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

Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01446029
Enrollment
601
Registered
2011-10-04
Start date
2012-03-31
Completion date
2013-10-31
Last updated
2014-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Telemonitoring, Chronic Kidney Disease

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.

Interventions

DEVICEVideo 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

Sponsors

Minneapolis Veterans Affairs Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frame
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)one year

Secondary

MeasureTime frame
reduction of costone year
incidence of end stage kidney diseaseone year
hospital re-admissionone year
Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobinone year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026