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

NCT01829256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2019-02-07

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Hayden Bosworth, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-11-07
Completion
2018-11-07

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01829256 on ClinicalTrials.gov