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

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ClinicalTrials.gov Identifier: NCT01446029
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Areef Ishani, Minneapolis Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Device: Video Telemonitoring Device with Clinical Care Modules Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Usual Care
Active Comparator: Intervention Device Device: Video Telemonitoring Device with Clinical Care Modules
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
Other Names:
  • Telehealth
  • Telemonitoring
  • Chronic Disease Management



Primary Outcome Measures :
  1. composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. reduction of cost [ Time Frame: one year ]
  2. incidence of end stage kidney disease [ Time Frame: one year ]
  3. hospital re-admission [ Time Frame: one year ]
  4. Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446029


Locations
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Areef Ishani, MD VA Office of Research and Development

Publications:
Responsible Party: Areef Ishani, Chief, Section of Nephrology; Associate Professor of Medicine, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01446029     History of Changes
Other Study ID Numbers: Minn-VAMC-4292-A
First Posted: October 4, 2011    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014

Keywords provided by Areef Ishani, Minneapolis Veterans Affairs Medical Center:
Telemonitoring
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency