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OpenTrials
Completed

NCT Number: NCT00502255

Telemonitoring in Patients With Heart Failure

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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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Medische Centrum, Heerlen, Limburg, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

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

  • 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.

Treatment and study plan

Health Buddy system

Device

Patients are followed on distance by the Health Buddy system.

Other names: TEHAF study, Therapy compliance in patients with heart failure, Cost effectiveness

Telemonitoring in patients with heart failure

Device

Health Buddy in patients home situation.

Other names: TEHAf study

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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Maastricht University

Registry information

Acronym: TEHAF2

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2007
Registry last updated
Apr 8, 2015

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.

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