Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Older people that have cardiovascular disease (for example, heart disease, stroke) or have a number of risk factors that make them more likely to develop cardiovascular disease (for example, high blood pressure, diabetes, high cholesterol levels) are at an increased risk of a heart attack (myocardial infarction), stroke, dementia and death. Effective treatment for cardiovascular disease is available, but may not be enough to prevent serious health problems in cases where the patient has a number of risk factors. Being able to manage these risk factors is therefore thought to have an important preventive role and getting the patients actively involved is also likely to be beneficial. HATICE is an internet programme (intervention) that has been developed to help older people to manage their own health and, in particular, manage their pre-existing cardiovascular risk factors. Here, we want to find out if such an intervention can help prevent cardiovascular disease and also prevent, or at least delay, the onset of dementia.

Who can participate?
Adults that are at least 65 years of age, have two or more cardiovascular risk factors or have a history of cardiovascular disease.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are able to use an interactive internet programme that helps and encourages them to make changes to their lifestyle and manage their own risk factors. Those in group 2 are given their usual care and also access to an internet programme similar in appearance to that used by group 1 participants, but only providing general information on a healthy lifestyle, without the interactive features. Each participants BMI, blood pressure and blood cholesterol levels are taken before the start of the trial and 18 months later. They are also asked to fill out questionnaires on disability, depression, physical activity, diet, quality of life and self-management. They are also tested for dementia.

What are the possible benefits and risks of participating?
All participants have a blood sample taken at before the start of the trial and 18 months later.
Participants in group 1 may benefit from the interactive internet programme and find that their risk of cardiovascular disease is reduced.

Where is the study run from?
The HATICE study has been set up by the Academic Medical Centre (AMC) in Amsterdam, the University of Eastern Finland (UEF), Institut National de la Sante et de la Recherche Medicinale (INSERM) in France, the Karolinska Institutet in Sweden and the University of Cambridge in England. Recruitment of participants will take place in three countries (Netherlands, Finland, France).

When is study starting and how long is it expected to run for?
January 2015 to June 2017

Who is funding the study?
European Unions' Seventh Framework Programme

Who is the main contact?
Dr E. Richard

Trial website

Contact information



Primary contact

Dr Edo Richard


Contact details

Academic Medical Centre Amsterdam
Meibergdreef 9
1105 AZ

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Healthy aging through internet counseling in the elderly: a European, multi-centre, investigator initiated, open-label blinded endpoint (PROBE), parallel group, randomised controlled trial



Study hypothesis

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.

Ethics approval

1. Northern Savonia Hospital District Research Ethics Committee (Finland), 10/06/2014, ref: 35/2014
2. Medical committee of the Academic Medical Center (Netherlands), 26/06/2014, ref: METC 2014_126.
3. Comité de Protection des Personnes (CPP) Sud Ouest et Outre Mer, 24/09/2014, ref: 2014-A01287-40

Study design

European multi-centre investigator-initiated open-label blinded endpoint (PROBE) parallel-group randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Currently not available in web format, please use the contact details below to request a patient information sheet.For each country we will have a website where patient information will be available. These are currently under construction. Dutch website: www.capio-onderzoek.nlFinnish website: French website:


Cardiovascular prevention


1. The intervention group is provided with access to an interactive internet platform supported by a coach to facilitate and encourage self-management of risk factors and lifestyle change.
2. 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.

Intervention type



Not Applicable

Drug names

Primary outcome measures

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. The rationale behind this primary outcome is that:
1. 18-months follow-up is too short for a significant number of clinical outcome events even when using this sample size
2. Only measurable risk factors are included (self-reported factors such as physical exercise are sensitive to bias)
3. This will allow for very sensitive and direct assessment of the risk factors we target
This has the potential caveat of making a type I error, but even a very small effect on cardiovascular risk profile could have considerable effect at the population level (prevention paradox).

Secondary outcome measures

Main secondary outcomes are:
1. Z-scores of individual components of the primary outcome only in persons who have this risk score at baseline
2. Improvement in estimated 10-year cardiovascular disease risk based on the Framingham cardiovascular disease risk score (measured at 18 months)
3. Incident cardiovascular disease (stroke/TIA, myocardial infarction, peripheral arterial disease, heart failure)
4. Improvement of the number of measurable risk factors (blood pressure, BMI, cholesterol, glycated haemoglobin)
5. Improvement of the number of self-reported risk factors (physical exercise, diet)
6. Mortality
7. Disability
8. Cognitive decline
9. CAIDE dementia risk-score
10. Physical fitness (short physical performance battery)
11. Depression (15-item Geriatric Depression Scale)
12. Cost-effectiveness

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Age ≥ 65 years
2. Available informant
3. ≥ 2 cardiovascular risk factors and/or manifest cardiovascular disease defined as:
3.1. Cardiovascular risk factors:
3.1.1. Hypertension, defined by any of the following: Diagnosis by specialist or GP Currently on anti-hypertensive drugs Baseline BP: if < 80 years: ≥ 140/90 mmHg; if ≥ 80 years: Systolic BP ≥ 160
3.1.2. Dyslipidemia, defined by any of the following: Diagnosis of dyslipidemia by specialist or GP Use of lipid-lowering drug (this will include persons who have no dyslipidemia, but use it after a previous cardiovascular disease; this is acceptable, since these people automatically fulfil inclusion criteria as well) Baseline total cholesterol ≥ 5 mmol/L and/or LDL ≥ 2.5 mmol/L
3.1.3. Overweight, defined by any of the following: BMI ≥ 30 Waist circumference men ≥102 cm, women ≥88 cm
3.1.4. Active smoking (self-reported, any tobacco use)
3.1.5. Lack of physical exercise (self-reported) defined as below the WHO norm of 30 minutes 5 times a week (or a total of 150 minutes per week) of intermediate exercise
3.2. History of cardiovascular disease:
3.2.1. Stroke/transient ischemic attack (TIA)
3.2.2. Myocardial infarction
3.2.3. Angina pectoris
3.2.4. Peripheral arterial disease
3.2.5. Diabetes mellitus (DM)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Previously diagnosed dementia as diagnosed by a GP or specialist
2. Mini Mental State Examination score <24
3. Any condition expected to limit 18-months compliance and follow-up
4. Computer illiteracy, defined as unable to send an email and/or do a simple Google search
5. Severe visual impairment interfering with operating a computer
6. Participating in another randomised controlled trial

Recruitment start date


Recruitment end date



Countries of recruitment

Finland, France, Netherlands

Trial participating centre

Academic Medical Centre
1105 AZ

Sponsor information


Academic Medical Centre Amsterdam (Netherlands)

Sponsor details

Meibergdreef 9
1105 AZ

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Seventh Framework Programme, grant agreement No 305374

Alternative name(s)

European Union Seventh Framework Programme, EU Seventh Framework Programme, European Commission Seventh Framework Programme, EC Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government



Results and Publications

Publication and dissemination plan

Planned publication of study results in a high-impact peer reviewed journal.

Intention to publish date


Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2016 protocol in:

Publication citations

Additional files

Editorial Notes

08/07/2016: The publication and dissemination plan and availability of participant level data have been added. 04/07/2016: The recruitment end date has been updated from 01/06/2017 to 01/07/2017 and the overall trial end date has been updated from 01/06/2017 to 01/01/2018. In addition, the target number of participants has changed from 4250 to 2600. 13/06/2016: Publication reference added. 24/03/2016: Ethics approval information added.