Integrated Population Program for Diabetic Kidney Disease
Condition: Diabetic Kidney Disease; Uncontrolled Hypertension
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

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
    


Intervention name(s): Telehealth
Intervention type(s): Behavioral
Intervention description(s): Using Telehealth to slow progression of diabetic kidney disease automated population program identifies patients and engages them to optimize DKD medication adherence and health behaviors using 2-way communication via patient-selected technology (mobile/web-based applications, text messaging, interactive voice response, or e-mail) backed by case management via the phone for suboptimal control or health status. The STOP-DKDAutomated Population Program will deliver a tailored, multi-factorial intervention to address medication self-management and modify multiple risk factors simultaneously through a combination of patient self-monitoring, behavioral therapies and education that optimize adherence and self-efficacy.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: patients with moderate DKD and uncontrolled HTN