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

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).

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: Dialogue-Based Webinar; Behavioral: Social Media Website; Other: Enhanced Usual Practice

• Study Type: Interventional
• Enrollment (Actual): 2634
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dialogue-Based Webinar	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.; Other Names: Discussion Session
Experimental: Social Media Website	Behavioral: 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 Names: Social Site
Active Comparator: Enhanced Usual Practice	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.; Other Names: Online Information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Time 0); 3 weeks post-randomization (Time 1)
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.	Baseline (Time 0); 3 months post-randomization (Time 2)
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.	Baseline (Time 0); 6 months post-randomization (Time 3)
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'.	3 weeks post-randomization (Time 1)
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'.	3 weeks post-randomization (Time 1)
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)
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)
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)
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').	3 weeks post-randomization (Time 1)
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').	3 weeks post-randomization (Time 1)
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').	3 weeks post-randomization (Time 1)
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).	3 weeks post-randomization (Time 1)
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).	3 weeks post-randomization (Time 1)
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).	3 weeks post-randomization (Time 1)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialogue-Based Webinar Exposure	Participants' exposure to the Dialogue-Based Webinar intervention assessed via webinar attendance data.	Time of individual participants' exposure to intervention
Social Media Website Exposure	Participants' exposure to the Social Media Website intervention assessed via website visit data.	Time of individual participants' exposure to intervention
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)
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)
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)

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute; East Carolina University; Institute for Healthcare Improvement; National Association of Health Care Assistants
• Investigators: Principal Investigator: Glyn Elwyn, Dartmouth College

Publications and helpful links

General 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.
• 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/

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: STUDY00032340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified copy of participant-level data and essential analytic code will be made available to others for research purposes, via data sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No