Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)

Study Overview
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Brief Summary
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The purpose of this study is to determine if the adoption of a chronic care model in conjunction with tele monitoring and case management can reduce the risk of death, hospitalization, emergency room visits, or admission to a skilled nursing facility in patients with chronic kidney disease compared to usual care.

Detailed Description
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Chronic kidney disease (CKD) is a major public health issue. Approximately, 11% of the US population has CKD with an increased prevalence among individuals great than 65years. Many individuals with CKD go unrecognized because they are typically asymptomatic. Individuals with CKD have been demonstrated to have a greater risk for mortality, hospitalization and development of end stage kidney disease. Also, individuals with CKD consume a significantly greater proportion of health care expenditures compared to other patients. This study aims to determine if the adoption of a chronic care model in conjunction with telemonitoring and case management can reduce risk of death, hospitalization, ER visits or admission to a skilled nursing facility in patients with CKD compared to usual care. This study will use a randomized controlled trial. Few interventions have been demonstrated to improve clinical outcomes in patients with CKD. If successful, this study will enable the VA to provide high quality care to patients with CKD while potentially reducing the cost of providing care.

Official Title
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Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Device: Video Telemonitoring Device with Clinical Care Modules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled at Minneapolis or St. Cloud Veterans Affairs Health Care System (VAHCS) or affiliated Community Based Outcomes Clinic(CBOC); Late eGFR within the VA system <60 ml/min/1.73m2 - Exclusion Criteria: Primary care provider unwilling to have participant included in study; unable to give consent; severe mental health condition; living in a nursing home -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br> | |
| Active Comparator: Intervention Device<br> | Device: Video Telemonitoring Device with Clinical Care Modules<br>* Telemonitoring of vital signs; videoconferencing, remote titration of diabetes, blood pressure, and lipid medications using evidence based treatment algorithm, and cooperative goal setting using education modules to enhance lifestyle changes<br>* Other names: Chronic Disease Management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of cost |  | one year | 
| incidence of end stage kidney disease |  | one year | 
| hospital re-admission |  | one year | 
| Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemonitoring, Chronic Kidney Disease