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

NCT05193903 | Unknown

• 1 other identifier: VSF1_2021-194
• Study Type: interventional
• Target: 1,188
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Infection

Keywords

COVID-19 vaccination, vaccine-hesitancy

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after Intervention (T1)

Secondary Outcomes (3)

• Change from baseline assessment of vaccine-related benefiit-to-harm at T1

  Immediately after Intervention (T1)

• Number of GP counselings at 6-months follow-up

  6-months follow up (T2)

• Actual vaccination behavior at T2

  6-months follow up (T2)

Study Arms (2)

Intervention: Simulation

EXPERIMENTAL

Interactive information tools

Behavioral: Simulation

Control: Text

OTHER

Standard text-based information

Behavioral: Text

Interventions

Simulation BEHAVIORAL

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.

Intervention: Simulation

Text BEHAVIORAL

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.

Control: Text

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Ludwig-Maximilians - University of Munich: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Medical Center Mainz: collaborator
• Max Planck Institute for Human Development: collaborator
• Federal Joint Committee: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

MeSH Terms

Conditions

COVID-19; Vaccination Hesitancy

Interventions

Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Self-Help Devices; Equipment and Supplies

Study Officials

• Odette Wegwarth, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Odette Wegwarth, Prof. Dr.

CONTACT

+49(0) 30 450 531 074; odette.wegwarth@charite.de

Clara O Schirren, MA

CONTACT

+49(0) 30 450 - 531 056; clara.schirren@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 1 intervention group, 1 control group (Cross-sectional study)

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 18, 2022
• Study Start: February 3, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 28, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

DE (1)