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.
Other: Educational website (in addition to usual care).
Other: Website and interactive platform with telemonitoring.
|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.|
- 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.
- 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.
|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)|
|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.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755988
|Contact: Frans H Rutten, Dr, MD||0031(0)887568051||F.H.Rutten@umcutrecht.nl|
|Contact: Mannaerts, MD, PhD 0031(0)207557000|
|Contact: Willems, MD, PhD 0031(0)880058888|
|Gelderse Vallei Hospital||Recruiting|
|Contact: Schaafsma, MD, PhD 0031(0)318434343|
|Contact: Agema, MD, PhD 0031(0)882505000|
|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)|