The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Telemonitoring in Coronary Artery Disease

Intervention / Treatment
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* Other: Telemonitoring


Participation Criteria
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Eligibility Criteria
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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

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multi-center randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring group<br>6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2). | Other: Telemonitoring<br> <br> |
| No Intervention: Usual care group<br>Usual care from t0 up until the common stopping date (t2). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality | Start of study to long-term follow-up (6.5 years). | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemonitoring, Chronic Heart Failure, eHealth, Mortality