Integrated Population Program for Diabetic Kidney Disease

Diabetic Kidney Disease Clinical Trial

— STOP-DKD APP  

Official title:

STOP-DKD Automated Population Program (APP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418091
• Other study ID #: Pro00052081
• Secondary ID: 1R34DK102166-01
• Status: Completed
• Phase: N/A
• First received: March 20, 2015
• Last updated: November 18, 2016
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Hypertension
• Kidney Diseases
• Uncontrolled Hypertension

Intervention

Behavioral:
• Telehealth
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.

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood Pressure		Baseline & 6months	No
Secondary	Change in estimated Glomerular filtration rate (eGFR) for kidney function		Baseline & 6months	No
Secondary	Change in dietary habits as measured by questionnaire		Baseline & 6month	No
Secondary	Change in weight		Baseline & 6month	No
Secondary	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	No
Secondary	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	No