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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Areef Ishani, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01446029
First received: September 28, 2011
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Chronic Kidney Disease
 Device: Video Telemonitoring Device with Clinical Care Modules
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction of cost [ Time Frame: one year ] [ Designated as safety issue: No ]
  • incidence of end stage kidney disease [ Time Frame: one year ] [ Designated as safety issue: No ]
  • hospital re-admission [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Veterans Health Administration
  More Information

No publications provided

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
Study First Received: September 28, 2011
Last Updated: February 11, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 23, 2013