Clinical trial NCT01829256: Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
Official title: Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Diabetic Kidney Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

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

Primary outcomes:
measure: Change in kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys)
timeFrame: Measured at Baseline and again at 36 months
Secondary outcomes:
measure: Change in blood pressure, glucose/HbA1c and urine albumin
timeFrame: Measured at baseline and again at 36 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System Clinics
state: North Carolina
Study officials:
affiliation: Duke University
name: Hayden Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.