Overview

This trial is active, not recruiting.

Conditions diabetes, hypertension, diabetic kidney disease
Treatment pharmacist telehealth intervention
Sponsor Duke University
Start date May 2014
End date October 2016
Trial size 285 participants
Trial identifier NCT01829256, Pro00044811

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
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.
pharmacist telehealth intervention
A tailored intervention with medication management and behavioral components. The behavioral modules may include, diet, exercise, weight, tobacco use, medication management, side effects, diabetes education, DKD/ HTN/ CVD risk and knowledge.Based on the patient's responses to a series of questions, there will be a provision of tailored feedback to reinforce evidence-based behavior for disease and lifestyle management.
(No Intervention)
Will receive educational material about management of kidney disease

Primary Outcomes

Measure
Change in kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys)
time frame: Measured at Baseline and again at 36 months

Secondary Outcomes

Measure
Change in blood pressure, glucose/HbA1c and urine albumin
time frame: Measured at baseline and again at 36 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)
Principal investigator Uptal Patel, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Duke University.