DEAP: Diabetes Engagement and Activation Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Change in A1C
研究概览
简要总结
The following are hypothesized:
- The Diabetes Engagement and Activation Platform (DEAP) can be integrated into primary care workflow to facilitate the care of patients with type 2 diabetes.
- The DEAP intervention will be feasible and acceptable to patients with type 2 diabetes.
- The DEAP intervention will enhance patient activation and improve type 2 diabetes self management and glucose control
详细描述
Aim 1: To evaluate how primary care practices adopt and integrate DEAP into routine workflow including identification of barriers and facilitators to support acceptable, feasible, and sustainable use of the system.
- Sub-aim 1.1: Measure the proportion of clinicians and care team members who engage patients through the DEAP intervention as well as the types of patient support activities they address; assess the representativeness of participating clinicians and care team members in relation to all practice staff; and assess how they integrated DEAP into the care of type 2 diabetes patients.
- Sub-aim 1.2: Assess how practices redesign workflow, overcome barriers, and enhance facilitators in order to integrate DEAP.
- Sub-aim 1.3: Determine processes for sustaining DEAP beyond the project funding period .
Aim 2: To compare, relative to usual care, the effectiveness of the DEAP intervention.
- Sub Aim 2.1: Measure the proportion and representativeness of eligible patients who choose to enroll; access the DEAP curriculum; complete the DEAP curriculum; and contact care team members. .
- Sub Aim 2.2: Compare the change in the average glycosylated hemoglobin (primary outcome), Body Mass Index, systolic blood pressure, and type 2 diabetes (T2D) medications and patient activation (secondary outcomes) from baseline to 3 months and from 3 to 6 months for patients randomized to DEAP versus usual care.
Sub Aim 2.3: Assess the clarity, readability and acceptability of the DEAP curricula materials for T2D patients enrolled in the intervention.
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
- Single (Participant)
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
- •Patients diagnosed with type 2 diabetes and A1C measure ≥ 8%;
- •English speaking;
- •Enrolled in the practice EHR linked patient portal.
排除标准
- •Patients without type 2 diabetes or with type 2 diabetes who have a A1C less than or equal to 7.9%;
- •Non-English speaking;
- •Patients not enrolled in the practice EHR linked patient portal;
- •Under 18 and over 75 years of age.
研究组 & 干预措施
Behavioral self-management
Eligible patients who are registered on the practice EHR linked portal will be invited to join the study. Following informed consent, enrollment and randomization, participants in the treatment group will receive the type 2 diabetes behavioral self-management education intervention; comprised of 9 modules derived from Medline Plus.
干预措施: Usual Care (Other)
Usual Care
Usual care includes whatever care and services the patient's clinical provides as well as generic type 2 diabetes education built into the patient's EHR linked portal.
结局指标
主要结局
Change in A1C
时间窗: From date of study enrollment A1C will be retrieved from electronic health record (EHR) at baseline, 3 and 6 months after enrollment. Data will continue to be collected at these intervals on all participants until target sample of 160 is complete.
The A1C test is a blood test that provides information about a person's average levels of blood glucose, also called blood sugar, over the past 3 months. The A1C test is sometimes called the hemoglobin A1c, HbA1c, or glycohemoglobin test.
次要结局
- Blood Pressure (BP)(From date of study enrollment BP will be retrieved from EHR at baseline, 3 and 6 months following enrollment. Data will continue to be collected at these intervals on all participants until target sample of 160 is complete.)
- Patient Activation Measure (PAM 10)(From date of study enrollment PAM 10 will be retrieved from patient portal at baseline, 3 and 6 months following enrollment. Data will continue to be collected at these intervals on all participants until target sample of 160 is complete.)
- Body Mass Index (BMI)(From date of study enrollment BMI will be retrieved from EHR at baseline, three and six months following enrollment. Data will continue to be collected at these intervals on all participants until target sample of 160 is complet)