Integrated Population Program for Diabetic Kidney Disease

Study Overview
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Brief Summary
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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

Official Title
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STOP-DKD Automated Population Program (APP)

Conditions
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Diabetic Kidney Disease, Uncontrolled Hypertension

Intervention / Treatment
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* Behavioral: Telehealth


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Telehealth<br>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. | Behavioral: Telehealth<br>* 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.<br>|
| No Intervention: Control/No Intervention<br>Group of subjects that will serve as a comparison group. These subjects will not be approached/enrolled for this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure |  | Baseline & 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in estimated Glomerular filtration rate (eGFR) for kidney function |  | Baseline & 6months | 
| Change in dietary habits as measured by questionnaire |  | Baseline & 6month | 
| Change in weight |  | Baseline & 6month | 
| Change in amount of physical activity as measured by questionnaire | Investigators will assess whether patients who receive the intervention will have improved behaviors that affect HTN control and cardiovascular risk ( physical activity) as compared to a control group after 6 months | Baseline & 6month | 
| Change in taking medicine as prescribed | Investigators will assess whether patients who receive the intervention will have improved behaviors that affect HTN control and cardiovascular risk (medication adherence) as compared to a control group after 6 months | Baseline& 6month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients with moderate DKD and uncontrolled HTN