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

UMC Utrecht

Status: Completed

Conditions: Heart Failure

Treatments: Other: Educational website (in addition to usual care).; Other: Website and interactive platform with telemonitoring.

Study type: Interventional

Funder types: Other

Identifiers

NCT01755988

12-456

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

Usual care

No Intervention group

Educational website.

Experimental group

Description:

Educational website (in addition to usual care).

Treatment:

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

Website and interactive platform with telemonitoring.

Experimental group

Description:

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.

Treatment:

Other: Website and interactive platform with telemonitoring.