To investigate whether an interactive internet-based intervention strategy targeting vascular and lifestyle-related risk factors can lead to improvement of cardiovascular risk profile and prevention of cardiovascular disease and whether this in turn…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Central nervous system vascular disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is a weighted composite score based on
z-scores of the difference between baseline and 18 months follow-up values of
systolic blood pressure, cholesterol and BMI.
Secondary outcome
Main secondary endpoints are z-scores of the individual risk factors, 10-year
risk of cardiovascular disease (Framingham risk score), number of risk factors
on target, incident cardiovascular disease, CAIDE dementia risk-score,
disability, depression, cognitive decline and mortality.
Background summary
Older persons with multiple cardiovascular risk factors and/or cardiovascular
disease are at increased risk of poor clinical outcome: myocardial infarction,
stroke, cognitive decline, dementia and death. Adherence to effective and
evidence-based interventions is thought to play an important role in
prevention. Improved patient engagement has considerable potential to improve
management of individuals at risk. In HATICE an innovative Internet platform to
optimise management of cardiovascular risk factors in older persons is
developed and will be tested for efficacy in a randomised controlled clinical
trial.
Study objective
To investigate whether an interactive internet-based intervention strategy
targeting vascular and lifestyle-related risk factors can lead to improvement
of cardiovascular risk profile and prevention of cardiovascular disease and
whether this in turn may prevent or delay the onset of cognitive decline and
dementia.
Study design
European, multi-centre, investigator initiated, open-label blinded endpoint
(PROBE), parallel group, randomised controlled trial.
Intervention
The intervention group gets access to an interactive internet platform
supported by a coach to facilitate and encourage self-management of risk
factors and lifestyle change. The control group receives care as usual and
access to an internet platform similar in appearance, but only providing
general information on a healthy lifestyle, without the interactive features.
Study burden and risks
All participants have two site visits (baseline and 18 months). At both visits
a venous blood sample will be taken. During the site visits the participants
get a physical examination and are requested to fill out questionnaires on
disability, depression, physical activity, diet, quality of life and
self-management. A short neuropsychological test battery will be applied.
Participants in the intervention group are recommended to visit the internet
platform at least once a week for 20 minutes and monitor their lifestyle,
although intensity of use can be adapted according to participant's wishes. If
participants manage to improve their risk profile they might benefit from this,
since this might reduce their risk for cardiovascular disease.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age * 65 years
- Available informant
- * two cardiovascular risk factors and/or manifest cardiovascular disease defined as:
cardiovascular risk factors;
* hypertension, defined by either:
o diagnosis by specialist or a general practicioner
o currently on anti-hypertensive drugs
o if < 80 years: ><=140/90; if ><= 80 years: Systolic BP ><= 160
* dyslipidemia, defined by either:
o diagnosis of dyslipedemia by specialist or GP
o use of lipid-lowering drug (this will include persons who have no dyslipeima, but use it after a previous cardiovascular disease; this is acceptable, since these people automatically fulfil inclusion criteria as well)
o baseline cholesterol or TC/HDL ratio or LDL above or below cut-offs according to European guidelines
* overweight, defined by either:
o BMI >30
o Waist circumference men >102 cm, women >88 cm
* active smoking (self-reported, any tobacco use)
* lack of physical exercise (self-reported) defined as below the WHO norm of 5 times a week 30 minutes (or a total of 150 minutes per week) of intermediate exercise.
OR
* History of cardiovascular disease: stroke/TIA, myocardial infarction, angina pectoris, peripheral arterial disease and/or diabetes mellitus (DM)
Exclusion criteria
- Previously diagnosed dementia as diagnosed by a GP or specialist
- Mini Mental State Examination score <24
- Any condition expected to limit 18-months compliance and follow-up
- Computer illiteracy, defined as unable to send an email
- Severe visual impairment interfering with operating a computer
- Participating in another randomised controlled trial
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 | NL48261.018.14 |