Integrated Population Program for Diabetic Kidney Disease
NCT ID: NCT02418091
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2015-03-31
2016-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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Intervention 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.
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.
Control/No Intervention
Group of subjects that will serve as a comparison group. These subjects will not be approached/enrolled for this study.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Uptal Patel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Clinical Research Institute
Durham, North Carolina, United States
Countries
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References
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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.
Other Identifiers
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Pro00052081
Identifier Type: -
Identifier Source: org_study_id