Status:
COMPLETED
Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
Lead Sponsor:
Duke University
Conditions:
Diabetes
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
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, i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2018
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT01829256
Start Date
May 1 2014
End Date
November 7 2018
Last Update
February 7 2019
Active Locations (1)
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1
Duke University Health System Clinics
Durham, North Carolina, United States, 27705