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Exploring the Effect of Video Interventions on Intentions for Continued COVID-19 Vaccination

Primary Purpose

Vaccine Refusal, COVID-19

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Informational Video
Altruistic Video
Individualistic Video
Sponsored by
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccine Refusal focused on measuring Vaccine Hesitancy, Vaccine Decision Making

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Residing within Canada Aged between 18 and 39. Exclusion Criteria: -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Informational Video

    Informational + Altruistic Video

    Informational + Altruistic + Individualistic Video

    Arm Description

    Participants will watch a 1-minute video detailing the impact vaccination has had on the COVID-19 pandemic, where accurate information on vaccination can be found, and the convenience of vaccination.

    Participants will first watch the 1-minute informational video before watching an additional 40-second video eliciting altruistic motivations for vaccination. The purpose of this arm is to test whether altruistic messages are efficacious to increase vaccine intentions beyond providing only vaccine information.

    Participants will watch the 1-minute informational video, the 40-second altruistic video, and an additional 40-second video eliciting individualistic motivations for vaccination. This arm will be used to test if combined altruistic and individualistic messages provide a greater effect than providing only vaccine information.

    Outcomes

    Primary Outcome Measures

    Vaccine Intentions
    Intentions to receive COVID-19 vaccines as they are continually recommended will be measured using the Precaution Adoption Process Model (PAPM). The PAPM is a stage-based model of health decision-making, and will be adapted to contain the categories: unengaged, undecided, decided to, and decided not to receive recommended COVID-19 vaccines. Participants will provide their stage before and after the intervention has been administered, all within the same survey.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2023
    Last Updated
    April 12, 2023
    Sponsor
    Sir Mortimer B. Davis - Jewish General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05808413
    Brief Title
    Exploring the Effect of Video Interventions on Intentions for Continued COVID-19 Vaccination
    Official Title
    Promoting Protection of Others to Increase Future COVID-19 Booster Shot Vaccination Intentions in Younger Adult Canadians: Evaluating the Efficacy of Short Video-based Interventions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sir Mortimer B. Davis - Jewish General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    While COVID-19 vaccine uptake has generally been high in Canada, with 83.4% of the total population having received the first two doses (i.e., primary series), additional "booster" uptake has been slower, especially among young adults aged 18-39. Throughout the pandemic, young adults have experienced less personal risk from COVID-19 infection and this has led to lower motivation to vaccinate when it is recommended. Achieving high rates of up-to-date vaccine coverage is important in this group to anticipate new variants and waves of infection and changes to recommendations which might include annual or seasonal vaccination. Three video interventions, intended to motivate Canadian young adults to adopt positive intentions toward continued COVID-19 vaccination, will be developed and tested: an informational comparison video, an altruistic video, and an individualistic video. Participants will be 3300 Canadian younger adults who will be randomly assigned to watch these videos. The first arm will only receive the informational video, the second arm the informational and altruistic videos, and the third arm the informational, altruistic, and individualistic videos. All participants will complete a brief online survey before and after viewing the assigned video(s). The goal of the study is to examine the efficacy of altruistic and individualistic messages, beyond informational messages, in increasing intentions for COVID-19 vaccination in this age group.
    Detailed Description
    The COVID-19 vaccine has significantly reduced mortality from the COVID-19 disease, and relieved the pressure on society, the economy, and the healthcare system caused by the pandemic. However, waning immunity and the emergence of new, vaccine-evasive variants like Omicron have necessitated additional vaccine doses, or "booster shots". Similar to trends for COVID-19 vaccination and other routine vaccinations, young adults (aged 18-39) have demonstrated lower uptake of booster vaccination, and evidence suggests that public health recommendations are no longer translating to vaccine uptake. This study will examine the efficacy of altruistic and individualistic messages over informational messages in increasing vaccine intentions in this age group. This study has four primary objectives: Estimate pre- to post-intervention changes in COVID-19 vaccine intentions of a altruistic video intervention. Estimate pre- to post-intervention changes in COVID-19 vaccine intentions of a combined altruistic + individualistic video Estimate between-group (altruistic vs. vaccine-informational) differences in COVID-19 vaccine intentions post-intervention Estimate the between-group (altruistic + individualism vs. vaccine-informational) differences in COVID-19 vaccine intentions post-intervention In addition, there is an exploratory, multivariable objective: 1. To estimate the multivariable associations of vaccine intentions in each intervention group. A survey will be administered online to a sample of Canadian residents, aged 18-39, in both English and French. Participants will be drawn from a database panel provided by Dynata, a multinational first-party data and insight platform. Dynata's use of Canadian census data from Statistics Canada and quota-based sampling will ensure that the sample will closely match the Canadian population in terms of age (18-29, 30-39), sex, first language English/French, population density (i.e., urban vs. rural), and household income. Dynata will send invitations in various forms (e.g., e-mail invitations, text messages and in-app alerts) to recruit eligible participants from their existing panel (individuals who have signed with Dynata and have expressed willingness to receive invitations to various appropriate surveys) until recruitment goals and quotas are met. To calculate the required sample size for the within-participant change in vaccine hesitancy (i.e., pre-post intervention) hesitancy towards continuing to receive booster vaccination was estimated at about 70% in the sample population. This estimate of the hesitancy rate at time of writing was based on seasonal influenza vaccination uptake in the target age range (between 20-25%) and uptake of COVID-19 booster vaccination in the past 6 months (9.2 - 14.5%) accounting for a gradual increase in uptake observed over time. Informed by results of a previous two-arm RCT conducted by this research team (NCT04960228) that included a video-based intervention and an active control group, it is estimated that the intentions in the control group will increase from 30% to 33% and in the intervention groups from 30% to 39%. To detect a 6% difference in intentions between arms, at a 95% confidence level (for a two-sided significance level α=0.025) and a desired statistical power of 80%, it was calculated that the minimum required number of participants per arm would be N=1005. 1:1:1 randomization will be used the three between groups. Thus, one-third of the participants will be allocated to each intervention group. Including 95 additional participants per arm to account for possible inattentive responders, the total sample required for this study is 3300 participants i.e., 1100 in each of the two experimental groups and 1100 in the active comparator group. Stratified randomization will be used for first language (English/French), sex (male/female), population density (Urban/rural) and household income (<$75,000 / >$75,000) to allocate participants to either intervention arm. Within each stratum, a random concept picker approach will be used to ensure a 1:1:1 allocation using groups of three participants. Correspondingly, the first participant of a group will be randomly allocated to one of the three study arms, the second randomly assigned to one of the two remaining arms, and the third to the remaining arm. If a participant does not finish the survey (incomplete data), that place in the group will be allocated to the next participant. Thus, the quota in each stratum will be filled in groups of three and ensure a balanced group allocation throughout data collection. The initial online survey will be approximately 12 minutes in length and will be available in both French and English. After reading the introductory statement of the study, participants will be asked for their consent to take part in the survey. Those who consent to participate will be invited to go to the next page and start completing the survey. Participants will first be asked to answer several socio-demographic questions and will be asked to choose their current Precaution Adoption Process Model stage for continued COVID-19 vaccination. Participants will then watch the assigned intervention. After viewing this content, to ensure that participants paid attention, participants will answer questions about the interventions to check their attention. Finally, participants will: 1) once again be asked to choose their vaccine decision-making stage; 2) be asked questions regarding previous vaccination history (e.g., seasonal influenza, COVID-19), lifestyle factors, self-perceived health status, personal history of SARS-CoV-2 infection, and preferred health-information channels; and 3) complete validated scales regarding, empathy, distress, intolerance of uncertainty, individualism and collectivism, COVID-19 pandemic fatigue, intellectual humility, and social desirability. To test within-participant outcomes (Objectives 1 and 2), McNemar's test will be used to compare paired (pre and post-intervention) proportions. Additionally, exact tests of symmetry comprising of multiple pairwise McNemar tests to estimate pre-post changes in vaccine intentions. Adjusted p values for multiple comparisons, odds ratios (OR) and Cohen's g effect sizes will be reported. For each study group, the significant transitions between vaccine intention stage pairs will be used for calculating the total number of participants that changed towards increased vaccination intentions (e.g., from undecided to decided to). To test between-group outcomes (Objectives 3 and 4), the Chi-square test will be used to examine differences in PAPM stage proportions between intervention groups. For the exploratory objective, Structural Equation Modelling will be used to identify multivariable associations of vaccine intentions (e.g., collectivism, empathy, intolerance of uncertainty) and to control for the potential effect of other factors (e.g., sociodemographics, psychosocial factors, previous influenza vaccination, lifestyle factors).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaccine Refusal, COVID-19
    Keywords
    Vaccine Hesitancy, Vaccine Decision Making

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly assigned to one of: 1) a control video, 2) the control + an altruistic video, or 3) the control + altruistic video + individualistic video. A 1:1:1 randomization ratio will be used.
    Masking
    Investigator
    Masking Description
    The survey company, Dynata, will collect all data and manage group assignments. Participants' intervention group assignments will be unavailable to the investigator.
    Allocation
    Randomized
    Enrollment
    3300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Informational Video
    Arm Type
    Active Comparator
    Arm Description
    Participants will watch a 1-minute video detailing the impact vaccination has had on the COVID-19 pandemic, where accurate information on vaccination can be found, and the convenience of vaccination.
    Arm Title
    Informational + Altruistic Video
    Arm Type
    Experimental
    Arm Description
    Participants will first watch the 1-minute informational video before watching an additional 40-second video eliciting altruistic motivations for vaccination. The purpose of this arm is to test whether altruistic messages are efficacious to increase vaccine intentions beyond providing only vaccine information.
    Arm Title
    Informational + Altruistic + Individualistic Video
    Arm Type
    Experimental
    Arm Description
    Participants will watch the 1-minute informational video, the 40-second altruistic video, and an additional 40-second video eliciting individualistic motivations for vaccination. This arm will be used to test if combined altruistic and individualistic messages provide a greater effect than providing only vaccine information.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Informational Video
    Intervention Description
    This video emphasizes that vaccination against COVID-19 continues to be important, highlights the importance of seeking accurate information, and provides statistics about the estimated number of lives saved by vaccination and reported adverse events following vaccination in Canada.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Altruistic Video
    Intervention Description
    This video presents a vignette about a young adult woman who has many social interactions during her daily life. It shows that her decision to stay up-to-date on COVID-19 vaccination could help to protect those people she comes into contact with, who may be at greater risk from COVID-19 infection. Statistics are used to show that up to one-in-four people in Canada have underlying conditions that make them more vulnerable to COVID-19, and to quantify the number of surgeries that were delayed by pandemic-related disruptions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individualistic Video
    Intervention Description
    This video presents a vignette about a young adult man who is very health-conscious. He is unsure about staying up-to-date on COVID-19 vaccination until he learns that COVID-19 infection can have serious and disruptive consequences even if someone is younger. Statistics are used to quantify the increased risk of severe symptoms in young adults who are not up-to-date on vaccination.
    Primary Outcome Measure Information:
    Title
    Vaccine Intentions
    Description
    Intentions to receive COVID-19 vaccines as they are continually recommended will be measured using the Precaution Adoption Process Model (PAPM). The PAPM is a stage-based model of health decision-making, and will be adapted to contain the categories: unengaged, undecided, decided to, and decided not to receive recommended COVID-19 vaccines. Participants will provide their stage before and after the intervention has been administered, all within the same survey.
    Time Frame
    Pre- and post-intervention, within the same survey. The length of the survey is projected to be about 12 minutes.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Residing within Canada Aged between 18 and 39. Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zeev Rosberger, PhD
    Phone
    5142408222
    Ext
    24215
    Email
    zeev.rosberger@mcgill.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ben Haward, BA
    Email
    benjamin.haward@mail.mcgill.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zeev Rosberger, PhD
    Organizational Affiliation
    Lady Davis Institute for Medical Research of the Jewish General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The consent form, data collection method, and organizational policy means only aggregated data will be shared with other researchers.
    Citations:
    PubMed Identifier
    35544437
    Citation
    Zhu P, Tatar O, Griffin-Mathieu G, Perez S, Haward B, Zimet G, Tunis M, Dube E, Rosberger Z. The Efficacy of a Brief, Altruism-Eliciting Video Intervention in Enhancing COVID-19 Vaccination Intentions Among a Population-Based Sample of Younger Adults: Randomized Controlled Trial. JMIR Public Health Surveill. 2022 May 30;8(5):e37328. doi: 10.2196/37328.
    Results Reference
    background
    PubMed Identifier
    36992212
    Citation
    Zhu P, Tatar O, Haward B, Steck V, Griffin-Mathieu G, Perez S, Dube E, Zimet G, Rosberger Z. Examining an Altruism-Eliciting Video Intervention to Increase COVID-19 Vaccine Intentions in Younger Adults: A Qualitative Assessment Using the Realistic Evaluation Framework. Vaccines (Basel). 2023 Mar 11;11(3):628. doi: 10.3390/vaccines11030628.
    Results Reference
    background
    PubMed Identifier
    29611455
    Citation
    Brewer NT, Chapman GB, Rothman AJ, Leask J, Kempe A. Increasing Vaccination: Putting Psychological Science Into Action. Psychol Sci Public Interest. 2017 Dec;18(3):149-207. doi: 10.1177/1529100618760521.
    Results Reference
    background
    PubMed Identifier
    34479746
    Citation
    Yuan S, Chu H. Vaccine for yourself, your community, or your country? Examining audiences' response to distance framing of COVID-19 vaccine messages. Patient Educ Couns. 2022 Feb;105(2):284-289. doi: 10.1016/j.pec.2021.08.019. Epub 2021 Aug 25.
    Results Reference
    background
    PubMed Identifier
    36104675
    Citation
    Reifferscheid L, Lee JSW, MacDonald NE, Sadarangani M, Assi A, Lemaire-Paquette S, MacDonald SE. Transition to endemic: acceptance of additional COVID-19 vaccine doses among Canadian adults in a national cross-sectional survey. BMC Public Health. 2022 Sep 14;22(1):1745. doi: 10.1186/s12889-022-14025-8.
    Results Reference
    background

    Learn more about this trial

    Exploring the Effect of Video Interventions on Intentions for Continued COVID-19 Vaccination

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