Effectiveness of a Website and Telemonitoring in Patients With Heart Failure.
Effectiveness of an Interactive Web-based Platform and a Disease Specific Information Website in Patients With Heart Failure: a 3-arm Randomised Trial.
1 other identifier
interventional
450
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Sep 2013
4 active sites
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
December 12, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 5, 2017
January 1, 2017
2.2 years
December 12, 2012
January 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
at 3, 6 and 12 months
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.
at 3, 6 and 12 months
Secondary Outcomes (7)
Number of patients who died of all causes
at 12 months
Number of heart failure related hospitalisations
at 12 months
Duration of heart failure related hospitalisations
at 12 months
Change in disease specific knowledge measured with the Dutch Heart Failure knowledge scale.
3, 6 and 12 months
Change in heart function measured with blood values.
6 and 12 months
- +2 more secondary outcomes
Study Arms (3)
Usual care
NO INTERVENTIONEducational website.
EXPERIMENTALEducational 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Foundation: Zorg Binnen Bereikcollaborator
Study Sites (4)
Amstelland hospital
Amstelveen, Netherlands
Rijnstate hospital
Arnhem, Netherlands
Gelderse Vallei Hospital
Ede, Netherlands
Diakonessenhuis hospital
Utrecht, Netherlands
Related Publications (3)
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.
PMID: 36719715DERIVEDWagenaar 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.
PMID: 30485612DERIVEDWagenaar 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.
PMID: 26424105DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arno W Hoes, Dr. MD
University Medical Center Utrecht (UMC Utrecht)
- PRINCIPAL INVESTIGATOR
Frans H Rutten, Dr. MD
University Medical Center Utrecht (UMC Utrecht)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
December 12, 2012
First Posted
December 24, 2012
Study Start
September 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 5, 2017
Record last verified: 2017-01