COVID-19 Risk Reduction Among African American Parishioners
Primary Purpose
Coronavirus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Change in knowledge, motivation, skills, resources
Sponsored by
About this trial
This is an interventional supportive care trial for Coronavirus
Eligibility Criteria
Inclusion Criteria:
- African American older adults aged 55 years with a chronic medical condition or 65years and older
- Have at least one risk factor for COVID-19
Exclusion Criteria:
- Resident of care facility
- Cognitive deficit (identified by short version of mini-mental instrument)
- Does not self-identify as African American and/or Black
- Under the age of 55years
- Unable to speak and/or read English
Sites / Locations
- Charles R. Drew University of Medicine & Science
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Risk Reduction of COVID-19 Among African American Parishioners
Arm Description
This arm will implement "one group pretest-posttest" design to improve COVID associated health outcomes of AA older parishioners in collaboration with trained young church-based health educators.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Improvement of Health Conditions Using the Severity of Medical Chronic Conditions Surveys
From pre-intervention to three-month post-intervention, a 30% change is anticipated for chronic physical and mental disease management among African American older adults
Percentage of Participants Achieving Target Levels of Knowledge, Attitude, and Behaviors with NIH Toolbox Surveys
From pre-intervention to three-month post-intervention, an 80% change is anticipated in knowledge, attitude, and behaviors of COVID-19 risk among African American older adults
Prevalence of COVID-19 testing using Participant COVID-19 Test History Survey
From pre-intervention to three-month post-intervention, a 40% change is anticipated for COVID-19 testing among the population of African American Older adults.
Prevalence of pneumococcal and influenza vaccinations using Participant Immunization History Survey
From pre-intervention to three-month post-intervention, a 70% change is anticipated in uptake of pneumococcal and influenza vaccinations among the population of African American Older adults.
Secondary Outcome Measures
Full Information
NCT ID
NCT04542343
First Posted
September 3, 2020
Last Updated
January 17, 2023
Sponsor
Charles Drew University of Medicine and Science
1. Study Identification
Unique Protocol Identification Number
NCT04542343
Brief Title
COVID-19 Risk Reduction Among African American Parishioners
Official Title
Multilevel, Multidisciplinary, Faith-Based Participatory Interventions to Reduce COVID-19 Related-Risks Among Underserved African Americans
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles Drew University of Medicine and Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
African American adults, specifically those managing chronic disease and social isolation, are one of the most vulnerable groups susceptible to COVID-19. This intervention involves a multi-disciplinary and culturally sensitive approach to address two major COVID-19 related challenges in this population. First, this program collaborates with predominantly African American churches to implement Federal and State guidelines aimed at preventing outbreaks of COVID-19 at faith-based gatherings. Second, this program trains church-based health advisors to help African American older parishioners manage their chronic health conditions and reduce psychological distress during the pandemic.
Detailed Description
To jointly implement and evaluate a telehealth-based, multidisciplinary, culturally-sensitive intervention with 265 AA older parishioners: (i) To mitigate the negative impact of COVID-19 on the management of chronic health conditions, and (ii) to reduce healthcare avoidance behaviors and psychological distress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risk Reduction of COVID-19 Among African American Parishioners
Arm Type
Experimental
Arm Description
This arm will implement "one group pretest-posttest" design to improve COVID associated health outcomes of AA older parishioners in collaboration with trained young church-based health educators.
Intervention Type
Behavioral
Intervention Name(s)
Change in knowledge, motivation, skills, resources
Intervention Description
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Improvement of Health Conditions Using the Severity of Medical Chronic Conditions Surveys
Description
From pre-intervention to three-month post-intervention, a 30% change is anticipated for chronic physical and mental disease management among African American older adults
Time Frame
3 months
Title
Percentage of Participants Achieving Target Levels of Knowledge, Attitude, and Behaviors with NIH Toolbox Surveys
Description
From pre-intervention to three-month post-intervention, an 80% change is anticipated in knowledge, attitude, and behaviors of COVID-19 risk among African American older adults
Time Frame
3 months
Title
Prevalence of COVID-19 testing using Participant COVID-19 Test History Survey
Description
From pre-intervention to three-month post-intervention, a 40% change is anticipated for COVID-19 testing among the population of African American Older adults.
Time Frame
3 months
Title
Prevalence of pneumococcal and influenza vaccinations using Participant Immunization History Survey
Description
From pre-intervention to three-month post-intervention, a 70% change is anticipated in uptake of pneumococcal and influenza vaccinations among the population of African American Older adults.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
African American older adults aged 55 years with a chronic medical condition or 65years and older
Have at least one risk factor for COVID-19
Exclusion Criteria:
Resident of care facility
Cognitive deficit (identified by short version of mini-mental instrument)
Does not self-identify as African American and/or Black
Under the age of 55years
Unable to speak and/or read English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen Bazargan, PhD
Organizational Affiliation
Charles R. Drew University of Medicine & Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles R. Drew University of Medicine & Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
12. IPD Sharing Statement
Learn more about this trial
COVID-19 Risk Reduction Among African American Parishioners
We'll reach out to this number within 24 hrs