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COVID-19NCT05168800

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

A study testing Dialogue-Based Webinar, Social Media Website and Enhanced Usual Practice in people with COVID-19, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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
What is being tested?
Dialogue-Based Webinar, Social Media Website and Enhanced Usual Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,634 participants
Where
1 siteUnited States
Study dates
21 Feb 2022to 20 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dartmouth College

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

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

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).

Conditions
COVID-19
Being tested
Dialogue-Based Webinar, Social Media Website, Enhanced Usual Practice
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialogue-Based WebinarBehavioural

    Also called Discussion Session

    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.

  • Social Media WebsiteBehavioural

    Also called Social Site

    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.

  • Enhanced Usual PracticeOther

    Also called Online Information

    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.

Study groups in NCT05168800
Study groupRoleWhat they receive
Dialogue-Based WebinarExperimentalNot described
Receives: Behavioral: Dialogue-Based Webinar
Social Media WebsiteExperimentalNot described
Receives: Behavioral: Social Media Website
Enhanced Usual PracticeActive comparatorNot described
Receives: Other: Enhanced Usual Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COVID-19 Vaccine Confidence

    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'.

    Measured: 3 weeks post-randomization (Time 1)

Secondary outcomes (16)
  1. Change From Baseline to 3 Weeks Post-randomization in COVID-19 Vaccine Confidence

    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.

    Measured: Baseline (Time 0); 3 weeks post-randomization (Time 1)

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

    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.

    Measured: Baseline (Time 0); 3 months post-randomization (Time 2)

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

    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.

    Measured: Baseline (Time 0); 6 months post-randomization (Time 3)

  4. Net Promoter Score (COVID-19 Vaccination)

    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'.

    Measured: 3 weeks post-randomization (Time 1)

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

    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'.

    Measured: 3 weeks post-randomization (Time 1)

  6. COVID-19 Vaccine Uptake (Any Dose)

    Receipt of any does of a COVID-19 vaccine, assessed using a single item with multiple choice (single answer) format.

    Measured: 3 weeks post-randomization (Time 1)

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

    Completion of initial COVID-19 vaccine series, assessed using two items with multiple choice (single answer) formats.

    Measured: 3 weeks post-randomization (Time 1)

  8. COVID-19 Vaccine Uptake (Booster Completion)

    Receipt of a COVID-19 booster vaccine if initial series completed, assessed using a single item with multiple choice (single answer) format.

    Measured: 3 weeks post-randomization (Time 1)

  9. COVID-19 Vaccine Intent (Initial Series)

    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').

    Measured: 3 weeks post-randomization (Time 1)

  10. COVID-19 Vaccine Intent (Booster)

    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').

    Measured: 3 weeks post-randomization (Time 1)

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

    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').

    Measured: 3 weeks post-randomization (Time 1)

  12. Feeling Informed About the COVID-19 Vaccines

    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).

    Measured: 3 weeks post-randomization (Time 1)

  13. Identification of COVID-19 Vaccine Information and Misinformation

    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).

    Measured: 3 weeks post-randomization (Time 1)

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

    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).

    Measured: 3 weeks post-randomization (Time 1)

  15. Change From Baseline in Secondary Outcomes

    Change in secondary outcomes from baseline, assessed using the same measures identified in Outcomes 3-13.

    Measured: Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)

  16. As-treated Analyses of Primary and Secondary Outcomes

    All primary and secondary outcomes assessed only for those who were exposed to their relevant study intervention and/or refresher intervention.

    Measured: Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start21 Feb 2022
  3. Primary completion20 Feb 2023
  4. Study completion20 Sep 2023

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,634 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05168800
Sponsor's protocol ID
STUDY00032340
Status last verified
Jul 2025
First submitted
21 Dec 2021
Last updated
5 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified copy of participant-level data and essential analytic code will be made available to others for research purposes, via data sharing.

Publications

  • Larson HJ, de Figueiredo A, Xiahong Z, Schulz WS, Verger P, Johnston IG, Cook AR, Jones NS. The State of Vaccine Confidence 2016: Global Insights Through a 67-Country Survey. EBioMedicine. 2016 Oct;12:295-301. doi: 10.1016/j.ebiom.2016.08.042. Epub 2016 Sep 13.

    PubMed 27658738
  • Hamel L, Lopes L, Kirzinger A, Sparks G, Stokes M, Brodie M. KFF COVID-19 Vaccine Monitor: Media and Misinformation. 2021 Nov. Available at: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-media-and-misinformation/

  • Stevens G, Johnson LC, Saunders CH, Schmidt P, Sierpe A, Thomeer RP, Little NR, Cantrell M, Yen RW, Pogue JA, Holahan T, Schubbe DC, Forcino RC, Fillbrook B, Sheppard R, Wooten C, Goldmann D, O'Malley AJ, Dube E, Durand MA, Elwyn G. The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines. BMC Public Health. 2023 Feb 23;23(1):384. doi: 10.1186/s12889-023-15266-x.

    PubMed 36823559

Questions about this trial

What is this clinical trial studying?

A study testing Dialogue-Based Webinar, Social Media Website and Enhanced Usual Practice in people with COVID-19, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

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 7 inclusion and 7 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: finished, as of the sponsor's last update on 5 Aug 2025. 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 United States. 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?

Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COVID-19 Vaccine Confidence (time frame: 3 weeks post-randomization (Time 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168800, which also lists 3 linked publications.

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 5 Aug 2025.

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Clinical Trial NCT05168800 | AzTrials