- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542343
COVID-19 Risk Reduction Among African American Parishioners
January 17, 2023 updated by: Charles Drew University of Medicine and Science
Multilevel, Multidisciplinary, Faith-Based Participatory Interventions to Reduce COVID-19 Related-Risks Among Underserved African Americans
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90059
- Charles R. Drew University of Medicine & Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Risk Reduction of COVID-19 Among African American Parishioners
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.
|
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Improvement of Health Conditions Using the Severity of Medical Chronic Conditions Surveys
Time Frame: 3 months
|
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
|
3 months
|
Percentage of Participants Achieving Target Levels of Knowledge, Attitude, and Behaviors with NIH Toolbox Surveys
Time Frame: 3 months
|
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
|
3 months
|
Prevalence of COVID-19 testing using Participant COVID-19 Test History Survey
Time Frame: 3 months
|
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.
|
3 months
|
Prevalence of pneumococcal and influenza vaccinations using Participant Immunization History Survey
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
September 3, 2020
First Submitted That Met QC Criteria
September 4, 2020
First Posted (Actual)
September 9, 2020
Study Record Updates
Last Update Posted (Estimate)
January 19, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID19Church
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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