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

February 6, 2019 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health System Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Education Control
Will receive educational material about management of kidney disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured at Baseline and again at 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in blood pressure, glucose/HbA1c and urine albumin
Time Frame: Measured at baseline and again at 36 months
Measured at baseline and again at 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Hayden Bosworth, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 7, 2018

Study Completion (Actual)

November 7, 2018

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00044811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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