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OpenTrials
Completed

NCT Number: NCT01755988

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amstelland hospital, Amstelveen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational website (in addition to usual care).

Other

Website and interactive platform with telemonitoring.

Other

Primary outcomes

  1. 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 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.

  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)

    Time frame: at 3, 6 and 12 months

    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.

Secondary outcomes

  1. Number of patients who died of all causes

    Time frame: at 12 months

  2. Number of heart failure related hospitalisations

    Time frame: at 12 months

  3. Duration of heart failure related hospitalisations

    Time frame: at 12 months

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

    Time frame: 3, 6 and 12 months

    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.

  5. Change in heart function measured with blood values.

    Time frame: 6 and 12 months

    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. Change in use of website.

    Time frame: 3, 6 and 12 months

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

  7. Cost-effectiveness

    Time frame: at 12 months

    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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Foundation: Zorg Binnen Bereik

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2012
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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