We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov 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

Brief Summary:

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
Diabetes Hypertension Diabetic Kidney Disease Behavioral: Pharmacist telehealth intervention

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in blood pressure, glucose/HbA1c and urine albumin [ Time Frame: Measured at baseline and again at 36 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
Duke University
Principal Investigator: Hayden Bosworth, PhD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01829256     History of Changes
Other Study ID Numbers: Pro00044811
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases