Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
Completed · Not applicable
Conditions studied: Diabetes, Hypertension, Diabetic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT01829256
- Run by
- Duke University
- People needed
- 285
- Starts
- 2014-05-01
- Expected to finish
- 2018-11-07
- Last updated by the study team
- 2019-02-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Duke University Health System Clinics — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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