An interventional study of Change in knowledge, motivation, skills, resources in Coronavirus, sponsored by Charles Drew University of Medicine and Science. Completed at 1 site in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Charles Drew University of Medicine and Science · Not applicable, Interventional, and Supportive care
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.
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.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 405 is above the median of 107 across 541 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Charles Drew University of Medicine and Science is the lead sponsor of 41 studies on the registry; 1 is open to participants now.
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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.
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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
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.
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).
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.
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).
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.
| Milestone | Aim 1: Faith-based Leadership | Aim 2: COVID-19 Health Ambassadors | Aim 3: Older African American Adults |
|---|---|---|---|
| Started | 17 | 46 | 152 |
| Completed | 10 | 19 | 110 |
| Not completed | 7 | 27 | 42 |
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.
| score on a scale of 1-5 | Aim 1: Faith-based Leadership |
|---|---|
| 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 (2.24600 to 3.75400) |
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).
| score on a scale of 1-5 | Aim 1: Faith-Based Leadership |
|---|---|
| Mean Change in COVID-19 Knowledge Among Faith-based Leaders After Educational Workshop | -3.30000 (-4.256785 to -2.343215) |
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.
| Participants | Aim 2: COVID-19 Health Ambassadors |
|---|---|
| Number of Faith-based COVID-19 Health Ambassadors Who Attended at Least 2 Out of the 3-Day Training Workshops | 19 |
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.
| score on a scale | Aim 2: COVID-19 Health Ambassadors |
|---|---|
| Mean Change in Preparedness for COVID-19 Testing, Vaccination, and Health Promotion by Health Ambassadors After Training Workshop | -16.4 (-19.96 to -12.64) |
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.
| Participants | Aim 3: Older African American Adults |
|---|---|
| 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 |
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
| Participants | Aim 3: Older African American Adults |
|---|---|
| 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 |
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).
| score on a scale | Aim 3: Older African American Adults |
|---|---|
| Mean Change in Healthcare Utilization Among Older Adult Parishioners After 6 Months Intervention With Support From a Health Ambassador | -0.21818 (-0.36828 to -0.06809) |
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).
| score on a scale | Aim 3: Older African American Adults |
|---|---|
| Mean Change in COVID-19 Knowledge Among Parishioners After 6 Months Intervention With Support From a Health Ambassador | 0.05623 (0.00459 to 0.10788) |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aim 1: Faith-based Leadership | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Aim 2: COVID-19 Health Ambassadors | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Aim 3: Older African American Adults | 0/152 (0%) | 0/152 (0%) | 0/152 (0%) |
AIM1: Faith-based Leadership The arm consists of recruited faith-based leaders who play a pivotal role in community guidance and influence. Aim 2: COVID-19 Health Ambassadors Participants were recruited from various faith-based organizations showing interest in health advocacy. AIM 3: Older African American Adults The participants in this group are older adultswho are particularly vulnerable to COVID-19 and often face multiple challenges in managing chronic health conditions.
| Age, Categorical(Participants) | Aim 1: Faith-based Leadership | Aim 2: COVID-19 Health Ambassadors | Aim 3: Older African American Adults | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 10 | 29 | 43 |
| >=65 years | 6 | 9 | 81 | 96 |
| Sex: Female, Male(Participants) | Aim 1: Faith-based Leadership | Aim 2: COVID-19 Health Ambassadors | Aim 3: Older African American Adults | Total |
|---|---|---|---|---|
| Female | 2 | 15 | 77 | 94 |
| Male | 8 | 4 | 33 | 45 |
| Race (NIH/OMB)(Participants) | Aim 1: Faith-based Leadership | Aim 2: COVID-19 Health Ambassadors | Aim 3: Older African American Adults | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 19 | 110 | 139 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Charles Drew University of Medicine and Science