Dartmouth College
Lebanon, New Hampshire, 03756, United States
NCT Number: NCT05168800
The CONFIDENT Study is an online three-arm randomized trial that aims to help long-term care workers in the United States feel more confident about the Coronavirus Disease 2019 (COVID-19) vaccines. The study will compare two different interventions to usual online information (website of the Centers for Disease Control and Prevention). The first intervention is a Dialogue-Based Webinar where people can interact and ask questions about the vaccines. The second intervention is a Social Media Website that will feature curated content about the vaccines from popular social media platforms.
Participants will be asked to completed four online surveys. The first survey will be completed pre-intervention and immediately upon study enrollment (Time 0). Participants will be randomized to a trial arm at the end of the Time 0 survey. Intervention follow-up surveys will be completed 3 weeks post-randomization (Time 1), three months post-randomization (Time 2), and 6 months post-randomization (Time 3).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Lebanon, New Hampshire, 03756, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One-time virtual webinars facilitated by a long-term care worker and a physician expert. The webinars will include provision of the existing COVID-19 vaccine Option Grid(TM) conversation aid. The majority of time will be focused on answering participants' questions about COVID-19 and the COVID-19 vaccines. An additional refresher intervention will be delivered several weeks later that will comprise of an email with links to a pre-recorded, shorter webinar available in video and audio-only formats.
Other names: Discussion Session
A curated COVID-19 social media website. The website will feature content from different social media platforms. The posts will include information about COVID-19 and the COVID-19 vaccines. Participants will have the ability to like and comment on website content and can re-visit the website as many times as they like. An additional refresher intervention will be delivered several weeks later that will comprise of an email featuring previews and links to a selection of website content.
Other names: Social Site
COVID-19 vaccine information on the Centers for Disease Control and Prevention (CDC) website. An additional refresher will be delivered several weeks later that will comprise of an email with a link to the COVID-19 vaccine information on the CDC website.
Other names: Online Information
Time frame: 3 weeks post-randomization (Time 1)
Confidence in the COVID-19 vaccines, assessed using the 3-item Vaccine Confidence Index (Larson et al., 2016) adapted for COVID-19. Each item is rated on a 5-point scale ranging from 1 ('Strongly disagree') to 5 ('Strongly agree'). Respondents are considered 'confident' (score of '1') if they respond 'Agree' or 'Strongly agree' on all three items and 'not confident' (score of '0') if one or more item responses is not 'Agree' or 'Strongly agree'.
Time frame: Baseline (Time 0); 3 weeks post-randomization (Time 1)
Change in confidence in the COVID-19 vaccines from baseline to 3 weeks post-randomization, assessed using the 3-item Vaccine Confidence Index (Larson et al., 2016) adapted for COVID-19. Each item is rated on a 5-point scale ranging from 1 ('Strongly disagree') to 5 ('Strongly agree'). Respondents are considered 'confident' (score of '1') if they respond 'Agree' or 'Strongly agree' on all three items and 'not confident' (score of '0') if one or more item responses is not 'Agree' or 'Strongly agree'. For the change from baseline to Time 1 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence.
Time frame: Baseline (Time 0); 3 months post-randomization (Time 2)
Change in confidence in the COVID-19 vaccines from baseline to 3 months post-randomization, assessed using the 3-item Vaccine Confidence Index (Larson et al., 2016) adapted for COVID-19. Each item is rated on a 5-point scale ranging from 1 ('Strongly disagree') to 5 ('Strongly agree'). Respondents are considered 'confident' (score of '1') if they respond 'Agree' or 'Strongly agree' on all three items and 'not confident' (score of '0') if one or more item responses is not 'Agree' or 'Strongly agree'. For the change from baseline to Time 2 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence.
Time frame: Baseline (Time 0); 6 months post-randomization (Time 3)
Change in confidence in the COVID-19 vaccines from baseline to 6 months post-randomization, assessed using the 3-item Vaccine Confidence Index (Larson et al., 2016) adapted for COVID-19. Each item is rated on a 5-point scale ranging from 1 ('Strongly disagree') to 5 ('Strongly agree'). Respondents are considered 'confident' (score of '1') if they respond 'Agree' or 'Strongly agree' on all three items and 'not confident' (score of '0') if one or more item responses is not 'Agree' or 'Strongly agree'. For the change from baseline to Time 3 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence.
Time frame: 3 weeks post-randomization (Time 1)
Likelihood of recommending COVID-19 vaccination to someone who is not vaccinated, assessed using a single-item adapted Net Promoter Score item. The item is assessed on an 11-point scale ranging from 0 ('No at all likely') to 10 ('Extremely likely'). Responses are categorized into three groups: Promoters (scale score of 9 or 10) receive a score of '1', passives (scale score of 7 or 8) receive a score of '0', and detractors (scale score of 0-6) receive a score of '-1'.
Time frame: 3 weeks post-randomization (Time 1)
Likelihood of recommending COVID-19 booster vaccination to a coworker, assessed using a single-item adapted Net Promoter Score item. The item is assessed on an 11-point scale ranging from 0 ('No at all likely') to 10 ('Extremely likely'). Responses are categorized into three groups: Promoters (scale score of 9 or 10) receive a score of '1', passives (scale score of 7 or 8) receive a score of '0', and detractors (scale score of 0-6) receive a score of '-1'.
Time frame: 3 weeks post-randomization (Time 1)
Receipt of any does of a COVID-19 vaccine, assessed using a single item with multiple choice (single answer) format.
Time frame: 3 weeks post-randomization (Time 1)
Completion of initial COVID-19 vaccine series, assessed using two items with multiple choice (single answer) formats.
Time frame: 3 weeks post-randomization (Time 1)
Receipt of a COVID-19 booster vaccine if initial series completed, assessed using a single item with multiple choice (single answer) format.
Time frame: 3 weeks post-randomization (Time 1)
Intent to get a COVID-19 vaccine if unvaccinated, assessed using a single item with multiple choice (single answer) format. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1').
Time frame: 3 weeks post-randomization (Time 1)
Intent to get a COVID-19 booster vaccine if not yet received, assessed using a single item with multiple choice (single answer) format. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1').
Time frame: 3 weeks post-randomization (Time 1)
Intent to get COVID-19 vaccines regularly in the future if they are recommended, assessed using a single item with multiple choice (single answer) format. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1').
Time frame: 3 weeks post-randomization (Time 1)
Extent of feeling informed (having enough information and understanding that information) about the COVID-19 vaccines, using two self-developed items. Each item is assessed on a 5-point scale ranging from 0 ('No at all confident') to 4 ('Very confident'). A single overall score is calculated as the mean of the two items (possible range 0-4).
Time frame: 3 weeks post-randomization (Time 1)
Identification of COVID-19 vaccine information and misinformation, assessed using four items. Some items self-developed and some adapted from Hamel et al., 2021. Each item is assessed using a multiple choice (single answer) format. Each item response is scored as correct (value of '1') or incorrect (value of '0'). A single overall score is calculated as the sum of all four items (possible range 0-4).
Time frame: 3 weeks post-randomization (Time 1)
Trust in COVID-19 vaccine information given by different people and organizations, assessed using a list of three different sources. Each source is assessed using a 4-point scale ranging from 0 ('Not at all') to 3 ('A lot'). A single overall score is calculated as the mean of the three items (possible range 0-3).
Time frame: Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
Change in secondary outcomes from baseline, assessed using the same measures identified in Outcomes 3-13.
Time frame: Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
All primary and secondary outcomes assessed only for those who were exposed to their relevant study intervention and/or refresher intervention.
Time frame: Time of individual participants' exposure to intervention
Participants' exposure to the Dialogue-Based Webinar intervention assessed via webinar attendance data.
Time frame: Time of individual participants' exposure to intervention
Participants' exposure to the Social Media Website intervention assessed via website visit data.
Time frame: 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Likelihood of recommending the Dialogue-Based Webinar intervention to a coworker, assessed using a single-item adapted Net Promoter Score item.
Time frame: 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Likelihood of recommending the Social Media Website intervention to a coworker, assessed using a single-item adapted Net Promoter Score item.
Time frame: 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Likelihood of recommending the Centers for Disease Control and Prevention (CDC) website to a coworker, assessed using a single-item adapted Net Promoter Score item.
Dartmouth-Hitchcock Medical Center
Other
CONFIDENT: A Randomized Trial to Increase COVID-19 Vaccine Confidence in Long-term Care Workers
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