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NCT02418091 · ClinicalTrials.gov registry record · NA
Integrated Population Program for Diabetic Kidney Disease
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 131
- Enrollment target
NCT02418091 is a NA study that has completed, run by Duke University. The registered enrollment target is 131 participants.
The verdict
NCT02418091, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 131 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Telehealth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02418091
The ClinicalTrials.gov registry entry for NCT02418091 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Telehealth is the first listed.
NCT02418091 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02418091 about?
NCT02418091 is a clinical study titled "Integrated Population Program for Diabetic Kidney Disease". 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 ...
What is the current status of trial NCT02418091?
This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2015-03. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02418091?
The interventions under investigation include: Telehealth (BEHAVIORAL).
Who is sponsoring clinical trial NCT02418091?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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