Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04993326
Status:
WITHDRAWN
Last Update Posted:
2023-02-22
First Post:
2021-08-04
Brief Title:
Advancing DSMES and COVID-19 Prevention and Protection Through emPOWERed to Change Program
Sponsor:
Charles Drew University of Medicine and Science
Organization:
Charles Drew University of Medicine and Science
Study Overview
Official Title:
Advancing DSMES and COVID-19 Prevention and Protection Through emPOWERed to Change Program
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
African Americans AAPeople of Color POC are disproportionately impacted by COVID-19 to an extent not observed in other racialethnic subgroups People of color are uniquely affected because keeping diabetes under control - the best defense against COVID-19 - has become more difficult as the pandemic has disrupted medical care exercise and healthy eating routines which are already well-known challenges for the African American community Diabetes Self-Management Education and Support DSMSS facilitates the knowledge skills and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis Now given the implications of COVID-19 on the AAPOC diabetes community it is imperative to enhance DSMES with education about protection and prevention of COVID-19 To begin to solve this problem we will adapt and implement the emPOWERed to Change DSMES program to provide enhanced type 2 diabetes mellitus T2DM education with an additional emphasis on COVID-19 protection and prevention This study will employ Community Based Participatory Research methods and will be conducted virtually in the community setting The proposed hypothesis based on the Health Belief Model HBM and the Theory of Planned Behavior TPB is African Americans AAPeople of Color POC in Los Angeles County with type 2 diabetes mellitus T2DM randomized to participate in the emPOWERed to Change program N48 are more likely to demonstrate sustained glycemic control increase in knowledge and skills related behaviors and risk factors associated with T2DM and SARS-CoV-2 COVID-19 and increased compliance with prevention and vaccination as compared to those who are randomized to usual care N48 in this 12 week program We propose a randomized control study design among 96 participants with 48 assigned to an intervention group and 48 assigned to a control group This study will also explore the experience of the participants appraisal of knowledge and skills acquisition for DSMES to maintain T2DM control reduce complications and SARS-CoV-2 COVID-19 prevention and protection The ultimate goal is to design prospective larger behavioral studies SuRe first or R21 with a multi-centered intervention with other RTRN institutions to demonstrate the applicability of this approach specifically focusing on the AAPOC community
Detailed Description:
Several studies have shown that COVID-19 patients with co-existing diabetes were more likely to develop severe or critical disease conditions with more complications and had higher incidence rates of antibiotic therapy non-invasive and invasive mechanical ventilation and death Another important finding is that African Americans AAPeople of Color POC are disproportionately impacted by COVID-19 to an extent not observed in other racialethnic subgroups Diabetes Self-Management Education and Support DSMSS facilitates the knowledge skills and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis Now given the implications of COVID-19 on the AAPOC diabetes community it is imperative to enhance DSMES with education about protection and prevention of COVID-19 We will adapt and implement the emPOWERed to Change DSMES program to provide enhanced type 2 diabetes mellitus T2DM education with an additional emphasis on COVID-19 protection and prevention The proposed hypothesis based on the Health Belief Model HBM and the Theory of Planned Behavior TPB is African Americans AAPeople of Color POC in Los Angeles County with type 2 diabetes mellitus T2DM randomized to participate in the emPOWERed to Change program N48 are more likely to demonstrate sustained glycemic control increase in knowledge and skills related behaviors and risk factors associated with T2DM and SARS-CoV-2 COVID-19 and increased compliance with prevention and vaccination as compared to those who are randomized to usual care N48 in this 12 week program
Aim 1 to determine the efficacy of the emPOWERed to Change program on the knowledge and skills related to eating habits physical activity stress management and medication adherence in the AAPOC population with type 2 diabetes
Hypothesis we hypothesized that AAPOC participants randomized to the program will have 20 increased knowledge and skills related to eating habits physical activity stress management medication adherence and control of diabetes compared to those randomized to the usual care
Aim 2 to determine the effect of the emPOWERed to Change program on the knowledge related to T2DM and COVID-19 risk factors prevention of infection COVID-19 vaccines and access resources for vaccination and compliance with prevention and vaccination against COVID-19
Hypothesis we hypothesized that AAPOC participants randomized to the program will have 20 increase in knowledge related to T2DM and COVID-19 compliance with prevention and vaccination against COVID-19 compared to those randomized to the usual care
We propose a randomized control study design among 96 participants with 48 assigned to an intervention group and 48 assigned to a control group This study will also explore the experience of the participants appraisal of knowledge and skills acquisition for DSMES to maintain T2DM control reduce complications and SARS-CoV-2 COVID-19 prevention and protection The ultimate goal is to design prospective larger behavioral studies SuRe first or R21 with a multi-centered intervention with other RTRN institutions to demonstrate the applicability of this approach specifically focusing on the AAPOC community
The presence of diabetes mellitus hypertension and obesity significantly increases the risk for hospitalization and death in COVID-19 patients COVID-19 patients with diabetes were found to be more likely to develop severe or critical disease conditions with more complications and had higher incidence rates of antibiotic therapy non-invasive and invasive mechanical ventilation and death Zhang et al 2020 In light of these findings the potential that existing racial and ethnic disparities will be worsened and compounded by COVID-19 because African Americans continue to suffer a disproportionate burden of chronic diseases with more pronounced disparities in type 2 diabetes congestive heart failure and hypertension
Health disparities among AAs has continued and have shown to be perpetuated by the COVID-19 pandemic Californias death rate among African Americans is disproportionate as compared to representation in the population 10 mortality versus 6 population and even more disproportionate in some counties Specifically the data from Los Angeles County showed a 14 mortality rate among African Americans who make up 9 of the countys population Azar et al 2020 In the context of circumstances surrounding COVID-19 the California Health Care Foundation identifies this pandemic as a perfect storm of irrefutable evidence that people of color are caught in a web of social inequality Hernández 2020 DSMES is a crucial element in helping patients navigate and incorporate successful care into their daily lives It has been proven to instill lifestyle modifications which are directly associated with improved blood sugar control reduce risk of diabetes complications fewer hospitalizations lower diabetes related medical cost and to be cost-effective Some reports show that less than 38 of patients diagnosed with diabetes actually receive DSMES Torres Tiwari Movsas Carrasquillo Zonszein 2015 The proposed study and intervention seek to consider and begin to mitigate these confounding issues
As the COVID-19 pandemic appears to be ending among some populations research suggests that AAs continue to be severely impacted In communities that have higher percentages of AAs study findings indicate an association between negative COVID-19 health outcomes and AAs including higher prevalence and higher death rates In addition the data suggests that the odds of surviving the epidemic may correlate to poverty levels indicating that other at-risk minority populations affected by poverty may also be disproportionately affected Cyrus et al 2020 Snowden and Graaf 2021 report that there are greater African American COVID-induced challenges and suffering and COVID-19 threatens to perpetuate these differences
While it is understood that policies are fundamental to shifting the trajectory of the Diabetes epidemic and the COVID-19 pandemic we believe that COVID-19 education enhanced DSMES interventions are promising Moreover we believe that by incorporating community-based outreach testing and access to culturally competent educational interventions within African American communities hold great promise for increased protection and prevention against COVID-19 along with better T2DM outcomes This will in turn have a positive impact on some of the observed disparities This research project can provide the groundwork to further develop and implement DSMES that is easily accessible and less limiting than traditional DSMES programs for this population especially during a critical inflection point in the COVID-19 pandemic
Literature suggests digital technology is the next link to enhanced communication between providers and patients Patients with diabetes often report a variety of barriers to accessing DSMES especially issues with transportation and time commitments in attending on-site DSMES programs This online T2DM education program provides an alternative for those who are unable or unwilling to attend traditional DSMES While an online program does not replace the need for traditional DSMES or certified diabetes educators having onlineon-demand availability does provide an additional resource for providers to offer for educating patients with diabetes in self-management and COVID-19 prevention and protection education
The emPOWERed to Change program presents a unique novel and timely approach to DSMES with the enhancement of COVID-19 education The program leverages digital technology to better support patients It will be delivered virtually on-demand with culturally sensitive content and utilize mHealth and social media which has shown to be increasingly useful given the COVID-19 pandemic while capitalizing on the current trends of preferred engagement via technology for this population
The emPOWERed to change program also integrates support through the use of Social media This interaction provides an additional means for assisting patients with diabetes as it increases access to care provides tools for self-management and fosters support from others diagnosed with the same disease Kenny 2014 According to Power and Pitfalls of Social Media in Diabetes Care McMahon 2013 some individuals find extra value in interacting with their peers online as they may feel their provider lacks the ability to relate to them in the way other patients with diabetes can Providers report finding that when patients utilize social media for support they have become increasingly compliant with treatment recommendations and appear to sustain healthy lifestyle changes Cooper Kar 2014 These lifestyle changes include healthy eating and engaging in physical activity more often when these individuals have the support of their peers and these peers in many cases are available exclusively online Cooper Kar 2014 Also engagement of individuals with diabetes via social media has been shown to provide the foundation for patients modified treatment regimens McMahon 2013
While behavior modification plays an important role in controlling blood sugars the use of technology can support self-management techniques and behaviors helpful to patients self-monitoring their blood glucose levels Park Burford Nolan Hanlen 2016
Preliminary data from The Suga Project Foundations DSMES program led by Natalie Pauls PI has shown that the elements of the emPOWERed to Change program are effective at increasing knowledge about type 2 diabetes helping avoid risks of complication improved communication with healthcare providers and an overall increased sense of better well-being through stress management and peer support
Literature reviews by Cotter et al 2014 and Gabarron et al 2018 suggests that technology-enabled strategies provide a viable option for facilitating diabetes self-management however future research is needed on the use of web-based interventions in underserved communities which is what this study will attempt to begin examining
Study Design We propose a randomized controlled study design among 134 participants Through a simple randomization methodology half of participants will be randomized to an intervention program and usual care group The proposed hypothesis based on the Health Belief Model HBM and the Theory of Planned Behavior TPB is African Americans AAPeople of Color POC in Los Angeles County with type 2 diabetes mellitus T2DM who participate in the emPOWERed to Change program will demonstrate sustained glycemic control
HbA1c7 and increase in knowledge of the risk factors associated with T2DM and SARS-CoV-2 COVID-19 and increased adherence to medication and compliance with prevention and vaccination as compared to those in the usual care group
Aim 1 to determine the efficacy of the emPOWERed to Change program on the knowledge and skills related to eating habits physical activity stress management and medication adherence in the AAPOC population with type 2 diabetes
Hypothesis we hypothesized that AAPOC participants randomized to the program will have 20 increased knowledge and skills related to eating habits physical activity stress management medication adherence and control of diabetes compared to those randomized to the usual care
Aim 2 to determine the effect of the emPOWERed to Change program on the knowledge related to T2DM and COVID-19 risk factors prevention of infection COVID-19 vaccines and access resources for vaccination and compliance with prevention and vaccination against COVID-19
Hypothesis we hypothesized that AAPOC participants randomized to the program will have 20 increase in knowledge related to T2DM and COVID-19 compliance with prevention and vaccination against COVID-19 compared to those randomized to the usual care
We propose a randomized control study design among 96 participants with 48 assigned to an intervention group and 48 assigned to a control group This study will also explore the experience of the participants appraisal of knowledge and skills acquisition for DSMES to maintain T2DM control reduce complications and SARS-CoV-2 COVID-19 prevention and protection The ultimate goal is to design prospective larger behavioral studies SuRe first or R21 with a multi-centered intervention with other RTRN institutions to demonstrate the applicability of this approach specifically focusing on the AAPOC community
The presence of diabetes mellitus hypertension and obesity significantly increases the risk for hospitalization and death in COVID-19 patients COVID-19 patients with diabetes were found to be more likely to develop severe or critical disease conditions with more complications and had higher incidence rates of antibiotic therapy non-invasive and invasive mechanical ventilation and death Zhang et al 2020 In light of these findings the potential that existing racial and ethnic disparities will be worsened and compounded by COVID-19 because African Americans continue to suffer a disproportionate burden of chronic diseases with more pronounced disparities in type 2 diabetes congestive heart failure and hypertension
Health disparities among AAs has continued and have shown to be perpetuated by the COVID-19 pandemic Californias death rate among African Americans is disproportionate as compared to representation in the population 10 mortality versus 6 population and even more disproportionate in some counties Specifically the data from Los Angeles County showed a 14 mortality rate among African Americans who make up 9 of the countys population Azar et al 2020 In the context of circumstances surrounding COVID-19 the California Health Care Foundation identifies this pandemic as a perfect storm of irrefutable evidence that people of color are caught in a web of social inequality Hernández 2020 DSMES is a crucial element in helping patients navigate and incorporate successful care into their daily lives It has been proven to instill lifestyle modifications which are directly associated with improved blood sugar control reduce risk of diabetes complications fewer hospitalizations lower diabetes related medical cost and to be cost-effective Some reports show that less than 38 of patients diagnosed with diabetes actually receive DSMES Torres Tiwari Movsas Carrasquillo Zonszein 2015 The proposed study and intervention seek to consider and begin to mitigate these confounding issues
As the COVID-19 pandemic appears to be ending among some populations research suggests that AAs continue to be severely impacted In communities that have higher percentages of AAs study findings indicate an association between negative COVID-19 health outcomes and AAs including higher prevalence and higher death rates In addition the data suggests that the odds of surviving the epidemic may correlate to poverty levels indicating that other at-risk minority populations affected by poverty may also be disproportionately affected Cyrus et al 2020 Snowden and Graaf 2021 report that there are greater African American COVID-induced challenges and suffering and COVID-19 threatens to perpetuate these differences
While it is understood that policies are fundamental to shifting the trajectory of the Diabetes epidemic and the COVID-19 pandemic we believe that COVID-19 education enhanced DSMES interventions are promising Moreover we believe that by incorporating community-based outreach testing and access to culturally competent educational interventions within African American communities hold great promise for increased protection and prevention against COVID-19 along with better T2DM outcomes This will in turn have a positive impact on some of the observed disparities This research project can provide the groundwork to further develop and implement DSMES that is easily accessible and less limiting than traditional DSMES programs for this population especially during a critical inflection point in the COVID-19 pandemic
Literature suggests digital technology is the next link to enhanced communication between providers and patients Patients with diabetes often report a variety of barriers to accessing DSMES especially issues with transportation and time commitments in attending on-site DSMES programs This online T2DM education program provides an alternative for those who are unable or unwilling to attend traditional DSMES While an online program does not replace the need for traditional DSMES or certified diabetes educators having onlineon-demand availability does provide an additional resource for providers to offer for educating patients with diabetes in self-management and COVID-19 prevention and protection education
The emPOWERed to Change program presents a unique novel and timely approach to DSMES with the enhancement of COVID-19 education The program leverages digital technology to better support patients It will be delivered virtually on-demand with culturally sensitive content and utilize mHealth and social media which has shown to be increasingly useful given the COVID-19 pandemic while capitalizing on the current trends of preferred engagement via technology for this population
The emPOWERed to change program also integrates support through the use of Social media This interaction provides an additional means for assisting patients with diabetes as it increases access to care provides tools for self-management and fosters support from others diagnosed with the same disease Kenny 2014 According to Power and Pitfalls of Social Media in Diabetes Care McMahon 2013 some individuals find extra value in interacting with their peers online as they may feel their provider lacks the ability to relate to them in the way other patients with diabetes can Providers report finding that when patients utilize social media for support they have become increasingly compliant with treatment recommendations and appear to sustain healthy lifestyle changes Cooper Kar 2014 These lifestyle changes include healthy eating and engaging in physical activity more often when these individuals have the support of their peers and these peers in many cases are available exclusively online Cooper Kar 2014 Also engagement of individuals with diabetes via social media has been shown to provide the foundation for patients modified treatment regimens McMahon 2013
While behavior modification plays an important role in controlling blood sugars the use of technology can support self-management techniques and behaviors helpful to patients self-monitoring their blood glucose levels Park Burford Nolan Hanlen 2016
Preliminary data from The Suga Project Foundations DSMES program led by Natalie Pauls PI has shown that the elements of the emPOWERed to Change program are effective at increasing knowledge about type 2 diabetes helping avoid risks of complication improved communication with healthcare providers and an overall increased sense of better well-being through stress management and peer support
Literature reviews by Cotter et al 2014 and Gabarron et al 2018 suggests that technology-enabled strategies provide a viable option for facilitating diabetes self-management however future research is needed on the use of web-based interventions in underserved communities which is what this study will attempt to begin examining
Study Design We propose a randomized controlled study design among 134 participants Through a simple randomization methodology half of participants will be randomized to an intervention program and usual care group The proposed hypothesis based on the Health Belief Model HBM and the Theory of Planned Behavior TPB is African Americans AAPeople of Color POC in Los Angeles County with type 2 diabetes mellitus T2DM who participate in the emPOWERed to Change program will demonstrate sustained glycemic control
HbA1c7 and increase in knowledge of the risk factors associated with T2DM and SARS-CoV-2 COVID-19 and increased adherence to medication and compliance with prevention and vaccination as compared to those in the usual care group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None