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

Not Applicable

Completed

• Conditions: Telemonitoring in Coronary Artery Disease
• Interventions: Other: Telemonitoring

• Registration Number: NCT03171038
• Lead Sponsor: Hasselt University

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.

Study Timeline

• Study Start: 2008-04-01
• Primary Completion: 2015-08-01
• Study Completion: 2015-08-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring group	Telemonitoring	6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2).

Primary Outcome Measures

Name	Time	Method
All-cause mortality	Start of study to long-term follow-up (6.5 years).	All-cause mortality

Secondary Outcome Measures

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