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

This study is currently recruiting participants.
Verified September 2013 by UMC Utrecht
Sponsor:
Collaborator:
Foundation: Zorg Binnen Bereik
Information provided by (Responsible Party):
F.H. Rutten, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01755988
First received: December 12, 2012
Last updated: September 20, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
  • Number of heart failure related hospitalisations [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Duration of heart failure related hospitalisations [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Change in disease specific knowledge measured with the Dutch Heart Failure knowledge scale. [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 750
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755988

Contacts
Contact: Frans H Rutten, Dr, MD 0031(0)887568051 F.H.Rutten@umcutrecht.nl

Locations
Netherlands
Amstelland hospital Recruiting
Amstelveen, Netherlands
Contact: Mannaerts, MD, PhD    0031(0)207557000      
Rijnstate hospital Recruiting
Arnhem, Netherlands
Contact: Willems, MD, PhD    0031(0)880058888      
Gelderse Vallei Hospital Recruiting
Ede, Netherlands
Contact: Schaafsma, MD, PhD    0031(0)318434343      
Diakonessenhuis hospital Recruiting
Utrecht, Netherlands
Contact: Agema, MD, PhD    0031(0)882505000      
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

No publications provided

Responsible Party: F.H. Rutten, Dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01755988     History of Changes
Other Study ID Numbers: 12-456
Study First Received: December 12, 2012
Last Updated: September 20, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Telemedicine
Heart Failure
Self care
Quality of life
Mortality
Hospitalization

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014