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Completed

NCT Number: NCT05168800

CONFIDENT: Supporting Long-term Care Workers During COVID-19

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth College

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 18 years of age
  • can read, write, and understand English
  • lives in the United States
  • has worked in a long-term care setting in the past two years
  • can provide information to confirm they have worked in a long-term care setting
  • is not pregnant or breastfeeding
  • at least somewhat worried about the COVID-19 vaccines and/or has not received a COVID-19 vaccine booster shot

Exclusion criteria

  • under 18 years of age
  • cannot read, write, and understand English
  • does not live in the United States
  • has not worked in a long-term care setting in the past two years
  • cannot provide information to confirm they have worked in a long-term care setting
  • is pregnant or breastfeeding
  • less than somewhat worried about the COVID-19 vaccines and has received at least one COVID-19 vaccine booster shot

Treatment and study plan

Dialogue-Based Webinar

Behavioral

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

Social Media Website

Behavioral

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

Enhanced Usual Practice

Other

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

Primary outcomes

  1. COVID-19 Vaccine Confidence

    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'.

Secondary outcomes

  1. Change From Baseline to 3 Weeks Post-randomization in COVID-19 Vaccine Confidence

    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.

  2. Change From Baseline to 3 Months Post-randomization in COVID-19 Vaccine 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.

  3. Change From Baseline to 6 Months Post-randomization in COVID-19 Vaccine 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.

  4. Net Promoter Score (COVID-19 Vaccination)

    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'.

  5. Net Promoter Score (COVID-19 Booster Vaccination to Coworker)

    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'.

  6. COVID-19 Vaccine Uptake (Any Dose)

    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.

  7. COVID-19 Vaccine Uptake (Initial Series Completion)

    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.

  8. COVID-19 Vaccine Uptake (Booster Completion)

    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.

  9. COVID-19 Vaccine Intent (Initial Series)

    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').

  10. COVID-19 Vaccine Intent (Booster)

    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').

  11. COVID-19 Vaccine Intent (Future Vaccine Recommendations)

    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').

  12. Feeling Informed About the COVID-19 Vaccines

    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).

  13. Identification of COVID-19 Vaccine Information and Misinformation

    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).

  14. Trust in COVID-19 Vaccine Information From Different Sources

    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).

  15. Change From Baseline in Secondary Outcomes

    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.

  16. As-treated Analyses of Primary and Secondary Outcomes

    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.

Other outcomes

  1. Dialogue-Based Webinar Exposure

    Time frame: Time of individual participants' exposure to intervention

    Participants' exposure to the Dialogue-Based Webinar intervention assessed via webinar attendance data.

  2. Social Media Website Exposure

    Time frame: Time of individual participants' exposure to intervention

    Participants' exposure to the Social Media Website intervention assessed via website visit data.

  3. Dialogue-Based Webinar Acceptability

    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.

  4. Social Media Website Acceptability

    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.

  5. Enhanced Usual Practice Acceptability

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • East Carolina University
  • Institute for Healthcare Improvement
  • National Association of Health Care Assistants
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

CONFIDENT: A Randomized Trial to Increase COVID-19 Vaccine Confidence in Long-term Care Workers

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2021
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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