My Diabetes Care: A Pragmatic, Parallel-design, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 4
- 主要终点
- Change in Blood Glucose Control
研究概览
简要总结
The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care (MDC), to evaluate its effect on clinical outcomes.
详细描述
484 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 242 will be assigned to the intervention (My Diabetes Care) embedded within an existing patient web portal, My Health at Vanderbilt at Vanderbilt University Medical Center or Patient Gateway at Brigham and Women's Hospital. 242 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt or Patient Gateway without the My Diabetes Care (MDC) application. Potentially eligible patients will be invited to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap). Outcomes data will be collected from patients at four time points: baseline (T0), three-month follow-up (T1), three-month follow-up (T2), six-month follow-up (T3), and twelve-month follow-up (T4). At each time point, study participants will complete questionnaires electronically via email using REDCap, participants' hemoglobin A1C level will be assess via home A1C test kits, and participants' diabetes health data will be abstracted from their electronic health record. Participants will be randomized to the intervention or control arm after their baseline data is collected.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus
- •Age 18-75 years old
- •Currently taking at least one medication for diabetes
- •Be a patient at Vanderbilt University Medical Center (VUMC) or Brigham and Women's Hospital (BWH)
- •Able to speak and read in English or Spanish
- •Have reliable access to a smartphone, tablet, or computer with internet access
- •Active patient web portal account (My Health at Vanderbilt at VUMC or Patient Gateway at BWH)
排除标准
- •Receiving dialysis,
- •Pregnant or planning to become pregnant within the next year,
- •Living in a long-term care facility.
结局指标
主要结局
Change in Blood Glucose Control
时间窗: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Hemoglobin A1c will assessed using mail-in home HbA1c test kits and participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.
次要结局
- Change in Body Mass Index (BMI)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Usability of MyChart (for Control Group)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Diabetes Self-Care (Diabetes Medication Adherence)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Low Density Lipoprotein (LDL)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Blood Pressure Control(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Diabetes Self-Care (Exercise Adherence)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Urine Albumin-to-Creatinine Ratio(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Change in Diabetes Self-Care (General Diet Adherence)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
- Satisfaction/Usability of My Diabetes Care (for Intervention Group)(Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3))
研究者
William Martinez, MD, MS
Assistant Professor of Medicine
Vanderbilt University Medical Center