- To assess whether a disease specific educational website improves self-care behaviour and quality of life of patients with HF as compared to usual care.- To assess whether a disease-specific educational website plus an interactive web-based…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are self care behaviour and quality of life measured with
the validated European Heart Failure Self Care Behaviour Scale (EHFScB scale)
and the short-form health survey with 36 questions (SF36), EuroQol 5 Dimensions
(EQ-5D), and Minnesota Living with Heart Failure Questionnaire (MLHFQ)
respectively.
Secondary outcome
Secondary outcome are all-cause mortality, HF related hospitalisations,
duration of HF related hospitalisations and disease specific knowledge measured
with the Dutch Heart Failure knowledge scale, heart function and evaluation of
use of website measured with the *use of website* and website user satisfaction
(WUS) questionnaire. A cost-effectiveness analysis will be part of the study.
Background summary
Heart failure (HF) is a major health care problem. Ageing of the population and
improved survival after acute coronary events will further increase the number
of patients affected. Notably hospital admissions for exacerbations of HF place
a great burden on the patients and the health care system. Efficient
incorporation of a disease-specific educational website and telemonitoring
facilities may increase quality of life and functional capacity of patients,
while partly reducing the burden on health care workers and thus increasing the
number of patients they can care for.
Study objective
- To assess whether a disease specific educational website improves self-care
behaviour and quality of life of patients with HF as compared to usual care.
- To assess whether a disease-specific educational website plus an interactive
web-based platform with telemonitoring facilities improves self-care behaviour
and quality of life of patients with HF as compared to usual care.
- To assess whether a disease-specific educational website plus an interactive
web-based platform with telemonitoring facilities improves self-care behaviour
and quality of life of patients with HF as compared to a disease-specific
educational website alone.
- To assess whether both interventions result in lower all-cause mortality, HF
related hospitalisations, duration of HF related hospitalisations, improve
knowledge about the HF and its treatment and influences HF biomarkers.To
determine whether the interventions are cost-effective.
Study design
A prospective, three-arm parallel randomised trial.
The study will be conducted in about ten HF outpatient clinics in the
Netherlands. Individual patients will be randomly allocated to one of the three
study arms and followed for twelve months.
Intervention
Arm 1. Usual care; 2. Disease specific educational website (in addition to
usual care). This website is the very recently completed Dutch translation of
the European informative website about HF developed by the Heart Failure
Association of the European Society of Cardiology (ESC). The website is
targeted at patients, their relatives, and carers
(www.heartfailurematters.org). 3. Adjusted care pathway, including both the
educational website and an interactive web-based platform with telemonitoring
facilities. In this arm all routine consultations with HF nurses and GP will be
substituted by this combination of telemonitoring facilities connected to an
interactive web-based platform plus the Dutch version of the ESC website on HF.
Study burden and risks
Randomised patients will not be exposed to specific health risks. The main
burden for participants and their care takers will be time and effort taken to
fill out questionnaires (all patients); giving blood; receive training on the
information website (arm two) and to receive training on the interactive care
platform including daily measurements of body weight, blood pressure and heart
rate (arm three).
Universiteitsweg 100
Utrecht 3584 CG
NL
Universiteitsweg 100
Utrecht 3584 CG
NL
Listed location countries
Age
Inclusion criteria
- HF established according to the guidelines of the European Society of Cardiology (ESC), and confirmed with echocardiography at least three months ago.
- 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 email.
- Inability to work with internet and e-mail.
- Inability of the patient and his/her family or care takers to read and understand Dutch.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 00000000000 |
| CCMO | NL40993.041.12 |