Diabetic kidney disease (DKD) is the major cause of end-stage renal disease (ESRD) in the US. Although many people with diabetes develop DKD, approximately one in five have DKD with uncontrolled hypertension that increases their risk of ESRD, cardiovascular events, and death. These risks are likely reduced by simultaneously improving control of multiple risk factors. However, prior interventions have largely been conducted using costly face-to-face visits that limit widespread application and including homogenous international populations that limit generalizability to diverse US patients. In addition, these studies have been mostly tested in early or late DKD but have not targeted those with moderate DKD. Targeting this group with DKD and uncontrolled hypertension provides a window of opportunity to potentially optimize efficiency and impact by excluding those with stable disease and reducing the risks of ESRD, cardiovascular events and death before developing advanced DKD. We propose an innovative telehealth approach that has reduced antecedents of kidney disease, including poor blood pressure control, but has never been used to treat DKD. The Simultaneous risk factor control using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) Study is a 3- year randomized, controlled trial in 300 adults with moderate DKD and uncontrolled hypertension that will evaluate whether a multifactorial telehealth intervention reduces progression of DKD compared to an education control. A study pharmacist will deliver the intervention via monthly telephone calls that simultaneously address medication management and modify multiple risk factors through a combination of patient self-monitoring, behavioral therapies and education that optimizes adherence and self-efficacy. The primary outcome is change in estimated glomerular filtration rate after 3 years. Secondary outcomes include change in blood pressure, blood glucose, and urinary albumin excretion. Other analyses will evaluate differences in clinical endpoints (doubling of creatinine, dialysis, death, cardiovascular events, and composite), improved behaviors that affect hypertension control (medication adherence, diet, physical activity, weight control), and cardiovascular risks (lipid profiles, aspirin use, smoking cessation). We will also conduct cost-effectiveness analyses using a robust simulation model. To mitigate the growing burden of DKD in the US, these studies are designed to determine whether a potentially scalable, telehealth intervention effectively slows progression of DKD in a diverse, high-risk population and whether it is also cost-effective.

Public Health Relevance

: The growing epidemic of diabetes will cause more people to suffer from kidney failure. Treatments that effectively slow the loss of kidney function and that can be easily spread into practice are needed to help reduce the 50,000 new cases of diabetic kidney failure each year. A cost-effective, evidence- based, telehealth intervention may fill a voi in such treatment options.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
1R01DK093938-01A1
Application #
8505049
Study Section
Kidney, Nutrition, Obesity and Diabetes (KNOD)
Program Officer
Narva, Andrew
Project Start
2013-05-15
Project End
2018-04-30
Budget Start
2013-05-15
Budget End
2014-04-30
Support Year
1
Fiscal Year
2013
Total Cost
$682,611
Indirect Cost
$247,827
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Pálsson, Ragnar; Patel, Uptal D (2014) Cardiovascular complications of diabetic kidney disease. Adv Chronic Kidney Dis 21:273-80
Patel, Uptal D (2014) Outcomes after pediatric kidney transplantation improving: how can we do even better? Pediatrics 133:734-5