Remote Monitoring of Patients With CHF in Central Greece

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Procedure: Home telemonitoring of patients with CHF

• Registration Number: NCT01503463
• Lead Sponsor: Regional Health Authority of Sterea & Thessaly

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-04
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home telemonitoring of patients with CHF	Home telemonitoring of patients with CHF	-

Primary Outcome Measures

Name	Time	Method
Number of hospitalisations for heart failure	12 months minimum
Combined end point of all cause mortality	12 months minimum

Secondary Outcome Measures

Name	Time	Method
Health related quality of life as measured by the SF-36 v2	12 months minimum- at the entry point of the intervention and the end
Cardiovascular and all-cause mortality	12 months minimum
Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ)	12 months minimum- at the entry point of the intervention and the end.
Disease Specific Quality of Life using the Minnesota Living with Heart Failure questionnaire (MLHF)	12 months minimum- at the entry point of the intervention and the end.
Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)	12 months minimum
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire	at 2nd and at 12th month

Trial Locations

Locations (1)

Cardiology Department - Regional University Hospital of Larisa; 🇬🇷 Larissa, Thessaly, Greece