NCT00502255

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

6.2 years

First QC Date

July 16, 2007

Last Update Submit

April 7, 2015

Conditions

Heart Failure, Congestive

Keywords

TelemonitoringCost-effectivenessHeart failureCase management

Outcome Measures

Primary Outcomes (3)

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

    one year

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

    one year

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

    one year

Secondary Outcomes (2)

  • 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?

    one year

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

    one year

Study Arms (2)

telemonitoring

EXPERIMENTAL

Health Buddy in patients home situation

Device: Health Buddy system

usual care

EXPERIMENTAL

patients receive care as usual

Device: Telemonitoring in patients with heart failure

Interventions

Health Buddy systemDEVICE

Patients are followed on distance by the Health Buddy system.

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

Health Buddy in patients home situation.

Also known as: TEHAf study
usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Atrium Medische Centrum

Heerlen, Limburg, Netherlands

Location

Maastricht University Hospital

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Orbis Medische en Zorgconcern

Sittard, Limburg, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 22588319DERIVED

  • 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.

    PMID: 20615505DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Hubertus J Vrijhoef, Dr

    University Maastricht

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN,MA

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

NL(3)