Effectiveness of a Website and Telemonitoring in Patients With Heart Failure.
|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.|
|ClinicalTrials.gov Identifier: NCT01755988|
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : January 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Educational website (in addition to usual care). Other: Website and interactive platform with telemonitoring.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|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.
- 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.
- 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.
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
|Gelderse Vallei Hospital|
|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)|