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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03171038
Acronym
TEMA-HFLT
Enrollment
160
Registered
2017-05-31
Start date
2008-04-01
Completion date
2015-08-01
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Telemonitoring in Coronary Artery Disease

Keywords

Telemonitoring, Chronic Heart Failure, eHealth, Mortality

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.

Interventions

OTHERTelemonitoring

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Prospective, multi-center randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortalityStart of study to long-term follow-up (6.5 years).All-cause mortality

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026