STOP-DKD Automated Population Program (APP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Change in Blood Pressure
研究概览
简要总结
This study will build a population management system Simultaneous risk factor control using Telehealth to slOw Progression of Diabetic Kidney Disease STOP-DKD Application STOP-DKD APP and conduct a 6-month controlled trial to compare reduction of blood pressure. In addition, the study will evaluate the feasibility of future large-scale intervention to slow diabetic kidney disease (DKD) DKD progression.
Aim 1: Identify patients with moderate DKD and uncontrolled hypertension (HTN) using existing electronic health record data in an integrated data warehouse (Southeastern Diabetes Initiative- SEDI) to screen all patients within SEDI.
Aim 2: Implement an intervention designed to slow progression of DKD and treat associated conditions in a high-risk population with moderate DKD and uncontrolled HTN using the STOP-DKD APP
- Primary Outcome: Test the hypothesis that patients who receive the intervention will have greater improvements in blood pressure as compared to a control group after 6 months
- Secondary Outcomes: Exploratory analyses to determine whether patients who receive the intervention will have less progression (defined as a smaller decrease in kidney function), and improved behaviors that affect HTN control and cardiovascular risk (medication adherence, diet, physical activity, and weight control) as compared to a control group after 6 months
Aim 3: Evaluate the STOP-DKD APP Study to guide large-scale implementation & dissemination
- Impact Evaluation: Assess the potential population impact of our intervention using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework
- Economic Evaluation: Conduct an economic evaluation using the Archimedes Model by estimating projected costs and quality-adjusted life-years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- •Patients who meet any one of the exclusion criteria will be excluded:
- •No access to telephone
- •Not proficient in English
- •Nursing home/long-term care facility resident or receiving home health care
- •Impaired hearing/ speech/ vision
- •Participating in another trial (pharmaceutical or behavioral)
- •Planning to leave the area in the next 3 years
- •Pancreatic insufficiency or diabetes secondary to pancreatitis
- •Alcohol abuse (>14 alcoholic beverages/ wk)
- •Diagnosis of non-diabetic kidney disease
- •Active malignancy (other than non-melanomatous skin cancer)
- •Diagnosis of life-threatening disease with death probable within 4 years.
结局指标
主要结局
Change in Blood Pressure
时间窗: Baseline & 6months
次要结局
- Change in dietary habits as measured by questionnaire(Baseline & 6month)
- Change in taking medicine as prescribed(Baseline& 6month)
- Change in estimated Glomerular filtration rate (eGFR) for kidney function(Baseline & 6months)
- Change in weight(Baseline & 6month)
- Change in amount of physical activity as measured by questionnaire(Baseline & 6month)