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

Not Applicable

Completed

• Conditions: Diabetes; Diabetic Kidney Disease; Hypertension
• Interventions: Behavioral: Pharmacist telehealth intervention

• Registration Number: NCT01829256
• Lead Sponsor: Duke University

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 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.

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.

Study Timeline

• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-11
• Study Start: 2014-05
• Primary Completion: 2018-11-07
• Study Completion: 2018-11-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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).

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist Telehealth Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys)	Measured at Baseline and again at 36 months

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure, glucose/HbA1c and urine albumin	Measured at baseline and again at 36 months

Trial Locations

Locations (1)

Duke University Health System Clinics; 🇺🇸 Durham, North Carolina, United States