Clinical trial NCT01755988: Effectiveness of a Website and Telemonitoring in Patients With Heart Failure.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Telemedicine
Heart Failure
Self care
Quality of life
Mortality
Hospitalization
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Foundation: Zorg Binnen Bereik
First posted: 2012-12-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in self-care behaviour measured with the validated European Heart Failure Self Care Behaviour Scale(EHFScB scale)
timeFrame: at 3, 6 and 12 months
measure: 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)
timeFrame: at 3, 6 and 12 months
Secondary outcomes:
measure: Number of patients who died of all causes
timeFrame: at 12 months
measure: Number of heart failure related hospitalisations
timeFrame: at 12 months
measure: Duration of heart failure related hospitalisations
timeFrame: at 12 months
measure: Change in disease specific knowledge measured with the Dutch Heart Failure knowledge scale.
timeFrame: 3, 6 and 12 months
measure: Change in heart function measured with blood values.
timeFrame: 6 and 12 months
measure: Change in use of website.
timeFrame: 3, 6 and 12 months
measure: Cost-effectiveness
timeFrame: at 12 months
Other outcomes:
Locations:
city: Amstelveen
country: Netherlands
facility: Amstelland hospital
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
city: Ede
country: Netherlands
facility: Gelderse Vallei Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis hospital
Study officials:
affiliation: University Medical Center Utrecht (UMC Utrecht)
name: Arno W Hoes, Dr. MD
role: STUDY_DIRECTOR
affiliation: University Medical Center Utrecht (UMC Utrecht)
name: Frans H Rutten, Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.