Clinical trial NCT05168800: CONFIDENT: Supporting Long-term Care Workers During COVID-19
Official title: CONFIDENT: A Randomized Trial to Increase COVID-19 Vaccine Confidence in Long-term Care Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Association of Health Care Assistants
name: Institute for Healthcare Improvement
name: East Carolina University
name: Patient-Centered Outcomes Research Institute
First posted: 2021-12-23
Enrollment: 2634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: COVID-19 vaccine confidence
timeFrame: 3 weeks post-randomization (Time 1)
Secondary outcomes:
measure: Change from baseline in COVID-19 vaccine confidence
timeFrame: Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
measure: Likelihood of recommending COVID-19 vaccination
timeFrame: 3 weeks post-randomization (Time 1)
measure: Likelihood of recommending COVID-19 booster vaccination to coworker
timeFrame: 3 weeks post-randomization (Time 1)
measure: COVID-19 vaccine uptake (any dose)
timeFrame: 3 weeks post-randomization (Time 1)
measure: COVID-19 vaccine uptake (initial series completion)
timeFrame: 3 weeks post-randomization (Time 1)
measure: COVID-19 vaccine uptake (booster completion)
timeFrame: 3 weeks post-randomization (Time 1)
measure: COVID-19 vaccine intent (initial series)
timeFrame: 3 weeks post-randomization (Time 1)
measure: COVID-19 vaccine intent (booster)
timeFrame: 3 weeks post-randomization (Time 1)
measure: COVID-19 vaccine intent (future vaccine recommendations)
timeFrame: 3 weeks post-randomization (Time 1)
measure: Feeling informed about the COVID-19 vaccines
timeFrame: 3 weeks post-randomization (Time 1)
measure: Identification of COVID-19 vaccine information and misinformation
timeFrame: 3 weeks post-randomization (Time 1)
measure: Trust in COVID-19 vaccine information from different sources
timeFrame: 3 weeks post-randomization (Time 1)
measure: Change from baseline in secondary outcomes
timeFrame: Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
measure: As-treated analyses of primary and secondary outcomes
timeFrame: Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
Other outcomes:
measure: Dialogue-Based Webinar exposure
timeFrame: Time of individual participants' exposure to intervention
measure: Social Media Website exposure
timeFrame: Time of individual participants' exposure to intervention
measure: Dialogue-Based Webinar acceptability
timeFrame: 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
measure: Social Media Website acceptability
timeFrame: 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
measure: Enhanced Usual Practice acceptability
timeFrame: 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Locations:
city: Lebanon
country: United States
facility: Dartmouth College
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Glyn Elwyn
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.