Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Areef Ishani, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01446029
First received: September 28, 2011
Last updated: August 1, 2014
Last verified: August 2014

September 28, 2011
August 1, 2014
March 2012
October 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01446029 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)
Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Chronic Kidney Disease
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
  • No Intervention: Usual Care
  • Active Comparator: Intervention Device
    Intervention: Device: Video Telemonitoring Device with Clinical Care Modules
Ishani A, Greer N, Taylor B, 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. Diabetes Care 34:1689-1694, 2011

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
601
October 2013
October 2013   (final data collection date for primary outcome measure)

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

-

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01446029
Minn-VAMC-4292-A
Yes
Areef Ishani, Minneapolis Veterans Affairs Medical Center
Minneapolis Veterans Affairs Medical Center
Not Provided
Principal Investigator: Areef Ishani, MD Veterans Health Administration
Minneapolis Veterans Affairs Medical Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP