Integrated Population Program for Diabetic Kidney Disease

Not Applicable

Completed

• Conditions: Diabetic Kidney Disease; Uncontrolled Hypertension
• Interventions: Behavioral: Telehealth

• Registration Number: NCT02418091
• Lead Sponsor: Duke University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Telehealth	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.

Primary Outcome Measures

Name	Time	Method
Change in Blood Pressure	Baseline & 6months

Secondary Outcome Measures

Name	Time	Method
Change in dietary habits as measured by questionnaire	Baseline & 6month
Change in taking medicine as prescribed	Baseline& 6month	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
Change in estimated Glomerular filtration rate (eGFR) for kidney function	Baseline & 6months
Change in weight	Baseline & 6month
Change in amount of physical activity as measured by questionnaire	Baseline & 6month	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

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States