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

Primary Purpose

Diabetes, Hypertension, Diabetic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist telehealth intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Health System Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharmacist Telehealth Intervention

Education Control

Arm Description

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.

Will receive educational material about management of kidney disease

Outcomes

Primary Outcome Measures

Change in kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys)

Secondary Outcome Measures

Change in blood pressure, glucose/HbA1c and urine albumin

Full Information

First Posted
April 9, 2013
Last Updated
February 6, 2019
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01829256
Brief Title
Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
Acronym
STOP-DKD
Official Title
Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Diabetic Kidney Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist Telehealth Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Education Control
Arm Type
No Intervention
Arm Description
Will receive educational material about management of kidney disease
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist telehealth intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in blood pressure, glucose/HbA1c and urine albumin
Time Frame
Measured at baseline and again at 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayden Bosworth, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System Clinics
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35072046
Citation
Machen L, Davenport CA, Oakes M, Bosworth HB, Patel UD, Diamantidis C. Race, Income, and Medical Care Spending Patterns in High-Risk Primary Care Patients: Results From the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) Study. Kidney Med. 2021 Oct 26;4(1):100382. doi: 10.1016/j.xkme.2021.08.016. eCollection 2022 Jan.
Results Reference
derived
PubMed Identifier
32685766
Citation
Zullig LL, Oakes MM, McCant F, Bosworth HB. Lessons learned from two randomized controlled trials: CITIES and STOP-DKD. Contemp Clin Trials Commun. 2020 Jul 8;19:100612. doi: 10.1016/j.conctc.2020.100612. eCollection 2020 Sep. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100690.
Results Reference
derived
PubMed Identifier
31659655
Citation
Zullig LL, Jazowski SA, Davenport CA, Diamantidis CJ, Oakes MM, Patel S, Moaddeb J, Bosworth HB. Primary Care Providers' Acceptance of Pharmacists' Recommendations to Support Optimal Medication Management for Patients with Diabetic Kidney Disease. J Gen Intern Med. 2020 Jan;35(1):63-69. doi: 10.1007/s11606-019-05403-x. Epub 2019 Oct 28.
Results Reference
derived
PubMed Identifier
29649631
Citation
Diamantidis CJ, Bosworth HB, Oakes MM, Davenport CA, Pendergast JF, Patel S, Moaddeb J, Barnhart HX, Merrill PD, Baloch K, Crowley MJ, Patel UD. Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial. Contemp Clin Trials. 2018 Jun;69:28-39. doi: 10.1016/j.cct.2018.04.003. Epub 2018 Apr 10.
Results Reference
derived

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

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