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Sponsors and Collaborators: |
Yale University National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00303212 |
The primary purpose of this study is to determine the effectiveness of telemonitoring compared with usual guideline-based care in preventing hospitalization for heart failure patients.
Condition | Intervention |
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Congestive Heart Failure |
Other: Telemonitoring |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Study of Telemonitoring to Improve Heart Failure Outcomes |
Estimated Enrollment: | 1640 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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UC: No Intervention
Usual HF guideline-base care
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TM: Experimental
Telemonitoring group plus usual guideline-based HF care
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Other: Telemonitoring
Participants in the intervention group are instructed to make a daily toll-free call to an automated telemonitoring system being provided by Pharos Innovations® (Chicago, IL) for 6 months.On each call patients hear a pre-recorded voice that goes through a series of questions about symptoms and the patient's daily weight. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians at each practice site.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Harlan M. Krumholz, M.D. | Yale University |
Study Director: | Sarwat I Chaudhry, MD | Yale University |
Study Director: | Jennifer Mattera, MPH | Yale University |
Responsible Party: | Yale School of Medicine ( Harlan Krumholz. MD ) |
Study ID Numbers: | RO1-HL-080228, 27466 |
Study First Received: | March 13, 2006 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00303212 History of Changes |
Health Authority: | United States: Institutional Review Board |
heart failure CHF telemedicine disease management |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |