A Pilot Randomized Clinical Trial (RCT) to Examine the Benefits of a Culturally Adapted Peer Support and Self-Management Intervention to Improve Glycemic Control in African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in blood glucose (hemoglobin A1C)
研究概览
简要总结
The purpose of the study is to gather input about the value of adding a newly developed diabetes self-management program to an existing diabetes self-management program. Participants will self-identify as African-American/Black with type 2 diabetes, and prescribed a diabetes medication. Participants can expect to be in the study for 6 months.
详细描述
Both programs utilized in this study focus on topics such as diet, exercise, and stress. Both programs offer ideas to manage diabetes symptoms, discuss appropriate exercises, provide guidance on healthy eating, review the use of medicine, and offer tips on communicating with healthcare providers and voicing concerns to family members.
The new program is culturally-tailored for African Americans and focuses on helping patients take their medicines as prescribed.
The purpose of this research study is to evaluate this newly developed combined diabetes self-management program.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18-90 years old
- •Self-identify as African-American
- •Diagnosis of Type 2 diabetes
- •Able to speak/read English
- •Self-report having a primary care provider who prescribes one diabetes medication
- •Diagnosed with diabetes for ≥1 year at point of care
- •Will reside in the geographical area throughout the study period
- •Self-reported nonadherence on the DOSE-nonadherence survey
- •≥7.5% A1C
排除标准
- •Self-reported bipolar or personality disorders, schizophrenia, Alcohol and Other Drug Abuse (AODA), dementia
- •Older adults who have a history of severe hypoglycemia requiring medical assistance or glucagon administration
- •Participating in another lifestyle or medication adherence program
结局指标
主要结局
Change in blood glucose (hemoglobin A1C)
时间窗: Baseline, 2 months, 6 months
The hypothesis is that there will be a more significant change in mean A1C, which is clinically meaningful, for participants in Peers EXCEL as compared to those in HLWD.
次要结局
- Feasibility of intervention(Baseline, 2 months, 6 months)
- Medication adherence(Baseline, 2 months, 6 months)
- Acceptability of intervention(Baseline, 2 months, 6 months)
- Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score(Baseline, 2 months, 6 months)