Effectiveness of a Website and Telemonitoring in Patients With Heart Failure.

NCT ID: NCT01755988

Last Updated: 2017-01-05

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

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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The number of people with heart failure is increasing in the western world. Mainly due to better treatment of myocardial infarctions and ageing of the population. The amount of health care workers is unfortunately not increasing. We want to investigate how two electronic devices (a website and an interactive web-based platform) influence the self-care, quality of life, hospitalizations and mortality by delivering care from a distance. We also want to investigate if a higher quality of care is delivered despite of less frequent visits to a nurse and/or doctor. The study takes place in the Netherlands and is a randomized trial. Patients with heart failure, registered by an outpatient heart failure clinic or general practitioner can take part. They will be randomized to 3 groups: group 1 receives standard care, group 2 receives standard care with the website, group 3 receives an adjusted care pathway, with both the website and the interactive web-based platform connected to a telemonitoring system. In this group all routine consultations with heart failure nurses and general practitioner will be substituted by this device.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Educational website.

Educational website (in addition to usual care).

Group Type EXPERIMENTAL

Educational website (in addition to usual care).

Intervention Type OTHER

Website and interactive platform with telemonitoring.

Adjusted care pathway, including both the educational website and an interactive web-based platform with telemonitoring facilities. In this arm all routine consultations with heart failure nurses and general practitioner will be substituted by this combination of telemonitoring facilities connected to an interactive web-based platform plus the Dutch version of the European Society of Cardiology (ESC) website on heart failure.

Group Type EXPERIMENTAL

Website and interactive platform with telemonitoring.

Intervention Type OTHER

Interventions

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Educational website (in addition to usual care).

Intervention Type OTHER

Website and interactive platform with telemonitoring.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* heart failure established according to the guidelines of the European Society of Cardiology, and confirmed with echocardiography at least three months earlier. The three month period is used to allow for enough time for essential education and initiation of treatment.
* Sufficient cognitive and physical function to understand the aim of the study and perform or undergo the required measurements and sign informed consent.
* Aged 18 years or over.

Exclusion Criteria

* Non-availability of internet and e-mail.
* Inability to work with internet and e-mail.
* Inability of the patient and his/her family or care takers to read and understand Dutch.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation: Zorg Binnen Bereik

UNKNOWN

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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F.H. Rutten

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arno W Hoes, Dr. MD

Role: STUDY_DIRECTOR

University Medical Center Utrecht (UMC Utrecht)

Frans H Rutten, Dr. MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht (UMC Utrecht)

Locations

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Amstelland hospital

Amstelveen, , Netherlands

Site Status

Rijnstate hospital

Arnhem, , Netherlands

Site Status

Gelderse Vallei Hospital

Ede, , Netherlands

Site Status

Diakonessenhuis hospital

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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Brons M, Ten Klooster I, van Gemert-Pijnen L, Jaarsma T, Asselbergs FW, Oerlemans MIFJ, Koudstaal S, Rutten FH. Patterns in the Use of Heart Failure Telemonitoring: Post Hoc Analysis of the e-Vita Heart Failure Trial. JMIR Cardio. 2023 Jan 31;7:e41248. doi: 10.2196/41248.

Reference Type DERIVED
PMID: 36719715 (View on PubMed)

Wagenaar KP, Broekhuizen BDL, Jaarsma T, Kok I, Mosterd A, Willems FF, Linssen GCM, Agema WRP, Anneveldt S, Lucas CMHB, Mannaerts HFJ, Wajon EMCJ, Dickstein K, Cramer MJ, Landman MAJ, Hoes AW, Rutten FH. Effectiveness of the European Society of Cardiology/Heart Failure Association website 'heartfailurematters.org' and an e-health adjusted care pathway in patients with stable heart failure: results of the 'e-Vita HF' randomized controlled trial. Eur J Heart Fail. 2019 Feb;21(2):238-246. doi: 10.1002/ejhf.1354. Epub 2018 Nov 28.

Reference Type DERIVED
PMID: 30485612 (View on PubMed)

Wagenaar KP, Broekhuizen BD, Dickstein K, Jaarsma T, Hoes AW, Rutten FH. Effectiveness of an interactive platform, and the ESC/HFA heartfailurematters.org website in patients with heart failure: design of the multicentre randomized e-Vita heart failure trial. Eur J Heart Fail. 2015 Dec;17(12):1310-6. doi: 10.1002/ejhf.413. Epub 2015 Oct 1.

Reference Type DERIVED
PMID: 26424105 (View on PubMed)

Other Identifiers

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12-456

Identifier Type: -

Identifier Source: org_study_id

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