Long-term Impact of a 6-months Telemedical Care Program on Mortality, Readmissions and Healthcare Costs in Patients With Chronic Heart Failure The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study

Hasselt University0 sites160 target enrollmentApril 1, 2008

ConditionsTelemonitoring in Coronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Telemonitoring in Coronary Artery Disease
Sponsor: Hasselt University
Enrollment: 160
Primary Endpoint: All-cause mortality
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients.

Detailed Description

The telemonitoring (TM) group patients received a 6-months TM program, followed by standard heart failure care until the long-term follow-up evaluation. The usual care (UC) patients received ususal care during the first six months, followed by standard heart failure care until the long-term follow-up evaluation.

Registry

clinicaltrials.gov

Start Date

April 1, 2008

End Date

August 1, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hasselt University

Responsible Party

Principal Investigator

prof. dr. Paul Dendale

Prof. dr.

Hasselt University

Eligibility Criteria

Inclusion Criteria

•Chronic heart failure patients
•Treated for heart failure according to current guidelines
•≥ 18 years of age
•Able to provide informed consent

Exclusion Criteria

•Reversible forms of acute heart failure (myocarditis)
•Presence of severe aortic stenosis
•Previous residency in a nursing home
•Inclusion in a cardiac rehabilitation program on discharge
•Chronic kidney disease stage ≥ 4
•Planned dialysis in the next six months
•Life expectancy \< 1 year due to non-heart failure related reasons
•Severe chronic obstructive pulmonary disease, GOLD ≥ III
•Cognitive and/or mental problems interfering with the performance of daily measurements and data transmission

Outcomes

Primary Outcomes

All-cause mortality

Time Frame: Start of study to long-term follow-up (6.5 years).

All-cause mortality

Secondary Outcomes

days lost due to heart failure readmissions(Start of study to long-term follow-up (6.5 years).)
days lost due to all readmissions(Start of study to long-term follow-up (6.5 years).)
percentage of follow-up time spent in hospital for heart failure(Start of study to long-term follow-up (6.5 years).)
percentage of follow-up time spent in hospital for all reasons(Start of study to long-term follow-up (6.5 years).)
percentage of follow-up time lost to death or heart failure readmissions(Start of study to long-term follow-up (6.5 years).)
days lost due to death or heart failure readmissions(Start of study to long-term follow-up (6.5 years).)