The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The goal of this study is to evaluate the impact of a comprehensive diabetes education and management program based on frequent communication with patients using teleconsultation, text messaging, and phone calls on diabetes related outcomes in Latino patients with type 2 diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the baseline and the six-month visit will be at least 0.5 percent greater in the intervention group than in the control group.
详细描述
In this study participants will be followed for a period of 9 months. The control group will receive usual care during this period of time. While, the intervention group will be part of a diabetes education and management program lasting 6 months via a smartphone participants will receive. The 6 month intervention will be followed by a 3 month observation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have physician-diagnosed type 2 diabetes
- •Be self-identified as Hispanic or Latino
- •An A1c value between 8-14% within the last three months.
- •Demonstrate the ability, either alone or with the help of a family member that will be with the patient at least once a week, to use the technology that will be used during the teleconsultations
排除标准
- •Severe diabetes related chronic complications such as chronic renal failure, blindness, amputations, stroke, etc.
- •Concomitant chronic illnesses that would affect their participation in the program, i.e. cancer, debilitating diseases, etc.
- •Any other condition that would affect participant's basic mental health skills
- •Type 1 diabetes or gestational diabetes
- •Patients with abnormal hemoglobin, anemia or any condition that may affect red blood cell turnover. Any of these conditions may be detected through participants' history or through the laboratory report at study screening
- •Signs or symptoms of metabolic decompensation (polyuria, polydypsia, polyphagia, unexplained weight loss, blurry vision, lethargy, etc.)
研究组 & 干预措施
Control
Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care.
Intervention
Patients in this group will be part of a Virtual Diabetes Self-Care and Education Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months.
干预措施: Virtual Diabetes Self-Care and Education Program (Behavioral)
Intervention
Patients in this group will be part of a Virtual Diabetes Self-Care and Education Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months.
干预措施: Fitbit (Device)
Intervention
Patients in this group will be part of a Virtual Diabetes Self-Care and Education Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months.
干预措施: Smartphone (Device)
结局指标
主要结局
Hemoglobin A1c
时间窗: 9 months
The A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent.
次要结局
未报告次要终点