Integrated Population Program for Diabetic Kidney Disease (STOP-DKD APP)

Duke University

Status: Completed

Conditions: Uncontrolled Hypertension; Diabetic Kidney Disease

Treatments: Behavioral: Telehealth

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02418091

1R34DK102166-01 (U.S. NIH Grant/Contract)

Pro00052081

Details and patient eligibility

About

This study will build a population management system Simultaneous risk factor control using Telehealth to slOw Progression of Diabetic Kidney Disease STOP-DKD Application STOP-DKD APP and conduct a 6-month controlled trial to compare reduction of blood pressure. In addition, the study will evaluate the feasibility of future large-scale intervention to slow diabetic kidney disease (DKD) DKD progression.

Aim 1: Identify patients with moderate DKD and uncontrolled hypertension (HTN) using existing electronic health record data in an integrated data warehouse (Southeastern Diabetes Initiative- SEDI) to screen all patients within SEDI.

Aim 2: Implement an intervention designed to slow progression of DKD and treat associated conditions in a high-risk population with moderate DKD and uncontrolled HTN using the STOP-DKD APP

• Primary Outcome: Test the hypothesis that patients who receive the intervention will have greater improvements in blood pressure as compared to a control group after 6 months
• Secondary Outcomes: Exploratory analyses to determine whether patients who receive the intervention will have less progression (defined as a smaller decrease in kidney function), and improved behaviors that affect HTN control and cardiovascular risk (medication adherence, diet, physical activity, and weight control) as compared to a control group after 6 months

Aim 3: Evaluate the STOP-DKD APP Study to guide large-scale implementation & dissemination

• Impact Evaluation: Assess the potential population impact of our intervention using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework
• Economic Evaluation: Conduct an economic evaluation using the Archimedes Model by estimating projected costs and quality-adjusted life-years

Enrollment: 131 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Potentially eligible patients will be identified using the existing SEDI (Southeastern Diabetes Initiative) data warehouse that pulls electronic health record data quarterly from ten different source systems in the four counties.

• Adults (age ≥18 and 75 years);
• Diagnosis of type 2 diabetes (ICD-9 codes 250.x0, 250.x2);
• Have at least 2 serum creatinine values available in the 3 prior years, separated by at least 3 months;
• Preserved kidney function (based upon the last year's eGFR average of between 45-90 ml/min/1.73m2, estimated by calculating an eGFR using the 4-variable Modification of Diet in Renal Disease study equation);
• Evidence of diabetic nephropathy (Either: 1. presence of macroalbuminuria; 2. history of microalbuminuria prior to ACE (angiotensin-converting enzyme) inhibitor or angiotensin receptor blocker (ARB) therapy; 3. previous documentation of diabetic retinopathy or laser therapy; 4. if only microalbuminuria and no #3, then urinalysis without hematuria, and no other renal etiologies [i.e., glomerulonephritis, polycystic kidney disease, membranous nephropathy, renal artery stenosis])
• Uncontrolled HTN (1y mean clinic SBP≥140 and/or DBP≥90).

Exclusion Criteria:

Patients who meet any one of the exclusion criteria will be excluded:

• 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)
• Diagnosis of life-threatening disease with death probable within 4 years.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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131 participants in 2 patient groups

Intervention Telehealth

Experimental group

Description:

Using Telehealth to slow progression of diabetic kidney disease automated population program identifies patients and engages them to optimize DKD medication adherence and health behaviors using 2-way communication via patient-selected technology (mobile/web-based applications, text messaging, interactive voice response, or e-mail) backed by case management via the phone for suboptimal control or health status. The STOP-DKDAutomated Population Program will deliver a tailored, multi-factorial intervention to address medication self-management and modify multiple risk factors simultaneously through a combination of patient self-monitoring, behavioral therapies and education that optimize adherence and self-efficacy.

Treatment:

Behavioral: Telehealth

Control/No Intervention

No Intervention group

Description:

Group of subjects that will serve as a comparison group. These subjects will not be approached/enrolled for this study.