Clinical trial NCT03171038: The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemonitoring in Coronary Artery Disease
Keywords: Telemonitoring
Chronic Heart Failure
eHealth
Mortality
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: All-cause mortality
timeFrame: Start of study to long-term follow-up (6.5 years).
Secondary outcomes:
measure: days lost due to heart failure readmissions
timeFrame: Start of study to long-term follow-up (6.5 years).
measure: days lost due to all readmissions
timeFrame: Start of study to long-term follow-up (6.5 years).
measure: days lost due to death or heart failure readmissions
timeFrame: Start of study to long-term follow-up (6.5 years).
measure: percentage of follow-up time spent in hospital for heart failure
timeFrame: Start of study to long-term follow-up (6.5 years).
measure: percentage of follow-up time spent in hospital for all reasons
timeFrame: Start of study to long-term follow-up (6.5 years).
measure: percentage of follow-up time lost to death or heart failure readmissions
timeFrame: Start of study to long-term follow-up (6.5 years).
Other outcomes:
Locations:
Study officials:
References:
citation: Frederix I, Vanderlinden L, Verboven AS, Welten M, Wouters D, De Keulenaer G, Ector B, Elegeert I, Troisfontaines P, Weytjens C, Mullens W, Dendale P. Long-term impact of a six-month telemedical care programme on mortality, heart failure readmissions and healthcare costs in patients with chronic heart failure. J Telemed Telecare. 2019 Jun;25(5):286-293. doi: 10.1177/1357633X18774632. Epub 2018 May 10.