Telemonitoring in Patients With Heart Failure

NCT ID: NCT00502255

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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telemonitoring

Health Buddy in patients home situation

Group Type EXPERIMENTAL

Health Buddy system

Intervention Type DEVICE

Patients are followed on distance by the Health Buddy system.

usual care

patients receive care as usual

Group Type EXPERIMENTAL

Telemonitoring in patients with heart failure

Intervention Type DEVICE

Health Buddy in patients home situation.

Interventions

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Health Buddy system

Patients are followed on distance by the Health Buddy system.

Intervention Type DEVICE

Telemonitoring in patients with heart failure

Health Buddy in patients home situation.

Intervention Type DEVICE

Other Intervention Names

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TEHAF study Therapy compliance in patients with heart failure Cost effectiveness TEHAf study

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Josiane Boyne

RN,MA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hubertus J Vrijhoef, Dr

Role: STUDY_CHAIR

University Maastricht

Locations

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Atrium Medische Centrum

Heerlen, Limburg, Netherlands

Site Status

Maastricht University Hospital

Maastricht, Limburg, Netherlands

Site Status

Orbis Medische en Zorgconcern

Sittard, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 22588319 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20615505 (View on PubMed)

Other Identifiers

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072036

Identifier Type: -

Identifier Source: org_study_id

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