Michigan Men's Diabetes Project 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Regimen Adherence
研究概览
简要总结
The Michigan Men's Diabetes Project 2 (MenD 2) is an 18-month pilot randomized clinical trial. We are looking to recruit 60 Black men with type 2 diabetes (need to have diagnosis for at least 6 months) that are over the age of 21. Interested participants need to be under the care of a physician for their diabetes, have access to reliable transportation for study activities, and be willing to participate in 4 health assessments where they will get their A1C, blood pressure, height, and weight measured and they will complete a survey. All participants will receive 10 hours of diabetes self-management education with a Certified Diabetes Care and Education Specialist. Participants randomized to the intervention arm will also be offered 6 months of monthly diabetes self-management support (DSMS) sessions with trained Peer Leaders who are also Black men with type 2 diabetes. After the 6 months of support, this group will transition into 6 months of ongoing support where they can continue DSMS and/or other diabetes related initiatives that are important to the group and chosen by the group. Due to the COVID-19 pandemic, DSME and DSMS sessions will likely be held via Zoom, ongoing support sessions have potential to be in person. The 4 health assessments will take place at baseline, 3-months, 9-months, and 15-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Black/African American males, age 21 years or older with diagnosis of T2D for six months, transportation to attend program activities, under the care of a physician for diabetes, and willing to attend group delivered sessions.
排除标准
- •We considered restricting eligibility to a higher-risk population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the proposed study sample will have an A1c ≥ 8%. Focusing on all older Black men with T2D allows us to cast a wide net for secondary prevention and public health impact.
研究组 & 干预措施
Peer led diabetes self-management support (PLDSMS)
Participants in the PLDSMS arm will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. This group will then transition into monthly 90-minute diabetes self-management support (DSMS) with trained peer leaders for 6 months. After the DSMS sessions, the group will transition into 6 months of ongoing support and will be encouraged to continue DSMS through initiatives that are important to them.
干预措施: Diabetes Self-Management Education (Behavioral)
Peer led diabetes self-management support (PLDSMS)
Participants in the PLDSMS arm will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. This group will then transition into monthly 90-minute diabetes self-management support (DSMS) with trained peer leaders for 6 months. After the DSMS sessions, the group will transition into 6 months of ongoing support and will be encouraged to continue DSMS through initiatives that are important to them.
干预措施: Peer Led Diabetes Self-Management Support (Behavioral)
Control Group
Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist.
干预措施: Diabetes Self-Management Education (Behavioral)
结局指标
主要结局
Change in Regimen Adherence
时间窗: baseline, 3-months, 9-months, 15-months
Survey data
Change in Hemoglobin A1c
时间窗: baseline, 3-months, 9-months, 15-months
Anthropometric/clinical data
Hemoglobin A1c
时间窗: baseline, 3-months, 9-months, 15-months
Anthropometric data/clinical data - Change in HbA1c. HbA1c was measured using the DCA 2000 point-of-care testing instrument. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Change in Diabetes Self-Management
时间窗: baseline, 3-months, 9-months, 15-months
Psychosocial survey data collection (self-reported). Diabetes self-management was measured using the 8-item Perceived Diabetes Self-Management Scale (PDSMS), with summed scores ranging from 8 to 40 and higher scores representing greater self-effectiveness. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
次要结局
- Change in Body Mass Index(baseline, 3-months, 9-months, 15-months)
- Change in Blood Pressure(baseline, 3-months, 9-months, 15-months)
- Change in Diabetes-Related Distress(baseline, 3-months, 9-months, 15-months)
- Change in Diabetes Quality of Life(baseline, 3-months, 9-months, 15-months)
- Change in Adherence to gender norms(baseline, 3-months, 9-months, 15-months)
- Change in Depression(baseline, 3-months, 9-months, 15-months)
- Change in Diabetes Social Support(baseline, 3-months, 9-months, 15-months)
- Change in BMI(baseline, 3-months, 9-months, 15-months)
- Change in Blood Pressure (Systolic)(baseline, 3-months, 9-months, 15-months)
- Change in Blood Pressure (Diastolic)(baseline, 3-months, 9-months, 15-months)
- Change in Diabetes-Related Distress (Core)(baseline, 3-months, 9-months, 15-months)
- Change in Conformity to Masculine Norms(baseline, 3-months, 9-months, 15-months)
研究者
Jaclynn Hawkins
Assistant Professor
University of Michigan