Healthy aging through internet counseling in the elderly
| ISRCTN | ISRCTN48151589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48151589 |
| Secondary identifying numbers | 305374 |
- Submission date
- 18/06/2014
- Registration date
- 05/09/2014
- Last edited
- 07/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Academic Medical Centre Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Study information
| 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 |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant 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 |
| 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 acronym | HATICE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2015 |
| Completion date | 01/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 2600 |
| Total final enrolment | 2724 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 01/07/2016 |
Locations
Countries of recruitment
- Finland
- France
- Netherlands
Study participating centre
1105 AZ
Netherlands
Sponsor information
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Results and Publications
| Intention to publish date | 15/11/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of study results in a high-impact peer reviewed journal. |
| IPD sharing plan | 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/06/2016 | Yes | No | |
| Statistical Analysis Plan | 12/06/2017 | 27/06/2017 | No | No | |
| Results article | qualitative sub-study results | 21/01/2018 | Yes | No | |
| Results article | qualitative sub-study results | 06/06/2019 | 02/06/2020 | Yes | No |
| Results article | qualitative study results | 06/08/2020 | 10/08/2020 | Yes | No |
| Results article | results | 01/12/2019 | 17/12/2020 | Yes | No |
| Other publications | Factors predicting engagement in the intervention | 13/12/2021 | 07/04/2022 | Yes | No |
Additional files
- ISRCTN48151589_SAP_12Jun17.pdf
- Uploaded 27/06/2017
Editorial Notes
07/04/2022: Publication reference added.
17/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
10/08/2020: Publication reference added.
02/06/2020: Publication reference added.
28/10/2019: The intention to publish date was changed from 31/03/2019 to 15/11/2019.
17/08/2018: Publication reference added.
27/06/2017: Uploaded statistical analysis plan. Please note that this was originally submitted on June 13th 2017.
13/06/2017: The recruitment end date has been updated from 01/07/2017 to 01/07/2016. The Plain English summary has been reviewed and updated to reflect the trial end date. Added participant level data sharing statement.
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.
