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Telehealth Education for Vaccine Hesitancy
N/A
Recruiting
Led By Klaus Heyer, PhD
Research Sponsored by Xavier University of Louisiana.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, on average, two years
Awards & highlights
Study Summary
This trial is assessing the impact of telehealth education on wellness and vaccinations for individuals at risk of COVID-19. Primary outcome is COVID-19 vaccine completion.
Who is the study for?
This trial is for adults aged 18-55 working in high-risk industries like healthcare, education, and food service. Participants should have incomplete COVID-19 or flu vaccinations, speak English, and be able to use telehealth tech. Those with severe allergies to vaccines, certain heart conditions, immunosuppressive diseases, or who've completed their COVID-19 vaccine series can't join.Check my eligibility
What is being tested?
The study tests a telehealth program run by clinical pharmacists focusing on wellness and vaccination education. Participants will either learn about general wellness or wellness plus vaccination over a period of up to 30 months through individual and group sessions. The goal is to see if this increases vaccine completion rates among at-risk workers.See study design
What are the potential side effects?
Since the interventions involve educational components rather than medical treatments or drugs, there are no direct side effects from the intervention itself. However, participants may experience discomfort with technology use or stress from discussing vaccinations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, on average, two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average, two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
COVID-19 Vaccine Series Completion
Secondary outcome measures
Change in Vaccine Hesitancy Scale
Influenza Vaccination Completion
Vaccine Hesitancy Scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Telehealth Arm: Wellness with Vaccine EducationExperimental Treatment1 Intervention
Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. In addition, they will complete education and counseling on vaccination. All educations will be completed one-on-one as well as small group.
Group II: Telehealth Arm: Wellness OnlyActive Control1 Intervention
Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. All educations will be completed one-on-one as well as small group.
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Who is running the clinical trial?
Xavier University of Louisiana.Lead Sponsor
6 Previous Clinical Trials
2,378 Total Patients Enrolled
1 Trials studying Vaccine Hesitancy
379 Patients Enrolled for Vaccine Hesitancy
Klaus Heyer, PhDPrincipal InvestigatorNunez Community College
1 Previous Clinical Trials
379 Total Patients Enrolled
1 Trials studying Vaccine Hesitancy
379 Patients Enrolled for Vaccine Hesitancy
Sara Al-Dahir, PhDPrincipal InvestigatorXavier University of Louisiana.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with congestive heart failure.I have been diagnosed with an irregular heartbeat.I am between 18 and 55 years old.I have not completed my COVID-19 or flu vaccinations.I am able to understand and agree to the study's procedures and risks.I have a condition that weakens my immune system, like cancer or lupus.I have received all my COVID-19 vaccines and boosters.
Research Study Groups:
This trial has the following groups:- Group 1: Telehealth Arm: Wellness with Vaccine Education
- Group 2: Telehealth Arm: Wellness Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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