Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/9/2019 |
| Start Date: | May 2014 |
| End Date: | November 7, 2018 |
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
