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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05676970
Other study ID # IRB938-24
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 30, 2028

Study information

Verified date February 2024
Source Xavier University of Louisiana.
Contact Sara Al-Dahir, PharmD, PhD
Phone 504525766
Email saaldah@xula.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a 24-30 month behavioral intervention study to assess the impact of enrolling individuals a clinical pharmacist run telehealth education focused on wellness and vaccination. Individuals will be randomized to either a wellness only model focusing on nutrition, diabetes and hypertension or a wellness model with a vaccination education component. All participants will complete individual and group based interventions. Individuals will be recruited from industries with high risk for COVID-19 and other respiratory illness infection, such as health workers, teachers aides and the food industry. We are recruiting individuals who identify as African-American, Hispanic, come from a semi-rural/rural community or have additional social determinants of health that indicate social vulnerability. The primary outcome is COVID-19 vaccine completion. The secondary outcome is influenza vaccine completion.


Description:

Individuals will be recruited using a community-based participatory research model to identify 525 patients to enter into an 24-30 month clinical pharmacist run, vaccine and health and wellness program delivered via Xavier's clinical pharmacy faculty trained in telehealth medicine using an individually randomized group treatment trial approach based upon industry of recruitment. Our recruitment will target enrollment of: 65% African-Americans, 10% Hispanic and 20% rural, with overlapping categories as necessary. Participants will be recruited from target high risk industries for COVID-19 infection: hospitality and food industry, plant workers, nurse's aides, teacher's aides and the beauty industries. Participants will complete a minimum of three individual visits and group informational visits. Both arms of the study will receive health and wellness visits. Only the vaccine intervention arm will receive the vaccine and counseling. Changes in vaccine hesitancy and monitoring for vaccine completion will occur by the clinical pharmacist via patient interviews and LinksĀ© access. The primary outcome will be completed COVID-19 vaccination series (primary series + applicable boosters). The secondary outcome will be completed influenza vaccine. Impact: The implications of this proposed project are to understand health related beliefs and behaviors related to vaccination and vaccine hesitancy in the context of a general health and wellness model. This intervention approach aims to decrease vaccine disparities among vulnerable individuals. It will provide data to develop strategies to improve vaccination, especially COVID-19 vaccination, in vulnerable communities using pharmacy students and pharmacists. This grant will facilitate training early stage investigators and diversify the health research workforce as the researchers are underrepresented minorities and women.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date December 30, 2028
Est. primary completion date December 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Incomplete vaccination defined as 1a. Incomplete COVID-19 vaccine series 1b. Incomplete COVID-19 booster 1c. Incomplete annual influenza 2. Adults aged 18 years to 55 years of age 3. Able to speak English 4. Currently employed or seeking training in target industries such as: healthcare, education, beauty, hospitality, food (culinary) and industrial plant workers. 5. Able to use Telehealth technology via tablet, cell phone, or computer Exclusion Criteria: 1. Individuals who have completed the COVID-19 vaccine series and boosters. 2. Individuals with documented allergy or reaction to COVID-19 or influenza vaccine 3. Individuals who are unable to give informed consent. 4. Individuals with diagnosis of immunosuppressive conditions such as cancer, lupus, rheumatoid arthritis, Crohn's disease, Ulcerative Colitis, primary immunodeficiency, or organ transplant recipients 5. Individuals diagnoses with congestive heart failure 6. Individuals diagnosed with any cardiac arrhythmia

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telehealth: Wellness and Vaccination
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.
TeleHealth: Wellness Only
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.

Locations

Country Name City State
United States Xavier University of Louisiana New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Xavier University of Louisiana.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary COVID-19 Vaccine Series Completion Questionnaire derived from Documented completion in immunization health record of primary COVID-19 vaccine series + COVID-19 Booster (Binary: Completed or not completed) 1 year
Primary COVID-19 Vaccine Series Completion Questionnaire derived from Documented completion in immunization health record of primary COVID-19 vaccine series + COVID-19 Booster (Binary: Completed or not completed) Through study completion, on average, two years
Secondary Influenza Vaccination Completion Questionnaire derived from Documented completion in immunization health record of annual influenza vaccine (per vaccine year) 1 year
Secondary Influenza Vaccination Completion Questionnaire derived from Documented completion in immunization health record of annual influenza vaccine (Binary: Completed or not completed) Through study completion, on average, two years
Secondary Vaccine Hesitancy Scale Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine (Binary: Completed or not completed) 1 year
Secondary Vaccine Hesitancy Scale Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine Through study completion, on average, two years
Secondary Change in Vaccine Hesitancy Scale Change from Baseline to Study Completion Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine Through study completion, on average, two years
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