Trial Outcomes & Findings for COVID-19 Risk Reduction Among African American Parishioners (NCT NCT04542343)
NCT ID: NCT04542343
Last Updated: 2024-05-22
Results Overview
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.
COMPLETED
NA
405 participants
3 months. The assessments were conducted immediately before the workshop (baseline) and repeated three months after to measure changes in preparedness.
2024-05-22
Participant Flow
Participant milestones
| Measure |
Aim 1: Faith-based Leadership
This arm involves a series of workshops aimed at enhancing faith-based leaders' understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
Aim 2: COVID-19 Health Ambassadors
This group is part of a community outreach program where selected individuals from partnered faith-based organizations are trained to act as health ambassadors. The intervention includes comprehensive training on COVID-19 health practices, with an emphasis on support for chronic disease management, medication adherence, psychosocial support and, compliance with personal and public safety measures.
|
Aim 3: Older African American Adults
This intervention is designed specifically for older African American adults, focusing on enhancing their ability to manage chronic conditions and navigate health-related challenges during the COVID-19 pandemic. The program includes educational workshops, personalized health management plans, and community support systems to assist older parishioners in maintaining their health and safety led by trained health ambassadors. Key aspects of the intervention include training on how to safely visit healthcare providers, manage medication refills, and understand the importance of preventative measures against COVID-19.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
46
|
152
|
|
Overall Study
COMPLETED
|
10
|
19
|
110
|
|
Overall Study
NOT COMPLETED
|
7
|
27
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Risk Reduction Among African American Parishioners
Baseline characteristics by cohort
| Measure |
Aim 1: Faith-based Leadership
n=10 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
Aim 2: COVID-19 Health Ambassadors
n=19 Participants
This group is part of the project's community outreach where selected individuals are trained to act as lay health advisors (health ambassadors). The intervention includes comprehensive training on COVID-19 health practices, with an emphasis on chronic disease management.
|
Aim 3: Older African American Adults
n=110 Participants
This intervention is tailored specifically for older adults within the church community, focusing on enhancing their ability to manage chronic conditions and navigate health-related challenges during the COVID-19 pandemic. The program includes educational workshops and personalized health management plans facilitated and supported by trained health ambassadors. These ambassadors directly assist older parishioners in understanding and applying preventive measures against COVID-19, safely managing medication refills, and ensuring safe visits to healthcare providers.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Aim 1: Faith-based Leadership
n=10 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
|---|---|
|
Mean Change in the Ability to Implement COVID-19 Health Guidelines Among African American Churches in South Los Angeles 3 Months After Workshop
|
3.00000 score on a scale of 1-5
Interval 2.246 to 3.754
|
PRIMARY outcome
Timeframe: 3 days from the start of the workshops (baseline) to completion of workshop training sessions.Population: Church leaders who participated in the pre and post-assessment of the COVID-19 training workshops on adoption of COVID-19 public health guidelines
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).
Outcome measures
| Measure |
Aim 1: Faith-based Leadership
n=10 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
|---|---|
|
Mean Change in COVID-19 Knowledge Among Faith-based Leaders After Educational Workshop
|
-3.30000 score on a scale of 1-5
Interval -4.256785 to -2.343215
|
PRIMARY outcome
Timeframe: 3 days from the start of the workshops (baseline) to completion of workshop training sessions.Population: Number of participants who attended at least two out of the three 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.
Outcome measures
| Measure |
Aim 1: Faith-based Leadership
n=19 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
|---|---|
|
Number of Faith-based COVID-19 Health Ambassadors Who Attended at Least 2 Out of the 3-Day Training Workshops
|
19 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Aim 1: Faith-based Leadership
n=19 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
|---|---|
|
Mean Change in Preparedness for COVID-19 Testing, Vaccination, and Health Promotion by Health Ambassadors After Training Workshop
|
-16.4 score on a scale
Interval -19.96 to -12.64
|
PRIMARY outcome
Timeframe: 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.Population: Total number of participants who filled/refilled at least one of their prescription(s).
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.
Outcome measures
| Measure |
Aim 1: Faith-based Leadership
n=110 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
|---|---|
|
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
|
80 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Aim 1: Faith-based Leadership
n=110 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
|---|---|
|
Total Number of Older Adult Parishioners Who Received at Least One COVID-19 Vaccine After 6 Months Intervention With Support From a Health Ambassador
|
107 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Aim 1: Faith-based Leadership
n=110 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
|---|---|
|
Mean Change in Healthcare Utilization Among Older Adult Parishioners After 6 Months Intervention With Support From a Health Ambassador
|
-0.21818 score on a scale
Interval -0.36828 to -0.06809
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Aim 1: Faith-based Leadership
n=110 Participants
This arm targets faith-based leaders and involves a series of workshops aimed at enhancing their understanding and communication skills regarding COVID-19 prevention and health safety measures. The training focuses on enabling leaders to effectively disseminate critical COVID-19 information within their communities.
|
|---|---|
|
Mean Change in COVID-19 Knowledge Among Parishioners After 6 Months Intervention With Support From a Health Ambassador
|
0.05623 score on a scale
Interval 0.00459 to 0.10788
|
Adverse Events
Aim 1: Faith-based Leadership
Aim 2: COVID-19 Health Ambassadors
Aim 3: Older African American Adults
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
DR. MOHSEN BAZARGAN
CHARLES R. DREW UNIVERSITY OF MEDICINE AND SCIENCE
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place