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

M

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status and phase

Completed
Phase 3

Conditions

Chronic Kidney Disease

Treatments

Device: Video Telemonitoring Device with Clinical Care Modules

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01446029
Minn-VAMC-4292-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

601 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

601 participants in 2 patient groups

Usual Care
No Intervention group
Intervention Device
Active Comparator group
Treatment:
Device: Video Telemonitoring Device with Clinical Care Modules

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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