CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Device: Remote patient monitoring (Motiva)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Remote patient monitoring system (Motiva) | Device: Remote patient monitoring (Motiva)<br>* interactive bi-directional home telemonitoring system that provides remote monitoring<br>|
| No Intervention: Control group<br>Best medical treatment according to the guidelines of the European Society of Cardiology (ESC) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incremental cost effectiveness ratio (ICER) | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes - total mortality | total mortality | 1 year | 
| Clinical Outcome - number of inpatient treatment | number of inpatient treatment | 1 year | 
| Clinical Outcome - length of stay in hospital or nursing home | length of stay in hospital or nursing home | 1 year | 
| Clinical Outcome - functional state of health | functional state of health | 1 year | 
| Clinical Outcome - health related quality of life | health related quality of life | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Telemonitoring