Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) (STOP-DKD)
|ClinicalTrials.gov Identifier: NCT01829256|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : February 7, 2019
Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United States. The purpose of this study is to prevent progression of kidney disease among patients with DKD and uncontrolled hypertension (HTN) using a tailored, telehealth intervention that simultaneously address medication management and modifies multiple risk factors through a combination of patient self-monitoring, behavioral therapies and education to optimize adherence and self-efficacy. Additional goals are to improve control of cardiovascular disease risk factors and reduce cardiovascular events and death.
We hypothesize that patients with DKD and uncontrolled HTN who receive this intervention will have less progression, or a smaller decrease in kidney function, after 3 years when compared to the education control group.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Hypertension Diabetic Kidney Disease||Behavioral: Pharmacist telehealth intervention||Not Applicable|
A randomized, controlled trial to slow DKD progression:
- Using an innovative telehealth approach that is potentially scalable with demonstrable efficacy in reducing antecedents of kidney disease, including poor blood pressure, glucose, and lipid control
- Enrolling demographically diverse patients from local primary care clinics to allow applicability of our results to the general US population within existing delivery systems; and
- Targeting patients with moderate DKD (estimated glomerular filtration rate between 45-90 ml/min/1.73m2 with evidence of diabetic nephropathy) and uncontrolled HTN (blood pressure ≥140/90 mm Hg), accounting for about 20% of all patients with diabetes who disproportionately suffer from end-stage renal disease (ESRD), cardiovascular events, and death.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||285 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||November 7, 2018|
|Actual Study Completion Date :||November 7, 2018|
Experimental: Pharmacist Telehealth Intervention
Will receive a tailored multi-factorial clinical pharmacist-administered telehealth intervention, which includes medication management and behavioral-educational components. The intervention will occur monthly over 3 years.
Behavioral: Pharmacist telehealth intervention
A tailored intervention with medication management and behavioral components. The behavioral modules may include, diet, exercise, weight, tobacco use, medication management, side effects, diabetes education, DKD/ HTN/ CVD risk and knowledge.Based on the patient's responses to a series of questions, there will be a provision of tailored feedback to reinforce evidence-based behavior for disease and lifestyle management.
No Intervention: Education Control
Will receive educational material about management of kidney disease
- Change in kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys) [ Time Frame: Measured at Baseline and again at 36 months ]
- Change in blood pressure, glucose/HbA1c and urine albumin [ Time Frame: Measured at baseline and again at 36 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829256
|United States, North Carolina|
|Duke University Health System Clinics|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Hayden Bosworth, PhD||Duke University|