Integrated Population Program for Diabetic Kidney Disease
Completed · Not applicable
Conditions studied: Diabetic Kidney Disease, Uncontrolled Hypertension
In brief
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
Key facts
- Study ID
- NCT02418091
- Run by
- Duke University
- People needed
- 131
- Starts
- 2015-03-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2016-11-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Duke Clinical Research Institute — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.