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Sponsors and Collaborators: |
Charite University, Berlin, Germany German Federal Ministry of Economics and Technology |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00543881 |
Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to usual care in terms of:
Condition | Intervention | Phase |
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Chronic Heart Failure |
Device: Remote patient monitoring (Partnership for the Heart) Device: Usual care group |
Phase III |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Telemedical Interventional Monitoring in Heart Failure (TIM-HF) |
Enrollment: | 600 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Interventional group
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Device: Remote patient monitoring (Partnership for the Heart)
Guideline-based care in heart failure (NYHA II-III) including 5 scheduled doctor's visits plus daily monitoring of ECG, weight, blood pressure, self-report of health status, weekly monitoring of physical fitness
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2: Active Comparator
Usual care group
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Device: Usual care group
Guideline-based care in heart failure (NYHA II-III) including 5 scheduled doctor's visits
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The clinical trial assesses 600 patients over a period of 15 months (January 2008 until March 2009); all participants will continue to receive usual care from their GP. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 300 of the patients will be randomly allocated to receive devices for Remote Patient Monitoring which will measure various parameters on a daily basis (e.g., weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Charité - Universitaetsmedizin Berlin | |
Berlin, Germany, 10117 | |
Robert-Bosch-Krankenhaus | |
Stuttgart, Germany, 70376 |
Principal Investigator: | Friedrich Koehler, MD | Charité - Universitaetsmedizin Berlin |
Study ID Numbers: | 01MG532 |
Study First Received: | October 11, 2007 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00543881 |
Health Authority: | Germany: Ethics Commission |
telemedicine remote patient monitoring chronic heart failure mortality health economics |
Heart Failure Heart Diseases |
Cardiovascular Diseases |