Advancing DSME/S and COVID-19 Prevention and Protection Through "emPOWERed to Change" Program

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 (AA)/People of Color (POC) are
disproportionately impacted by COVID-19 to an extent not observed in other racial/ethnic
subgroups. Diabetes Self-Management Education and Support (DSMS/S) 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 AA/POC diabetes community, it
is imperative to enhance DSME/S with education about protection and prevention of COVID-19.
We will adapt and implement the "emPOWERed to Change" DSME/S 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 (AA)/People of Color (POC) in Los Angeles
County with type 2 diabetes mellitus (T2DM) randomized to participate in the "emPOWERed to
Change" program (N=48) 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 (N=48) 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 AA/POC population with type 2 diabetes.

Hypothesis: we hypothesized that AA/POC 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 AA/POC 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 DSME/S 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 AA/POC 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. California's 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 county's 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) DSME/S 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 DSME/S (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
DSME/S 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 DSME/S that is easily accessible and less
limiting than traditional DSME/S 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 DSME/S, especially issues with transportation and time commitments in attending
on-site DSME/S programs. This online T2DM education program provides an alternative for those
who are unable or unwilling to attend traditional DSME/S. While an online program does not
replace the need for traditional DSME/S or certified diabetes educators, having
online/on-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 DSME/S 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 Foundation's DSME/S 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
(AA)/People 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.

(HbA1c<7%) 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.