CoronavirusNCT04542343
COVID-19 Risk Reduction Among African American Parishioners
A study testing Change in knowledge, motivation, skills, resources in people with Coronavirus, run by Charles Drew University of Medicine and Science at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Change in knowledge, motivation, skills, resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles R. Drew University of Medicine & Science
Los Angeles, California, 90059
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronavirus
- Being tested
- Change in knowledge, motivation, skills, resources
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in knowledge, motivation, skills, resourcesBehavioural
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges.
| Study group | Role | What they receive |
|---|---|---|
| Risk Reduction of COVID-19 Among African American Parishioners | Experimental | 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. Receives: Behavioral: Change in knowledge, motivation, skills, resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in the Ability to Implement COVID-19 Health Guidelines Among African American Churches in South Los Angeles 3 Months After Workshop
This measure evaluates the readiness of African American church leaders in South Los Angeles to reopen their churches according to Federal and State COVID-19 guidelines. It specifically assesses their confidence and ability to implement safety protocols learned during the workshops, using the "Church Reopening Preparedness" construct of the Church Leaders' Pandemic Outreach \& Preparedness Scale (CLOPS) [Cronbach's alpha of 0.97]. This construct measures effectiveness on a Likert scale from 1 (strongly disagree) to 5 (strongly agree), reflecting how well leaders apply these protocols to ensure a safe worship environment. Higher Scores indicate effective readiness to implement safety measures. Lower Scores suggest areas where further training or planning is needed. Positive numbers indicate increases in preparedness to reopen faith-based organizations.
Measured: 3 months. The assessments were conducted immediately before the workshop (baseline) and repeated three months after to measure changes in preparedness.
Mean Change in COVID-19 Knowledge Among Faith-based Leaders After Educational Workshop
Church Leaders' Pandemic Outreach \& Preparedness Scale (CLOPS) is designed to assess the effectiveness of COVID-19 workshops in changing the preparedness of church leaders to reopen churches and to deepen their knowledge about COVID-19 (Cronbach's alpha of 0.97) . Positive mean differences indicate increases in preparedness to reopen these faith-based organizations. The general COVID-19 knowledge enhancement construct measures the increase in participants' understanding of COVID-19, including its transmission and preventive measures on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate an enhanced knowledge of COVID-19 (better outcome). Lower scores suggest gaps in workshop content or participant comprehension (worse outcome).
Measured: 3 days from the start of the workshops (baseline) to completion of workshop training sessions.
Number of Faith-based COVID-19 Health Ambassadors Who Attended at Least 2 Out of the 3-Day Training Workshops
The outcome measure was primarily determined by the count of health ambassadors' attendance in a minimum of two out of three training sessions (each session held daily). These 3-day sessions encompassed interactive discussions and informal knowledge assessments designed to ensure comprehension and retention of critical COVID-19 information. The informal assessments were diverse, including group discussions where participants articulated preventive measures against COVID-19, role-playing to exemplify how they would convey complex health information to various community demographics, particularly older adults with underlying health conditions, and impromptu Q\&A segments aimed at evaluating participants' understanding of essential topics and rectifying any misconceptions immediately.
Measured: 3 days from the start of the workshops (baseline) to completion of workshop training sessions.
Mean Change in Preparedness for COVID-19 Testing, Vaccination, and Health Promotion by Health Ambassadors After Training Workshop
This outcome measure assesses the effectiveness of COVID-19 workshops in changing ambassadors' preparedness across five key constructs, as defined in CLOPS, including discussing infection risks, changing attitudes towards testing, boosting motivation for vaccination, convincing vaccine-hesitant individuals, and supporting older parishioners in managing chronic conditions amid the pandemic. Each construct is evaluated using a Likert scale from 1 to 5, where higher scores reflect a high level of readiness and effectiveness in demonstrating strong persuasive abilities, communication skills, and a capacity to support healthcare needs. Conversely, lower scores pinpoint areas requiring enhanced training, additional resources, or improved strategies. The total score is the sum of all sub-scale scores and ranges from 5 to 25. A negative mean difference between combined construct scores indicates an increase in the post-workshop scores compared to the pre-workshop scores.
Measured: 3 days from the start of the workshops (baseline) to completion of workshop training sessions.
Total Number of Older Adult Parishioners Who Filled/Refilled at Least One of Their Prescription(s) After 6 Months Intervention With Support From a Health Ambassador
This measure assesses the total number of participants who successfully filled/refilled at least one medication at the end of the intervention. Older adult participants, with the help of health ambassadors, self-reported whenever they picked up a medication fill/refill from their pharmacy. Only participants with outstanding prescriptions were required to report. By this, the outcome seeks to evaluate the effectiveness of the intervention in enhancing medication management among older adults, particularly in navigating health-related challenges during the COVID-19 pandemic.
Measured: 6 months. The end of the intervention was marked by 6 months after the first scheduled meeting (baseline) between the health ambassador and older adult parishioners.
Total Number of Older Adult Parishioners Who Received at Least One COVID-19 Vaccine After 6 Months Intervention With Support From a Health Ambassador
Assessing the number of participants who had received at least one additional COVID-19 vaccine by the end of the intervention period with the aid of a health ambassador
Measured: 6 months. The end of the intervention was marked by 6 months after the first scheduled meeting (baseline) between the health ambassador and church members.
Mean Change in Healthcare Utilization Among Older Adult Parishioners After 6 Months Intervention With Support From a Health Ambassador
This measure examines the delay in healthcare utilization among study participants with an emphasis on understanding the effects of interventions aimed at reducing barriers to accessing primary care, specialty services, dental care, and medication fills. To quantify these delays, a scale called the Healthcare Utilization Delay Scale was created, incorporating four distinct constructs: delay in getting prescriptions filled or refilled, visiting primary care providers, receiving dental care, and visiting specialty services. Scores on the scale are from 0 (no delay in any service) to 4 (delay in all measured services). Higher scores indicate more delays in healthcare utilization, representing a worse outcome, whereas lower scores suggest fewer delays, indicating better access to healthcare services. A negative mean difference indicates reduction in healthcare utilization delay among parishioners (calculated as post- minus pre-intervention scores).
Measured: 6 months. The end of the intervention was marked by 6 months after the first scheduled meeting (baseline) between the health ambassador and church members.
Mean Change in COVID-19 Knowledge Among Parishioners After 6 Months Intervention With Support From a Health Ambassador
This outcome measure assesses the effectiveness of an intervention by health ambassadors designed to increase COVID-19 knowledge among older adult parishioners using a newly developed 19-item scale - COVID-19 Knowledge Scale (Cronbach alpha = 0.87).Each item on the scale assesses participants' understanding of key aspects of COVID-19, such as transmission methods, symptoms, prevention strategies, and treatment options, with responses recorded as binary (1 = correct or 0 = incorrect). The total knowledge score for each participant is derived by averaging the scores across all items, with potential scores ranging from 0 to 1 (actual average scores ranged from 0.10 to 1.0). Higher average scores on this scale indicate a better understanding of COVID-19, and improvements are reflected by a positive mean difference in scores before and after the intervention (calculated as post- minus pre-intervention scores).
Measured: 6 months. The end of the intervention was marked by 6 months after the first scheduled meeting (baseline) between the health ambassador and church members.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Jun 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Mohsen Bazargan, PhD, Principal investigator, Charles R. Drew University of Medicine & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542343
- Sponsor's protocol ID
- COVID19Church
- Other IDs
- 5U54MD007598-15
- Status last verified
- May 2024
- First submitted
- 3 Sep 2020
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel, Multidisciplinary, Faith-Based Participatory Interventions to Reduce COVID-19 Related-Risks Among Underserved African Americans
- ClinicalTrials.gov ID
- NCT04542343
- Acronym / sponsor ID
- COVID19Church
- Conditions
- Coronavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 22 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk Reduction of COVID-19 Among African American Parishioners | Experimental | Behavioral: Change in knowledge, motivation, skills, resourcesThis 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in knowledge, motivation, skills, resourcesProvide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges. | Behavioural | Risk Reduction of COVID-19 Among African American Parishioners |
Primary outcome
Mean Change in the Ability to Implement COVID-19 Health Guidelines Among African American Churches in South Los Angeles 3 Months After Workshop
Time frame: 3 months. The assessments were conducted immediately before the workshop (baseline) and repeated three months after to measure changes in preparedness.
This measure evaluates the readiness of African American church leaders in South Los Angeles to reopen their churches according to Federal and State COVID-19 guidelines. It specifically assesses their confidence and ability to implement safety protocols learned during the workshops, using the "Church Reopening Preparedness" construct of the Church Leaders' Pandemic Outreach \& Preparedness Scale (CLOPS) [Cronbach's alpha of 0.97]. This construct measures effectiveness on a Likert scale from 1 (strongly disagree) to 5 (strongly agree), reflecting how well leaders apply these protocols to ensure a safe worship environment. Higher Scores indicate effective readiness to implement safety measures. Lower Scores suggest areas where further training or planning is needed. Positive numbers indicate increases in preparedness to reopen faith-based organizations.
Mean Change in COVID-19 Knowledge Among Faith-based Leaders After Educational Workshop
Time frame: 3 days from the start of the workshops (baseline) to completion of workshop training sessions.
Church Leaders' Pandemic Outreach \& Preparedness Scale (CLOPS) is designed to assess the effectiveness of COVID-19 workshops in changing the preparedness of church leaders to reopen churches and to deepen their knowledge about COVID-19 (Cronbach's alpha of 0.97) . Positive mean differences indicate increases in preparedness to reopen these faith-based organizations. The general COVID-19 knowledge enhancement construct measures the increase in participants' understanding of COVID-19, including its transmission and preventive measures on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate an enhanced knowledge of COVID-19 (better outcome). Lower scores suggest gaps in workshop content or participant comprehension (worse outcome).
Number of Faith-based COVID-19 Health Ambassadors Who Attended at Least 2 Out of the 3-Day Training Workshops
Time frame: 3 days from the start of the workshops (baseline) to completion of workshop training sessions.
The outcome measure was primarily determined by the count of health ambassadors' attendance in a minimum of two out of three training sessions (each session held daily). These 3-day sessions encompassed interactive discussions and informal knowledge assessments designed to ensure comprehension and retention of critical COVID-19 information. The informal assessments were diverse, including group discussions where participants articulated preventive measures against COVID-19, role-playing to exemplify how they would convey complex health information to various community demographics, particularly older adults with underlying health conditions, and impromptu Q\&A segments aimed at evaluating participants' understanding of essential topics and rectifying any misconceptions immediately.
Mean Change in Preparedness for COVID-19 Testing, Vaccination, and Health Promotion by Health Ambassadors After Training Workshop
Time frame: 3 days from the start of the workshops (baseline) to completion of workshop training sessions.
This outcome measure assesses the effectiveness of COVID-19 workshops in changing ambassadors' preparedness across five key constructs, as defined in CLOPS, including discussing infection risks, changing attitudes towards testing, boosting motivation for vaccination, convincing vaccine-hesitant individuals, and supporting older parishioners in managing chronic conditions amid the pandemic. Each construct is evaluated using a Likert scale from 1 to 5, where higher scores reflect a high level of readiness and effectiveness in demonstrating strong persuasive abilities, communication skills, and a capacity to support healthcare needs. Conversely, lower scores pinpoint areas requiring enhanced training, additional resources, or improved strategies. The total score is the sum of all sub-scale scores and ranges from 5 to 25. A negative mean difference between combined construct scores indicates an increase in the post-workshop scores compared to the pre-workshop scores.
Total Number of Older Adult Parishioners Who Filled/Refilled at Least One of Their Prescription(s) After 6 Months Intervention With Support From a Health Ambassador
Time frame: 6 months. The end of the intervention was marked by 6 months after the first scheduled meeting (baseline) between the health ambassador and older adult parishioners.
This measure assesses the total number of participants who successfully filled/refilled at least one medication at the end of the intervention. Older adult participants, with the help of health ambassadors, self-reported whenever they picked up a medication fill/refill from their pharmacy. Only participants with outstanding prescriptions were required to report. By this, the outcome seeks to evaluate the effectiveness of the intervention in enhancing medication management among older adults, particularly in navigating health-related challenges during the COVID-19 pandemic.
Total Number of Older Adult Parishioners Who Received at Least One COVID-19 Vaccine After 6 Months Intervention With Support From a Health Ambassador
Time frame: 6 months. The end of the intervention was marked by 6 months after the first scheduled meeting (baseline) between the health ambassador and church members.
Assessing the number of participants who had received at least one additional COVID-19 vaccine by the end of the intervention period with the aid of a health ambassador
Mean Change in Healthcare Utilization Among Older Adult Parishioners After 6 Months Intervention With Support From a Health Ambassador
Time frame: 6 months. The end of the intervention was marked by 6 months after the first scheduled meeting (baseline) between the health ambassador and church members.
This measure examines the delay in healthcare utilization among study participants with an emphasis on understanding the effects of interventions aimed at reducing barriers to accessing primary care, specialty services, dental care, and medication fills. To quantify these delays, a scale called the Healthcare Utilization Delay Scale was created, incorporating four distinct constructs: delay in getting prescriptions filled or refilled, visiting primary care providers, receiving dental care, and visiting specialty services. Scores on the scale are from 0 (no delay in any service) to 4 (delay in all measured services). Higher scores indicate more delays in healthcare utilization, representing a worse outcome, whereas lower scores suggest fewer delays, indicating better access to healthcare services. A negative mean difference indicates reduction in healthcare utilization delay among parishioners (calculated as post- minus pre-intervention scores).
Mean Change in COVID-19 Knowledge Among Parishioners After 6 Months Intervention With Support From a Health Ambassador
Time frame: 6 months. The end of the intervention was marked by 6 months after the first scheduled meeting (baseline) between the health ambassador and church members.
This outcome measure assesses the effectiveness of an intervention by health ambassadors designed to increase COVID-19 knowledge among older adult parishioners using a newly developed 19-item scale - COVID-19 Knowledge Scale (Cronbach alpha = 0.87).Each item on the scale assesses participants' understanding of key aspects of COVID-19, such as transmission methods, symptoms, prevention strategies, and treatment options, with responses recorded as binary (1 = correct or 0 = incorrect). The total knowledge score for each participant is derived by averaging the scores across all items, with potential scores ranging from 0 to 1 (actual average scores ranged from 0.10 to 1.0). Higher average scores on this scale indicate a better understanding of COVID-19, and improvements are reflected by a positive mean difference in scores before and after the intervention (calculated as post- minus pre-intervention scores).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen Bazargan, PhD principal investigator
Charles R. Drew University of Medicine & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change in knowledge, motivation, skills, resources in people with Coronavirus, run by Charles Drew University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in the Ability to Implement COVID-19 Health Guidelines Among African American Churches in South Los Angeles 3 Months After Workshop (time frame: 3 months. The assessments were conducted immediately before the workshop (baseline) and repeated three months after to measure changes in preparedness.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.