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CompletedNCT00502255TEHAF2Updated Apr 8, 2015

Telemonitoring in Patients With Heart Failure

An interventional study of Health Buddy system and Telemonitoring in patients with heart failure in Heart Failure, Congestive, sponsored by Maastricht University Medical Center. Completed at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-08.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
382
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.

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Conditions studied

  • Heart Failure, Congestive

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Keywords

  • Telemonitoring
  • Cost-effectiveness
  • Heart failure
  • Case management
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 382 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 121 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

  • Patients > 18 years
  • Patients with heart failure NYHA classification II-III-IV
  • Patient experienced a period of fluid retention
  • Patient is treated by a cardiologist
  • Patient is followed-up by a heart failure nurse
  • Adequate knowledge of the Dutch language
  • Patient has an active telephone connection, preferably analogue
  • Patient is mental competent
  • Patient has the disposal of a balance

Exclusion criteria

Exclusion Criteria:

  • Patients suffering from COPD, Gold classification 3 or 4
  • Patient is a dialysis patient
  • Patient has a visual restriction to read the dialogues on the Health Buddy
  • Patient is hard of hearing or deaf
  • Patient suffers from a lethal sickness with a prognosis \< 1 year
  • Patient participates in another trial
  • Patient needs a hospital admission on short time, i.e., \< 3 months
  • Patient used the Health Buddy in an earlier stage
  • Patient is an illiterate person.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
382 participants (actual)

Study arms

  • Experimental
    telemonitoring

    Health Buddy in patients home situation

    Device: Health Buddy system

  • Experimental
    usual care

    patients receive care as usual

    Device: Telemonitoring in patients with heart failure

Interventions

  • DeviceHealth Buddy system

    Patients are followed on distance by the Health Buddy system.

    Also known as: TEHAF study, Therapy compliance in patients with heart failure, Cost effectiveness

  • DeviceTelemonitoring in patients with heart failure

    Health Buddy in patients home situation.

    Also known as: TEHAf study

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What researchers measure

Primary outcomes

  1. To what extent does the use of Health Buddy result in a decrease in hospital admissions?

    Time frame: one year

  2. To what extent is Health Buddy® more cost-effective than usual care?

    Time frame: one year

  3. To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?

    Time frame: one year

Secondary outcomes

  1. What is the effect of Health Buddy® in patients with heart failure in regard to drug consumption and therapy compliance and level of knowledge, and quality of life?

    Time frame: one year

  2. To what extent is it - based on patients' characteristics - possible to identify patient with benefits?

    Time frame: one year

07

Study locations

3 sites
  • Atrium Medische Centrum
    Heerlen, Limburg, Netherlands
  • Maastricht University Hospital
    Maastricht, Limburg 6202 AZ, Netherlands
  • Orbis Medische en Zorgconcern
    Sittard, Limburg, Netherlands
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References and documents

Publications

  • Boyne JJ, Vrijhoef HJ, Crijns HJ, De Weerd G, Kragten J, Gorgels AP; TEHAF investigators. Tailored telemonitoring in patients with heart failure: results of a multicentre randomized controlled trial. Eur J Heart Fail. 2012 Jul;14(7):791-801. doi: 10.1093/eurjhf/hfs058. Epub 2012 May 15. PubMed 22588319 ↗
  • Boyne JJ, Vrijhoef HJ, Wit Rd, Gorgels AP. Telemonitoring in patients with heart failure, the TEHAF study: Study protocol of an ongoing prospective randomised trial. Int J Nurs Stud. 2011 Jan;48(1):94-9. doi: 10.1016/j.ijnurstu.2010.05.017. Epub 2010 Jul 7. PubMed 20615505 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00502255
Lead sponsor
Maastricht University Medical Center
Collaborators
Maastricht University
Responsible party
Josiane Boyne (RN,MA, Maastricht University Medical Center) — Principal investigator
First posted
Jul 17, 2007
Start date
Oct 2007
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Apr 8, 2015

Study contacts

Hubertus J Vrijhoef, Dr
study chair · University Maastricht

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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