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CompletedNCT03171038TEMA-HFLTUpdated Jun 1, 2017

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

An interventional study of Telemonitoring in Telemonitoring in Coronary Artery Disease, sponsored by Hasselt University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-01.

Sponsored by Hasselt University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 years 1 month after the study started (first participant enrolled Apr 2008, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Telemonitoring in Coronary Artery Disease

Keywords

  • Telemonitoring
  • Chronic Heart Failure
  • eHealth
  • Mortality
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 160 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Telemonitoring group

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

    Other: Telemonitoring

  • No intervention
    Usual care group

    Usual care from t0 up until the common stopping date (t2).

Interventions

  • OtherTelemonitoring
06

What researchers measure

Primary outcomes

  1. All-cause mortality

    All-cause mortality

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

Secondary outcomes

  1. days lost due to heart failure readmissions

    days lost due to heart failure readmissions

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

  2. days lost due to all readmissions

    days lost due to all readmissions

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

  3. days lost due to death or heart failure readmissions

    days lost due to death or heart failure readmissions

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

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

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

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

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

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

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

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

    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).

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29742959 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03171038
Lead sponsor
Hasselt University
Responsible party
prof. dr. Paul Dendale (Prof. dr., Hasselt University) — Principal investigator
First posted
May 31, 2017
Start date
Apr 1, 2008
Primary completion
Aug 1, 2015
Completion
Aug 1, 2015
Last update
Jun 1, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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