Chronic Heart Failure
Conditions
Keywords
Home Telemonitoring
Brief summary
The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the combined clinical endpoint days alive and not in hospital nor stationary care per days in study and the change in total cost compared to that of the control group.
Detailed description
Between January 2010 and June 2013, 621 patients with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled and randomly assigned to two study arms comprising usual care and a home telemonitoring group. The 302 patients enrolled in the intervention group are supported by an interactive bi-directional home telemonitoring system (Motiva®) that collects and transfers patient's vital sign data to a dedicated telemedicine data centre. All patients were to remain in the study for one year with an examination at the beginning and both, after 6 and 12 months.
Interventions
DEVICERemote patient monitoring (Motiva)
interactive bi-directional home telemonitoring system that provides remote monitoring
Sponsors
German Federal Ministry of Education and Research
Eckhard Nagel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of Chronic Heart Failure (CHF) based on European Society of Cardiology (ESC) guidelines * Symptoms corresponding to New York Heart Association (NYHA) functional class II-IV * Left Ventricular Ejection Fraction (LVEF) ≤ 40% * American Heart Association (AHA) classification stage C or D * Age \> 18 years * Discharged after hospitalisation for worsening Chronic Heart Failure (CHF) within the last twelve months * Able to understand the German language * Sufficient eyesight to understand and follow the instructions communicated by the Motiva® platform * Willing and able to use the required hard- and software and maintain a patient diary * Residing within geographical reach of one of the ten study sites in order to receive additional treatment if required as well as follow-up consultation * Willingness to provide informed consent regarding benefits and risks related to the trial, and to sign a participation agreement for the installation of the telemedicine platform Motiva®
Exclusion criteria
* Myocardial infarction within the past four weeks * Heart surgery or any coronary intervention within the past eight weeks * Cardiogenic shock within the past four weeks * Intended cardiac surgery within the next six months or priority status on a waiting list for organ transplantation * Severe chronic and pulmonary illness with an immediate impact on the main outcome measures * Renal failure requiring dialysis * Dementia or other severe cognitive impairment * Psychiatric disorders rendering patients unable to participate in the trial * Discharged to or living in a geriatric clinic or a nursing home * Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incremental cost effectiveness ratio (ICER) | 1 year | consisting of the combined clinical endpoint days alive and not in hospital nor stationary care per days in study and the change in total cost |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes - total mortality | 1 year | total mortality |
| Clinical Outcome - number of inpatient treatment | 1 year | number of inpatient treatment |
| Clinical Outcome - length of stay in hospital or nursing home | 1 year | length of stay in hospital or nursing home |
| Clinical Outcome - functional state of health | 1 year | functional state of health |
| Clinical Outcome - health related quality of life | 1 year | health related quality of life |
Countries
Germany
Outcome results
None listed