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AzTrials

Heart FailureNCT01755988

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

A study testing Website and interactive platform with telemonitoring. in people with Heart Failure, run by UMC Utrecht at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Website and interactive platform with telemonitoring.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
4 sitesNetherlands
Study dates
Sep 2013to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Amstelland hospital

    Amstelveen

  • Rijnstate hospital

    Arnhem

  • Gelderse Vallei Hospital

    Ede

  • Diakonessenhuis hospital

    Utrecht

Other trials in Netherlands

About this study

Official title: Effectiveness of an Interactive Web-based Platform and a Disease Specific Information Website in Patients With Heart Failure: a 3-arm Randomised Trial.

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.

Conditions
Heart Failure
Being tested
Educational website (in addition to usual care)., Website and interactive platform with telemonitoring.
Keywords
Telemedicine, Heart Failure, Self care, Quality of life, Mortality, Hospitalization
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational website (in addition to usual care).Other

  • Website and interactive platform with telemonitoring.Other

Study groups in NCT01755988
Study groupRoleWhat they receive
Usual careNo interventionNot described
Educational website.ExperimentalEducational website (in addition to usual care).
Receives: Other: Educational website (in addition to usual care).
Website and interactive platform with telemonitoring.ExperimentalAdjusted 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.
Receives: Other: Website and interactive platform with telemonitoring.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in self-care behaviour measured with the validated European Heart Failure Self Care Behaviour Scale(EHFScB scale)

    The EHFScB measures the behaviour heart failure patients undertake to maintain life, healthy functioning, and well-being. This includes behaviours like adherence to medication, diet and exercise, as well as self-management of symptoms, but it also refers to behaviours such as daily weighing to assess fluid retention and seeking assistance when symptoms occur. The EHFScB is a nine items presented on a 5 point scale.

    Measured: at 3, 6 and 12 months

  2. Change in health related quality of life measured with the generic short-form health survey with 36 questions (SF36), EuroQol five Dimensions (EQ-5D) and the disease-specific Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    The SF36 is composed of 36 questions with standardized response options, organized in eight multi-item scales: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health.

    EQ-5D is a generic questionnaire of health for clinical and economic appraisal and consists of two parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Each dimension has 5 levels: from no problems, to severe problems. The MLHFQ is a validated questionnaire and consists of 21 items on patient perceptions concerning the effects of congestive heart failure on their physical, psychologic and socioeconomic lives. Response options are presented as 6 point scale.

    Measured: at 3, 6 and 12 months

Secondary outcomes (7)

  1. Number of patients who died of all causes

    Measured: at 12 months

  2. Number of heart failure related hospitalisations

    Measured: at 12 months

  3. Duration of heart failure related hospitalisations

    Measured: at 12 months

  4. Change in disease specific knowledge measured with the Dutch Heart Failure knowledge scale.

    The Dutch Heart Failure knowledge scale is a 15 item scale that covers items concerning heart failure knowledge in general, knowledge of heart failure treatment (including diet and fluid restriction) and heart failure symptoms and symptom recognition.

    Measured: 3, 6 and 12 months

  5. Change in heart function measured with blood values.

    N-terminal pro B-type natriuretic peptide (NT-proBNP) levels, renal function ('estimated Glomerular Filtration Rate '(eGFR)) will be used to determine the heart function.

    Measured: 6 and 12 months

  6. Change in use of website.

    The 'use of website' containing 4 questions targeting how often and how long patients are visiting the website and which parts specifically.

    Measured: 3, 6 and 12 months

  7. Cost-effectiveness

    To help calculate the cost-effectiveness of the interventions, use of medication, health care use (e.g. hospitalisations, visits to the general practitioner, the outpatient clinics, emergency department and admission to nursing homes) will be recorded.

    Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2012 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01755988
Sponsor's protocol ID
12-456
Status last verified
Jan 2017
First submitted
12 Dec 2012
Last updated
5 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36719715

  • 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.

    PubMed 30485612

  • 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.

    PubMed 26424105

Questions about this trial

What is this clinical trial studying?

A study testing Website and interactive platform with telemonitoring. in people with Heart Failure, run by UMC Utrecht at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-care behaviour measured with the validated European Heart Failure Self Care Behaviour Scale(EHFScB scale) (time frame: at 3, 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01755988, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.

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