Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Video Telemonitoring Device with Clinical Care Modules
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Telemonitoring, Chronic Kidney Disease
Eligibility Criteria
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
-
Sites / Locations
- VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual Care
Intervention Device
Arm Description
Outcomes
Primary Outcome Measures
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)
Secondary Outcome Measures
reduction of cost
incidence of end stage kidney disease
hospital re-admission
Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin
Full Information
NCT ID
NCT01446029
First Posted
September 28, 2011
Last Updated
August 1, 2014
Sponsor
Minneapolis Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01446029
Brief Title
Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)
Official Title
Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Telemonitoring, Chronic Kidney Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
601 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Title
Intervention Device
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Video Telemonitoring Device with Clinical Care Modules
Other Intervention Name(s)
Telehealth, Telemonitoring, Chronic Disease Management
Intervention Description
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
Primary Outcome Measure Information:
Title
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)
Time Frame
one year
Secondary Outcome Measure Information:
Title
reduction of cost
Time Frame
one year
Title
incidence of end stage kidney disease
Time Frame
one year
Title
hospital re-admission
Time Frame
one year
Title
Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areef Ishani, MD
Organizational Affiliation
US Department of Veterans Affairs
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21617090
Citation
Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Ayers D, Parfrey PS. A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jun;6(6):1241-7. doi: 10.2215/CJN.07160810. Epub 2011 May 26.
Results Reference
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PubMed Identifier
21636796
Citation
Ishani A, Greer N, Taylor BC, Kubes L, Cole P, Atwood M, Clothier B, Ercan-Fang N. Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1689-94. doi: 10.2337/dc10-2121. Epub 2011 Jun 2.
Results Reference
background
PubMed Identifier
21911628
Citation
Santschi V, Chiolero A, Burnand B, Colosimo AL, Paradis G. Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch Intern Med. 2011 Sep 12;171(16):1441-53. doi: 10.1001/archinternmed.2011.399.
Results Reference
background
Learn more about this trial
Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)
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