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

January 4, 2017 updated by: F.H. Rutten, UMC Utrecht

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amstelveen, Netherlands
        • Amstelland Hospital
      • Arnhem, Netherlands
        • Rijnstate Hospital
      • Ede, Netherlands
        • Gelderse Vallei Hospital
      • Utrecht, Netherlands
        • Diakonessenhuis hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 3, 6 and 12 months
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.
at 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who died of all causes
Time Frame: at 12 months
at 12 months
Number of heart failure related hospitalisations
Time Frame: at 12 months
at 12 months
Duration of heart failure related hospitalisations
Time Frame: at 12 months
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.
3, 6 and 12 months
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 and 12 months
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.
3, 6 and 12 months
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.
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (ESTIMATE)

December 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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