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Completed

NCT Number: NCT01446029

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA Medical Center

Minneapolis, Minnesota, 55417, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Video Telemonitoring Device with Clinical Care Modules

Device

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 outcomes

  1. composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)

    Time frame: one year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Registry information

Official study title

Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2011
Registry last updated
Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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