Telemonitoring in Patients With Heart Failure (TEHAF2)

April 7, 2015 updated by: Josiane Boyne, Maastricht University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands
        • Atrium Medische Centrum
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Maastricht University Hospital
      • Sittard, Limburg, Netherlands
        • Orbis Medische en Zorgconcern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: telemonitoring
Health Buddy in patients home situation
Device: Health Buddy system
Patients are followed on distance by the Health Buddy system.
Other Names:
  • TEHAF study
  • Therapy compliance in patients with heart failure
  • Cost effectiveness
Experimental: usual care
patients receive care as usual
Device: Telemonitoring in patients with heart failure
Health Buddy in patients home situation.
Other Names:
  • TEHAf study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To what extent does the use of Health Buddy result in a decrease in hospital admissions?
Time Frame: one year
one year
To what extent is Health Buddy® more cost-effective than usual care?
Time Frame: one year
one year
To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year
To what extent is it - based on patients' characteristics - possible to identify patient with benefits?
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Maastricht University

Investigators

  • Study Chair: Hubertus J Vrijhoef, Dr, University Maastricht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 072036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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