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Completed

NCT Number: NCT03171038

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

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.

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Key information

Conditions

Telemonitoring in Coronary Artery Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring

Other

Primary outcomes

  1. All-cause mortality

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

    All-cause mortality

Secondary outcomes

  1. days lost due to heart failure readmissions

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

    days lost due to heart failure readmissions

  2. days lost due to all readmissions

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

    days lost due to all readmissions

  3. days lost due to death or heart failure readmissions

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

    days lost due to death or heart failure readmissions

  4. percentage of follow-up time spent in hospital for heart failure

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

    percentage of follow-up time spent in hospital for heart failure

  5. percentage of follow-up time spent in hospital for all reasons

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

    percentage of follow-up time spent in hospital for all reasons

  6. percentage of follow-up time lost to death or heart failure readmissions

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

    percentage of follow-up time lost to death or heart failure readmissions

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study 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

Acronym: TEMA-HFLT

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
May 31, 2017
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.