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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Duke University Identifier:
First received: April 9, 2013
Last updated: February 1, 2017
Last verified: February 2017

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 Intervention
Diabetic Kidney Disease
Behavioral: Pharmacist telehealth intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Health Services Research
Official Title: Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)

Resource links provided by NLM:

Further study details as provided by Duke University:

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

Enrollment: 285
Study Start Date: May 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
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Please refer to this study by its identifier: NCT01829256

United States, North Carolina
Duke University Health System Clinics
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Principal Investigator: Uptal Patel, MD Duke University
  More Information

Responsible Party: Duke University Identifier: NCT01829256     History of Changes
Other Study ID Numbers: Pro00044811
Study First Received: April 9, 2013
Last Updated: February 1, 2017

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases processed this record on April 28, 2017