My Diabetes, My Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 512
- 试验地点
- 2
- 主要终点
- Mean Change in Percent of Hemoglobin A1C
研究概览
简要总结
Older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. Investigators will conduct a 12-month pragmatic clinical trial evaluating the impact of scalable interventions that are designed to support personalized goal setting and self-care through remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. This highly personalized approach to diabetes care has to potential to improve quality of life of this high-risk population while avoiding adverse drug events.
详细描述
To address the needs of older patients with diabetes, multiple organizations have called for a personalized approach to setting risk factor goals and self-care plans. The American Geriatrics Society (AGS) and the American Diabetes Association (ADA) have published recommendations urging individualized glycemic goals (hemoglobin A1C (A1C) <7.5%, <8.0%, or <8.5%) for three strata of older patients (healthy, complex, very complex). The guidelines also acknowledge the importance of addressing socioeconomic risks that are barriers to self-care management such as cost-related non-adherence and food insecurity. Despite widespread agreement by experts, the clinical impact of this highly personalized approach to diabetes care for older adults has been rarely studied in controlled trials. Interventions designed to personalize diabetes care must overcome multiple challenges to implementation including the brief clinical encounter, lack of patient engagement between encounters, and lack of systems to leverage community-based self-care resources.
Investigators propose to address these knowledge and care gaps by studying the integration of two evidence-based interventions designed to engage patients and enhance self-care:. Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL) and CommunityRx. The My Diabetes GOAL intervention is designed to engage older patients in personalized goal setting and chronic disease management.
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
- Single (Participant)
盲法说明
This will be a single-blind study, and subjects will blinded to the different group assignment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 2 diabetes
- •Seen in clinic within past year
- •Community dwelling
- •Access to personal email address OR internet access
- •Speaks and reads English
- •Resides in the target geographic region (zip codes)
排除标准
- •Unable to consent to study for themselves
- •Prior participation in CRxCaregiver, CRxHunger, or My Diabetes GOAL trials
结局指标
主要结局
Mean Change in Percent of Hemoglobin A1C
时间窗: Baseline to 12 months
Mean change in percent of hemoglobin A1C from baseline to month 12.
次要结局
- Number of Participants Who Achieved Personalized A1C Goals(Baseline to 12 months)
- Number of Participants With Documentation of Diabetes Goal at Baseline and Month 12(Baseline to 12 months)
- Personalized A1C Goals(Baseline to Month 1 Call)
- Diabetes Empowerment Scale (DES)(Baseline to 12 months)