The objective of the proposed study is to evaluate the efficacy on risk factor management and toevaluate cost-effectiveness of an internet-based risk factor management program for patients at highcardiovascular risk.The research questions areā¦
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
After 1 year all patients (usual care and internet-based care) are asked to
return to the clinic for an
evaluation visit to obtain the same information on vascular risk factors and
risk indicators as was done
as at baseline: Total cholesterol, LDL-cholesterol, HDL-cholesterol,
triglycerides, glucose, body mass
index, waist circumference, blood pressure and smoking. A questionnaire will be
used to gather data about health-care use, labour, self-care, exercise,
food-choices, self-efficacy, social support, and quality of life.
At the beginning of the study and at the end of the intervention period, the
10-year absolute cardiovascular risk will be carculated using the Framingham
risk-score. The difference in 10-year risk between end-of-study (after 1 year)
and baseline will serve as primairy summary risk outcome. The primairy outcome
is the relative difference in absolute risk between the intervention group and
copntrol group.
Secondary outcome
The absolute change in each risk factor (the level at 1 year minus the level at
baseline) and the percentage of patients
reaching the treatment goal for each risk factor will be calculated and serve
as secondary outcome.
Change in self-management related parameters and actual health behavior between
the intervention group and the control group will be related to achieved
treatment goals.
Background summary
Vascular diseases are among the most prevalent medical disorders in the
Netherlands, leading to
premature death, (severe) disability and reduced quality of life. The health
care costs for patients and
society are increasing. In the last 10 years very effective treatment
strategies for reducing cardiovascular
risk have been evaluated in numerous large randomized clinical trials. It has
become very clear that
blood pressure lowering, LDL-cholesterol lowering, smoking cessation, weight
control and exercise are
the principle targets for risk reduction in patients at high risk for
developing new vascular events. Across
trials in different high-risk populations, the average reduction in relative
risk for cholesterol-lowering is
30%, blood pressure lowering 30%, stop smoking 20-40% and weight reduction
30-40%. In the recently
issued CardioVascular Risk Management (CVRM 2006) guideline in the Netherlands,
these
interventions are considered to be crucial in risk reduction (9,10).
Nevertheless, poor management of
vascular risk factors leaves many patients unnecessarily at increased risk. New
healthcare strategies need to be developed to deal with this health problem in
an increasing number of patients.(11-15) Given
the fact that more patients survive an acute cardiovascular event, the number
of high risk patients will
further increase. Therefore new healthcare strategies not only need to be more
effective but must also
be very efficient. It is expected that using current internet technology and
aiming at improving self
management capacity of patients by providing treatment and medical support in
their own home, away
from the high-cost hospital environment, this strategy could be very effective
as well very efficient in
terms of costs.
Study objective
The objective of the proposed study is to evaluate the efficacy on risk factor
management and to
evaluate cost-effectiveness of an internet-based risk factor management program
for patients at high
cardiovascular risk.
The research questions are defined as follows:
- Is an internet-based vascular risk factor management program on top of usual
care more effective than
usual care alone in reducing vascular risk factors in patients with a recent
clinical manifestation of a
vascular disease?
- Is an internet-based vascular risk factor management program for reducing
vascular risk factors in
patients with a recent clinical manifestation of a vascular disease
cost-effective?
Study design
Randomized, non-blinded trial
Intervention
Patients randomised to the internet-program will receive an internet-based risk
factor
management program on top of usual care for 12 months. Patients will be invited
for a visit to the nurse
practitioner in the hospital. During this visit patients receive information on
the treatment advices and
corresponding risk factors, receive instructions on the internet program and
receive a username and
password for their personalized website. The following contacts between patient
and nurse practitioner
will be by the internet. Depending on presence of risk factors that need
(additional) treatment, a tailored
internet file is made for each individual patient. The opening page gives an
overview of all the status of
all risk factors (green=good, yellow=close to goal, red=needs attention),
medication use and (new)
messages from the nurse. Within the program, each risk factor is displayed on a
separate internet page
containing a history of risk factor measurements (e.g. blood pressure or
LDL-cholesterol, etc), current
treatment, treatment goal, advices from the nurse, correspondence between nurse
and patient, news
items of that particular risk factor. Patients are encouraged to log-in
frequently and to fill in new
measurements (blood pressure, weight, smoking status, cholesterol) and to read
and send messages.
The internet program is linked to the www.vaatcentrum.nl website of the UMCU
for general information
on risk factors and vascular diseases. The nurse practitioner is able to view
all files and pages from all
patients and has access to pages with a total overview of the current status of
risk factors, last log-in
attempts of each patient and new messages send by patients. In general the
nurse practitioner will log-in
every day and this overview enables her to very efficiently reply to messages
send by patients and to
send messages to patients not using the program regularly. If necessary
telephone contact can be
made. Change in medication regimen can be made by sending a pharmacy-recipe.
Patients are
encouraged to self-measure blood pressures at home. If applicable, the patients
has the option to log-in
at the office of the general practitioner for direct viewing and addition of
information about vascular risk
factors. In this way the general practitioner can be actively involved in risk
factor management and has
access to all patient information regarding risk factor management. It is up to
the patient and general
practitioner whether this opportunity provided by the program is taken and
whether the general
practitioner will be granted with full access to his/her medical information on
vascular risk factors. For
measuring plasma lipids and/or glucose patients receive laboratory forms from
the nurse by mail for
drawing blood in their own city or at the UMCU or Rijnstate Hospital, whatever
is convenient for the
patient. The nurse practitioner works according the guidelines described in the
latest version of
*handboek voor verpleegkundig specialisten' (6) based on the national CVRM 2006
guideline for the
diagnosis and treatment of vascular risk factors.
The care delivered by the nurse practitioner with the internet program is on
top of usual care and can not
replace the care given by the treating physician in the hospital and the
general practitioner. The
internet-based care should be seen as on-top-of usual care. A possible draw
back of the web-based risk
factor management program is that the nurse practitioner is likely to be
focussed on the protocol
('handboek') and on vascular risk factors and by using internet there are
limited face-to-face contacts
with the patients. Therefore co-morbidity may not become evident. At the start
and during the program
the nurse practitioner will encourage patients to contact their own doctor(s)
for medical issues, whether
or not related to vascular diseases and/or vascular risk factors. At the end of
the study (after 12 months)
patients randomized to the internet program are asked to report visits to
doctors, diagnoses made during
the 12 months and medication use, in order to evaluate whether additional
diagnoses were made that
may have been missed by the nurse practitioner unless the fact that the nurse
practitioner is vigorously
supervised by an internist.
Study burden and risks
n.a.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Patients with an recent clinical manifestation of atherosclerosis in the coronary, cerebral or peripheral arteries undergoing a standardized risk factor screening program revealing 2 or more treatable risk factors. Patients are between 18 and 80 years of age, capable to read and write Dutch, independent in daily activities and have access to internet at home.
Exclusion criteria
No access to internet.
Malignant disease, dependancy in daily activities
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 |
---|---|
CCMO | NL22261.041.08 |