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Clinical Trial 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


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02418091
Study type Interventional
Source Duke University
Contact
Status Completed
Phase N/A
Start date March 2015
Completion date September 2016

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