Remote Monitoring of Patients With CHF in Central Greece (RHCluster7GR)

Regional Health Authority of Sterea & Thessaly

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Procedure: Home telemonitoring of patients with CHF

Study type: Interventional

Funder types: Other

Identifiers

NCT01503463

FR2016

EC Grant Agreement 250487 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

Full description

The purpose of this study is to the evaluate the use of a mobile and PSTN phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. Following this; it is also hypothesized that this will also lead to a change in overall risk for CHF complications. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 65 years.
• Discharge from hospital after acute heart failure in the previous 3 months and FE < 40% or FE > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization

Exclusion criteria

• Comorbidities prevalent on CHF with life expectation < 12 months.
• Inability to use the equipment and help at home not available.
• Myocardial infarction or percutaneous coronary intervention in the last 3 months.
• Coronary artery bypass, valve substitution or correction in the last 6 months or scheduled.
• Being on waiting list for heart transplantation.
• Being enrolled in other trial.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients in the control group receive usual care delivered by their primary care physicians and cardiologists. Usual care consists of regular visits to the specialist or primary care clinics every time a medication change is required, or a medical examination is needed.

Home telemonitoring of patients with CHF

Experimental group

Treatment:

Procedure: Home telemonitoring of patients with CHF