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 January 2018
Who is funding the study?
European Unions' Seventh Framework Programme
Who is the main contact?
Dr E. Richard
E.richard@amc.nl
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
305374
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
Acronym
HATICE
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 (France), 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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Prevention
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.nl Finnish website: www.terveika.fi French website: www.resteractif.fr
Condition
Cardiovascular prevention
Intervention
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
Other
Phase
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
01/01/2015
Overall trial end date
01/01/2018
Reason abandoned
Eligibility
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:
3.1.1.1. Diagnosis by specialist or GP
3.1.1.2. Currently on anti-hypertensive drugs
3.1.1.3. Baseline BP: if < 80 years: ≥ 140/90 mmHg; if ≥ 80 years: Systolic BP ≥ 160
3.1.2. Dyslipidemia, defined by any of the following:
3.1.2.1. Diagnosis of dyslipidemia by specialist or GP
3.1.2.2. 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)
3.1.2.3. Baseline total cholesterol ≥ 5 mmol/L and/or LDL ≥ 2.5 mmol/L
3.1.3. Overweight, defined by any of the following:
3.1.3.1. BMI ≥ 30
3.1.3.2. 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
or
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
Patient
Age group
Senior
Gender
Both
Target number of participants
2600
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
01/01/2015
Recruitment end date
01/07/2016
Locations
Countries of recruitment
Finland, France, Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
Funders
Funder type
Government
Funder name
Seventh Framework Programme, grant agreement No 305374
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Planned publication of study results in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. E. Richard (e.richard@amc.uva.nl)
Intention to publish date
31/03/2019
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27288376
Publication citations
Additional files
- ISRCTN48151589_SAP_12Jun17.pdf Uploaded 27/06/2017