search
Back to results

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

Primary Purpose

Diabetic Kidney Disease, Uncontrolled Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Kidney Disease focused on measuring patients with moderate DKD and uncontrolled HTN

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Telehealth

Control/No Intervention

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in Blood Pressure

Secondary Outcome Measures

Change in estimated Glomerular filtration rate (eGFR) for kidney function
Change in dietary habits as measured by questionnaire
Change in weight
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
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

Full Information

First Posted
March 20, 2015
Last Updated
November 18, 2016
Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT02418091
Brief Title
Integrated Population Program for Diabetic Kidney Disease
Acronym
STOP-DKD APP
Official Title
STOP-DKD Automated Population Program (APP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease, Uncontrolled Hypertension
Keywords
patients with moderate DKD and uncontrolled HTN

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Telehealth
Arm Type
Experimental
Arm 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.
Arm Title
Control/No Intervention
Arm Type
No Intervention
Arm Description
Group of subjects that will serve as a comparison group. These subjects will not be approached/enrolled for this study.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Blood Pressure
Time Frame
Baseline & 6months
Secondary Outcome Measure Information:
Title
Change in estimated Glomerular filtration rate (eGFR) for kidney function
Time Frame
Baseline & 6months
Title
Change in dietary habits as measured by questionnaire
Time Frame
Baseline & 6month
Title
Change in weight
Time Frame
Baseline & 6month
Title
Change in amount of physical activity as measured by questionnaire
Description
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
Time Frame
Baseline & 6month
Title
Change in taking medicine as prescribed
Description
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
Time Frame
Baseline& 6month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uptal Patel, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27715
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30964439
Citation
Lewinski AA, Patel UD, Diamantidis CJ, Oakes M, Baloch K, Crowley MJ, Wilson J, Pendergast J, Biola H, Boulware LE, Bosworth HB. Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention. J Med Internet Res. 2019 Apr 9;21(4):e12541. doi: 10.2196/12541.
Results Reference
derived

Learn more about this trial

Integrated Population Program for Diabetic Kidney Disease

We'll reach out to this number within 24 hrs