Integrated Population Program for Diabetic Kidney Disease
- Conditions
- Diabetic Kidney DiseaseUncontrolled Hypertension
- Registration Number
- NCT02418091
- Lead Sponsor
- Duke University
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Blood Pressure Baseline & 6months
- Secondary Outcome Measures
Name Time Method Change in dietary habits as measured by questionnaire Baseline & 6month Change in taking medicine as prescribed Baseline& 6month Investigators will assess whether patients who receive the intervention will have improved behaviors that affect HTN control and cardiovascular risk (medication adherence) as compared to a control group after 6 months
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 Investigators will assess whether patients who receive the intervention will have improved behaviors that affect HTN control and cardiovascular risk ( physical activity) as compared to a control group after 6 months
Trial Locations
- Locations (1)
Duke Clinical Research Institute
🇺🇸Durham, North Carolina, United States
Duke Clinical Research Institute🇺🇸Durham, North Carolina, United States