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Telemedical Interventional Management in Heart Failure II (TIM-HF II)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01878630
First Posted: June 17, 2013
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German Federal Ministry of Education and Research
University of Leipzig
Information provided by (Responsible Party):
Friedrich Koehler, Charite University, Berlin, Germany
June 12, 2013
June 17, 2013
May 16, 2017
August 2013
May 2017   (Final data collection date for primary outcome measure)
Days lost due to unplanned cardiovascular hospitalization or death. [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01878630 on ClinicalTrials.gov Archive Site
  • all-cause mortality (time-to-event) [ Time Frame: 12 months ]
  • cardiovascular mortality (time-to-event) [ Time Frame: 12 months ]
  • days lost regarding 12month follow-up due to unplanned cardiovascular hospitalizations [ Time Frame: 12 months ]
  • days lost regarding 12month follow-up due to HF-hospitalization; number of unplanned cardiovascular hospitalizations (adjusted to death) [ Time Frame: 12 months ]
  • number of unplanned HF-hospitalizations (adjusted to death) [ Time Frame: 12 months ]
  • number of unplanned cardiovascular re-admissions within 30 days after discharge from unplanned cardiovascular hospitalization [ Time Frame: 12 months ]
  • quality of life, depression and self-care behaviour [ Time Frame: 12 months ]
    Quality of life measured by Minnesota Living with Heart Failure Questionnaire; EQ-5D-3L, depression by PHQ-9 and self-care behaviour by EHFScBS-9
  • cost-utility analysis (QALY-analysis) [ Time Frame: 12 months ]
  • all-cause mortality (time-to-event) [ Time Frame: 12 months ]
  • cardiovascular mortality (time-to-event) [ Time Frame: 12 months ]
  • days lost regarding 12month follow-up due to unplanned cardiovascular hospitalizations [ Time Frame: 12 months ]
  • days lost regarding 12month follow-up due to HF-hospitalization; number of unplanned cardiovascular hospitalizations (adjusted to death) [ Time Frame: 12 months ]
  • number of unplanned HF-hospitalizations (adjusted to death) [ Time Frame: 12 months ]
  • number of unplanned cardiovascular re-admissions within 30 days after discharge from unplanned cardiovascular hospitalization [ Time Frame: 12 months ]
  • quality of life, depression and self-care behaviour [ Time Frame: 12 months ]
    Quality of life measured by Minnesota Living with Hear Failure Questionnaire; EQ-5D-3L, depression by PHQ-9 and self-care behaviour by EHFScBS-9
  • cost-utility analysis (QALY-analysis) [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Telemedical Interventional Management in Heart Failure II
Not Provided

Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:

  • days lost due to unplanned cardiovascular hospitalization or death
  • all-cause mortality
  • cardiovascular mortality
  • quality of life
The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Heart Failure
  • Device: Remote Patient Management

    Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist) plus devices for Remote Patient Management at patient site for daily monitoring of ECG, weight, blood pressure, self-report of health status:

    • weighing scale (Seca 861 with bluetooth, seca gmbh & co. kg.)
    • blood pressure device (UA767PBT with bluetooth, A&D Ltd.)
    • ECG-eventrecorder (PhysioMem® PM 1000, getemed Medizin- und Informationstechnik AG)
    • patient-communication platform (Physio-Gate® PG 1000, getemed Medizin- und Informationstechnik AG)
    • help call device (DORO Easy 510/ Doro HandlePlus 334gsm, doro AB)

    at center site:

    - electronic patient record (eHealth connect 2.0, T-Systems International)

    Other Name: R&D project "Fontane"
  • Other: Usual Care
    Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)
  • Experimental: Remote Patient Management
    intervention group
    Intervention: Device: Remote Patient Management
  • Active Comparator: Usual Care
    control group
    Intervention: Other: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1535
May 2018
May 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • chronic heart failure New York Heart Association (NYHA) class II or III
  • echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or >45% + minimum 1 diuretic in permanent medicinal therapy
  • hospitalization due to decompensated HF within the last 12months before randomization
  • informed consent

Exclusion Criteria:

  • hospitalization within the last 7 days before randomization
  • implanted cardiac assist system
  • acute coronary syndrome within the last 7 days before randomization
  • high urgent listed for heart transplantation (HTx)
  • planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
  • revascularization and/or CRT-implantation within 28 days before randomization
  • known alcohol or drug abuse
  • terminal renal insufficiency with hemodialysis
  • impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
  • existence of any disease reducing life expectancy to less than 1 year
  • age <18 years
  • pregnancy
  • participation in other treatment studies or remote patient management programmes (register studies possible)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01878630
13KQ0904B
Yes
Not Provided
Not Provided
Friedrich Koehler, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • German Federal Ministry of Education and Research
  • University of Leipzig
Principal Investigator: Friedrich Koehler, Prof. Dr. Charité - Universitaetsmedizin Berlin
Charite University, Berlin, Germany
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP