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| Sponsors and Collaborators: |
Charite University, Berlin, Germany German Federal Ministry of Economics and Technology |
|---|---|
| Information provided by: | Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00543881 |
Purpose
Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to usual care in terms of:
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
Interventional group
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Charité - Universitaetsmedizin Berlin | |
| Berlin, Germany, 10117 | |
| Robert-Bosch-Krankenhaus | |
| Stuttgart, Germany, 70376 | |
| Principal Investigator: | Friedrich Koehler, MD | Charité - Universitaetsmedizin Berlin |
More Information
| 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 |
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Heart Failure Heart Diseases |
|
Cardiovascular Diseases |
