Advancing DSME/S and COVID-19 Prevention and Protection Through "emPOWERed to Change" Program
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Type 2 Glycemic Control - HbA1c of 7% or less
研究概览
简要总结
African Americans (AA)/People of Color (POC) are disproportionately impacted by COVID-19 to an extent not observed in other racial/ethnic 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 (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. To begin to solve this problem 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. 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 (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. 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 and older African American, Male or Female, must be diagnosed with type 2 diabetes mellitus and be from MLK-OPC, no prior formal DSME/S program participation and must have internet access
排除标准
- •Under 18 years of age, POC but not African American, not diagnosed with type 2 diabetes mellitus, not a patient of LAC DHS MLK-OPC facilities, not having internet access, had or receiving formal DSME/S program
结局指标
主要结局
Type 2 Glycemic Control - HbA1c of 7% or less
时间窗: 12 weeks
Achieve Glycemic control defined as an HbA1c of 7% or less
次要结局
- Understand of COVID-19 Risks, Protection and Prevention(12 weeks)
- Understanding of Diabetes Self-Management(12 weeks)
