actual vaccination behavior at T2
Time frame: 6-months follow up (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odette Wegwarth, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation and Text in people with COVID-19 Infection, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odette Wegwarth, Prof. Dr. (+49(0) 30 450 531 074, odette.wegwarth@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline vaccination intention at T1 (time frame: Immediately after Intervention (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.