search
Back to results

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

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialogue-Based Webinar
Social Media Website
Enhanced Usual Practice
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dartmouth College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Dialogue-Based Webinar

Social Media Website

Enhanced Usual Practice

Arm Description

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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.
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').
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').
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.
COVID-19 vaccine uptake (initial series completion)
Completion of initial COVID-19 vaccine series, assessed using two items with multiple choice (single answer) formats.
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.
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.
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.
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.
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').
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.
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').
Change from baseline in secondary outcomes
Change in secondary outcomes from baseline, assessed using the same measures identified in Outcomes 3-13.
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.

Full Information

First Posted
December 21, 2021
Last Updated
August 14, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Association of Health Care Assistants, Institute for Healthcare Improvement, East Carolina University, Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05168800
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
July 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Association of Health Care Assistants, Institute for Healthcare Improvement, East Carolina University, Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2634 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialogue-Based Webinar
Arm Type
Experimental
Arm Title
Social Media Website
Arm Type
Experimental
Arm Title
Enhanced Usual Practice
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Dialogue-Based Webinar
Other Intervention Name(s)
Discussion Session
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Media Website
Other Intervention Name(s)
Social Site
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Practice
Other Intervention Name(s)
Online Information
Intervention Description
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.
Primary Outcome Measure Information:
Title
COVID-19 vaccine confidence
Description
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'.
Time Frame
3 weeks post-randomization (Time 1)
Secondary Outcome Measure Information:
Title
Change from baseline in COVID-19 vaccine confidence
Description
Change in confidence in the COVID-19 vaccines from baseline, assessed using the 3-item Vaccine Confidence Index adapted for COVID-19.
Time Frame
Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
Title
Likelihood of recommending COVID-19 vaccination
Description
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').
Time Frame
3 weeks post-randomization (Time 1)
Title
Likelihood of recommending COVID-19 booster vaccination to coworker
Description
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').
Time Frame
3 weeks post-randomization (Time 1)
Title
COVID-19 vaccine uptake (any dose)
Description
Receipt of any does of a COVID-19 vaccine, assessed using a single item with multiple choice (single answer) format.
Time Frame
3 weeks post-randomization (Time 1)
Title
COVID-19 vaccine uptake (initial series completion)
Description
Completion of initial COVID-19 vaccine series, assessed using two items with multiple choice (single answer) formats.
Time Frame
3 weeks post-randomization (Time 1)
Title
COVID-19 vaccine uptake (booster completion)
Description
Receipt of a COVID-19 booster vaccine if initial series completed, assessed using a single item with multiple choice (single answer) format.
Time Frame
3 weeks post-randomization (Time 1)
Title
COVID-19 vaccine intent (initial series)
Description
Intent to get a COVID-19 vaccine if unvaccinated, assessed using a single item with multiple choice (single answer) format.
Time Frame
3 weeks post-randomization (Time 1)
Title
COVID-19 vaccine intent (booster)
Description
Intent to get a COVID-19 booster vaccine if not yet received, assessed using a single item with multiple choice (single answer) format.
Time Frame
3 weeks post-randomization (Time 1)
Title
COVID-19 vaccine intent (future vaccine recommendations)
Description
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.
Time Frame
3 weeks post-randomization (Time 1)
Title
Feeling informed about the COVID-19 vaccines
Description
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').
Time Frame
3 weeks post-randomization (Time 1)
Title
Identification of COVID-19 vaccine information and misinformation
Description
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.
Time Frame
3 weeks post-randomization (Time 1)
Title
Trust in COVID-19 vaccine information from different sources
Description
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').
Time Frame
3 weeks post-randomization (Time 1)
Title
Change from baseline in secondary outcomes
Description
Change in secondary outcomes from baseline, assessed using the same measures identified in Outcomes 3-13.
Time Frame
Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
Title
As-treated analyses of primary and secondary outcomes
Description
All primary and secondary outcomes assessed only for those who were exposed to their relevant study intervention and/or refresher intervention.
Time Frame
Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3)
Other Pre-specified Outcome Measures:
Title
Dialogue-Based Webinar exposure
Description
Participants' exposure to the Dialogue-Based Webinar intervention assessed via webinar attendance data.
Time Frame
Time of individual participants' exposure to intervention
Title
Social Media Website exposure
Description
Participants' exposure to the Social Media Website intervention assessed via website visit data.
Time Frame
Time of individual participants' exposure to intervention
Title
Dialogue-Based Webinar acceptability
Description
Likelihood of recommending the Dialogue-Based Webinar intervention to a coworker, assessed using a single-item adapted Net Promoter Score item.
Time Frame
3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Title
Social Media Website acceptability
Description
Likelihood of recommending the Social Media Website intervention to a coworker, assessed using a single-item adapted Net Promoter Score item.
Time Frame
3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)
Title
Enhanced Usual Practice acceptability
Description
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.
Time Frame
3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glyn Elwyn
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth College
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
27658738
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs