Overview

This trial has been completed.

Condition chronic heart failure
Treatment remote patient monitoring (motiva)
Sponsor Eckhard Nagel
Collaborator German Federal Ministry of Education and Research
Start date March 2009
End date March 2016
Trial size 621 participants
Trial identifier NCT02293252, 01KX0805

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
Remote patient monitoring system (Motiva)
remote patient monitoring (motiva)
interactive bi-directional home telemonitoring system that provides remote monitoring
(No Intervention)
Best medical treatment according to the guidelines of the European Society of Cardiology (ESC)

Primary Outcomes

Measure
incremental cost effectiveness ratio (ICER)
time frame: 1 year

Secondary Outcomes

Measure
Clinical Outcomes - total mortality
time frame: 1 year
Clinical Outcome - number of inpatient treatment
time frame: 1 year
Clinical Outcome - length of stay in hospital or nursing home
time frame: 1 year
Clinical Outcome - functional state of health
time frame: 1 year
Clinical Outcome - health related quality of life
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Gesundheitsökonomische Methodenentwicklung am Beispiel Der Evaluation Einer Technologiebasierten, sektorübergreifenden Intervention Zur Versorgung Chronisch Kranker Patienten
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Bayreuth.