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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04542343
Other study ID # COVID19Church
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 30, 2022

Study information

Verified date January 2023
Source Charles Drew University of Medicine and Science
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Change in knowledge, motivation, skills, resources
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges.

Locations

Country Name City State
United States Charles R. Drew University of Medicine & Science Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Charles Drew University of Medicine and Science

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months
Primary 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 3 months
Primary 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. 3 months
Primary 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. 3 months
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