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

NCT05168800 | Completed Results DMC

• 1 other identifier: STUDY00032340
• Study Type: interventional
• Target: 2,634
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (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'.

  3 weeks post-randomization (Time 1)

Secondary Outcomes (16)

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

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

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

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

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

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

• Net Promoter Score (COVID-19 Vaccination)

  3 weeks post-randomization (Time 1)

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

  3 weeks post-randomization (Time 1)

Other Outcomes (5)

• Dialogue-Based Webinar Exposure

  Time of individual participants' exposure to intervention

• Social Media Website Exposure

  Time of individual participants' exposure to intervention

• Dialogue-Based Webinar Acceptability

  3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)

Study Arms (3)

Dialogue-Based Webinar

EXPERIMENTAL

Behavioral: Dialogue-Based Webinar

Social Media Website

EXPERIMENTAL

Behavioral: Social Media Website

Enhanced Usual Practice

ACTIVE COMPARATOR

Other: Enhanced Usual Practice

Interventions

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.

Also known as: Discussion Session

Dialogue-Based Webinar

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.

Also known as: Social Site

Social Media Website

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.

Also known as: Online Information

Enhanced Usual Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Association of Health Care Assistants: collaborator
• Institute for Healthcare Improvement: collaborator
• East Carolina University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Dartmouth College

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (3)

• 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.

  PMID: 27658738 BACKGROUND

• 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/

  BACKGROUND

• 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.

  PMID: 36823559 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Glyn Elwyn
• Organization: Dartmouth College

glynelwyn@gmail.com

(603) 646-5623

Study Officials

• Glyn Elwyn

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: December 23, 2021
• Study Start: February 21, 2022
• Primary Completion: February 20, 2023
• Study Completion: September 20, 2023
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

US (1)