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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01755988
First Posted: December 24, 2012
Last Update Posted: January 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Foundation: Zorg Binnen Bereik
Information provided by (Responsible Party):
F.H. Rutten, UMC Utrecht
  Purpose
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.

Condition Intervention
Heart Failure Other: Educational website (in addition to usual care). Other: Website and interactive platform with telemonitoring.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by F.H. Rutten, UMC Utrecht:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • Number of patients who died of all causes [ Time Frame: at 12 months ]
  • Number of heart failure related hospitalisations [ Time Frame: at 12 months ]
  • Duration of heart failure related hospitalisations [ Time Frame: at 12 months ]
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 450
Study Start Date: September 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Experimental: Educational website.
Educational website (in addition to usual care).
Other: Educational website (in addition to usual care).
Experimental: Website and interactive platform with telemonitoring.
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.
Other: Website and interactive platform with telemonitoring.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755988


Locations
Netherlands
Amstelland hospital
Amstelveen, Netherlands
Rijnstate hospital
Arnhem, Netherlands
Gelderse Vallei Hospital
Ede, Netherlands
Diakonessenhuis hospital
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Foundation: Zorg Binnen Bereik
Investigators
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)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: F.H. Rutten, Dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01755988     History of Changes
Other Study ID Numbers: 12-456
First Submitted: December 12, 2012
First Posted: December 24, 2012
Last Update Posted: January 5, 2017
Last Verified: January 2017

Keywords provided by F.H. Rutten, UMC Utrecht:
Telemedicine
Heart Failure
Self care
Quality of life
Mortality
Hospitalization

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases


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