Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) (STOP-DKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01829256
Recruitment Status : Active, not recruiting
First Posted : April 11, 2013
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Duke University

April 9, 2013
April 11, 2013
February 22, 2018
May 2014
December 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01829256 on Archive Site
Change in blood pressure, glucose/HbA1c and urine albumin [ Time Frame: Measured at baseline and again at 36 months ]
Same as current
Not Provided
Not Provided
Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)

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.

A randomized, controlled trial to slow DKD progression:

  1. 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
  2. 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
  3. 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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Diabetes
  • Hypertension
  • Diabetic Kidney Disease
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.
  • 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.
    Intervention: Behavioral: Pharmacist telehealth intervention
  • No Intervention: Education Control
    Will receive educational material about management of kidney disease
Diamantidis CJ, Bosworth HB, Oakes MM, Davenport CA, Pendergast JF, Patel S, Moaddeb J, Barnhart HX, Merrill PD, Baloch K, Crowley MJ, Patel UD. Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial. Contemp Clin Trials. 2018 Jun;69:28-39. doi: 10.1016/j.cct.2018.04.003. Epub 2018 Apr 10.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age ≥18 and less than75 years
  • regular use of the Duke University Health System (≥2 primary care visits in 3 prior yrs)
  • diagnosis of type 2 diabetes
  • have at least 2 serum creatinine values available in the 3 prior years, separated by at least 3 months;
  • preserved kidney function (eGFR between 45-90 ml/min/1.73m2 on most recent creatinine)
  • evidence of diabetic nephropathy
  • uncontrolled HTN (1y mean clinic SBP≥140 and/or DBP≥90).

Exclusion Criteria:

  • 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)
  • life-threatening disease with death probable within 4 years
  • Secondary hypertension (renovascular disease, Cushing's syndrome, primary aldosteronism, pheochromocytoma, hypo-/hyperthyroidism, hyperparathyroidism, coarctation of the aorta)
  • Pregnancy, Breastfeeding
  • Long-term or chronic dialysis
  • Dementia
  • Renal Transplant
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Duke University
Duke University
Not Provided
Principal Investigator: Hayden Bosworth, PhD Duke University
Duke University
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP