Integrated Population Program for Diabetic Kidney Disease
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 7/27/2016 |
| Start Date: | March 2015 |
| End Date: | August 2017 |
| Contact: | Tina Harding, RN, BSN |
| Email: | tina.harding@duke.edu |
| Phone: | 919-668-8430 |
STOP-DKD Automated Population Program (APP)
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
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
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.
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