Completed

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

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What is being tested

Pharmacist telehealth intervention

Behavioral
Who is being recruted

Urogenital Diseases+13

+ Cardiovascular Diseases

+ Endocrine System Diseases

From 18 to 75 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: May 2014
See protocol details

Summary

Principal SponsorDuke University
Last updated: February 7, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2014

Actual date on which the first participant was enrolled.

A randomized, controlled trial to slow DKD progression: 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 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 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.

NCT01829256
Principal SponsorDuke University
Last updated: February 7, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

285 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesCardiovascular DiseasesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesUrologic DiseasesVascular DiseasesGlucose Metabolism DisordersDiabetes ComplicationsFemale Urogenital DiseasesMale Urogenital DiseasesDiabetes MellitusDiabetic NephropathiesHypertension

Criteria

7 inclusion criteria required to participate
age >= 18 and less than75 years
diagnosis of type 2 diabetes
evidence of diabetic nephropathy
have at least 2 serum creatinine values available in the 3 prior years, separated by at least 3 months
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16 exclusion criteria prevent from participating
Dementia
Long-term or chronic dialysis
Pregnancy, Breastfeeding
Renal Transplant
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

No Intervention
Will receive educational material about management of kidney disease

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Duke University Health System Clinics

Durham, United StatesOpen Duke University Health System Clinics in Google Maps
CompletedOne Study Center