Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)
1 other identifier
interventional
601
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
October 4, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedAugust 4, 2014
August 1, 2014
1.6 years
September 28, 2011
August 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)
one year
Secondary Outcomes (4)
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
Study Arms (2)
Usual Care
NO INTERVENTIONIntervention Device
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center
Minneapolis, Minnesota, 55417, United States
Related Publications (3)
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.
PMID: 21617090BACKGROUNDIshani 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.
PMID: 21636796BACKGROUNDSantschi 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.
PMID: 21911628BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Areef Ishani, MD
US Department of Veterans Affairs
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Section of Nephrology; Associate Professor of Medicine
Study Record Dates
First Submitted
September 28, 2011
First Posted
October 4, 2011
Study Start
March 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
August 4, 2014
Record last verified: 2014-08