Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Hypertension; Diabetic Kidney Disease
Intervention: Pharmacist telehealth intervention (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s): Uptal Patel, MD, Principal Investigator, Affiliation: Duke University
Overall contact: Megan McPhail, Phone: 919-668-0966, Email: megan.mcphail@dm.duke.edu
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.
Clinical Details
Official title: Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Primary outcome: Change in kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys)
Secondary outcome: Change in blood pressure, glucose/HbA1c and urine albumin
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Megan McPhail, Phone: 919-668-0966, Email: megan.mcphail@dm.duke.edu
Duke University Health System Clinics, Durham, North Carolina 27705, United States; Recruiting Megan McPhail Hayden B Bosworth, PhD, Sub-Investigator
Additional Information
Starting date: May 2014
Last updated: August 18, 2015
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