Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in HbA1C results at 12 weeks
研究概览
简要总结
In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.
详细描述
Participants in this study will take part in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, they will complete questionnaires that assess diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI will be collected. This data will also be collected again after the completion of the program. MedsPLUS Consulting are licensed pharmacists skilled in conducting biometric screenings and will assist in the collection of the clinical data. MedsPLUS Consulting will also be responsible for disposing of the biospecimens collected for the study through use of the SHARPS program.
In this study, DSMES participants will be randomly-assigned to one of two cohorts. One cohort will participate in the DSMES program and use remote patient monitoring (RPM) to track their health throughout the duration. Remote patient monitoring allows a participant's healthcare team to visualize and monitor health data outside of scheduled DSMES sessions. These participants will be given blood pressure and blood glucose tracking devices that utilize Bluetooth to automatically upload their health data into an RPM platform, Prevounce, once measurements are taken. The second cohort will also participate in the DSMES program but instead will be provided traditional blood pressure cuffs and glucometers that will not upload their data to a mobile platform to track their health data. These participants will use traditional means (paper trackers) to track their health data and will provide health updates during scheduled communication with the team. One community health worker (two total) will be assigned to each cohort to monitor the progress of the participants. These community health workers will contact participants outside of scheduled DSMES sessions to assess barriers that may hinder progress.The results of these interactions will be shared with MedsPLUS Consulting and the study team.
As a means of assessing the barriers for implementation for the entire faith-based DSMES program that incorporates RPM, DSMES participants, leadership from the faith-based organization, community health workers, and MedsPLUS Consulting will be asked to participate in focus groups or semi-structured interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Have a prior diabetes (Type 1, Type 2, or Gestational) or prediabetes diagnosis
- •Are aged 18 or older
- •Live in Jefferson County, Alabama
- •Have never participated in a DSMES program
排除标准
- •Not a resident of Jefferson County, Alabama
- •Completed a DSMES program
研究组 & 干预措施
Remote Patient Monitoring (RPM) Cohort
Utilizes remote patient monitoring platform to track blood pressure and blood glucose readings outside of DSMES sessions
干预措施: Remote Patient Monitoring in a Faith-Based Program (Behavioral)
Traditional Cohort
Utilizes paper trackers to track blood glucose and blood pressure readings outside of DSMES sessions
干预措施: Traditional Cohort Faith-based DSMES program (Behavioral)
结局指标
主要结局
Change from Baseline in HbA1C results at 12 weeks
时间窗: From enrollment to end of treatment at 12 weeks
HbA1C provides a person's average blood sugar over a 3 month period and will be measured at baseline and the end of the program via fingerprick test. The range of the test is from 4% to 14%. Normal ranges are from 4 to 5.6%, Prediabetes ranges are from 5.7% to 6.4%, Diabetes ranges are from 6.5% and above.
次要结局
- Change from Baseline in BMI at 12 weeks(From enrollment to end of treatment at 12 weeks)
- Change from Baseline in systolic blood pressure at 12 weeks(From baseline to the end of treatment at 12 weeks)
- Change from Baseline in Diastolic Blood Pressure at 12 weeks(From enrollment to the end of treatment at 12 weeks)
- Change from Baseline in Total Cholesterol at 12 weeks(From enrollment to the end of treatment at 12 weeks)
- Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at 12 weeks(From enrollment to the end of treatment at 12 weeks)
- Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at 12 weeks(From enrollment to the end of treatment at 12 weeks)
- Change from Baseline in Triglycerides at 12 weeks(From enrollment to the end of treatment at 12 weeks)
- Change from Baseline in Body Weight at 12 weeks(From enrollment to the end of treatment at 12 weeks)
研究者
Bertha Hidalgo
Associate Professor
University of Alabama at Birmingham