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

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755988
• Other study ID #: 12-456
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: January 4, 2017
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

• Website and interactive platform with telemonitoring.

Locations

Country	Name	City	State
Netherlands	Amstelland hospital	Amstelveen
Netherlands	Rijnstate hospital	Arnhem
Netherlands	Gelderse Vallei Hospital	Ede
Netherlands	Diakonessenhuis hospital	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Foundation: Zorg Binnen Bereik

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Number of patients who died of all causes		at 12 months	Yes
Secondary	Number of heart failure related hospitalisations		at 12 months	Yes
Secondary	Duration of heart failure related hospitalisations		at 12 months	No
Secondary	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.	3, 6 and 12 months	No
Secondary	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.	6 and 12 months	No
Secondary	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.	3, 6 and 12 months	No
Secondary	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.	at 12 months	No