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

Chronic Kidney Disease Clinical Trial

Official title:

Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446029
• Other study ID #: Minn-VAMC-4292-A
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2011
• Last updated: August 1, 2014
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	VA Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Ayers D, Parfrey PS. A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jun;6(6):1241-7. doi: 10.2215/CJN.07160810. Epub 2011 May 26. — View Citation

Ishani A, Greer N, Taylor BC, 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: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1689-94. doi: 10.2337/dc10-2121. Epub 2011 Jun 2. — View Citation

Santschi V, Chiolero A, Burnand B, Colosimo AL, Paradis G. Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch Intern Med. 2011 Sep 12;171(16):1441-53. doi: 10.1001/archinternmed.2011.399. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)		one year	No
Secondary	reduction of cost		one year	No
Secondary	incidence of end stage kidney disease		one year	No
Secondary	hospital re-admission		one year	No
Secondary	Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin		one year	No