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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05168800
• Other study ID #: STUDY00032340
• Status: Completed
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: August 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2634
• Est. completion date: July 21, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Dialogue-Based Webinar
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 Website
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:
• Enhanced Usual Practice
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.

Locations

Country	Name	City	State
United States	Dartmouth College	Lebanon	New Hampshire

Sponsors (5)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	East Carolina University, Institute for Healthcare Improvement, National Association of Health Care Assistants, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dialogue-Based Webinar exposure	Participants' exposure to the Dialogue-Based Webinar intervention assessed via webinar attendance data.	Time of individual participants' exposure to intervention
Other	Social Media Website exposure	Participants' exposure to the Social Media Website intervention assessed via website visit data.	Time of individual participants' exposure to intervention
Other	Dialogue-Based Webinar acceptability	Likelihood of recommending the Dialogue-Based Webinar intervention to a coworker, assessed using a single-item adapted Net Promoter Score item.	3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Other	Social Media Website acceptability	Likelihood of recommending the Social Media Website intervention to a coworker, assessed using a single-item adapted Net Promoter Score item.	3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Other	Enhanced Usual Practice acceptability	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.	3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Primary	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'.	3 weeks post-randomization (Time 1)
Secondary	Change from baseline in COVID-19 vaccine confidence	Change in confidence in the COVID-19 vaccines from baseline, assessed using the 3-item Vaccine Confidence Index adapted for COVID-19.	Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
Secondary	Likelihood of recommending 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').	3 weeks post-randomization (Time 1)
Secondary	Likelihood of recommending 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').	3 weeks post-randomization (Time 1)
Secondary	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.	3 weeks post-randomization (Time 1)
Secondary	COVID-19 vaccine uptake (initial series completion)	Completion of initial COVID-19 vaccine series, assessed using two items with multiple choice (single answer) formats.	3 weeks post-randomization (Time 1)
Secondary	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.	3 weeks post-randomization (Time 1)
Secondary	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.	3 weeks post-randomization (Time 1)
Secondary	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.	3 weeks post-randomization (Time 1)
Secondary	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.	3 weeks post-randomization (Time 1)
Secondary	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').	3 weeks post-randomization (Time 1)
Secondary	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 (see https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-media-and-misinformation/). Each item is assessed using a multiple choice (single answer) format.	3 weeks post-randomization (Time 1)
Secondary	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').	3 weeks post-randomization (Time 1)
Secondary	Change from baseline in secondary outcomes	Change in secondary outcomes from baseline, assessed using the same measures identified in Outcomes 3-13.	Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
Secondary	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.	Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)