Servizio Comunitario di Informazione in materia di Ricerca e Sviluppo - CORDIS

Periodic Report Summary 2 - HATICE (Healthy Aging Through Internet Counselling in the Elderly)

Project Context and Objectives:
People over 65 with multiple cardiovascular risk factors or manifest cardiovascular disease are at increased risk of poor clinical outcome: myocardial infarction, stroke, dementia and death. Insufficient adherence to effective and evidence-based interventions plays an important role in suboptimal prevention. Improved patient engagement has great potential to improve management of individuals at risk.

The overall aim of HATICE is to develop a comprehensive, innovative internet-based interactive intervention strategy for optimisation of management of elderly with multiple cardiovascular risk factors or cardiovascular disease. In HATICE, this widely applicable and generic intervention strategy is immediately put to the test of an investigator-initiated randomised controlled trial.

Current knowledge on treatment of cardiovascular risk factors mostly comes from trials aiming at one specific factor only, e.g. blood pressure, cholesterol or blood glucose levels, studied in a specific research setting. Little is known about the effect of multi-component interventions in a ‘real world’ setting. Presence of several vascular risk factors can lead to a cumulative increased risk and an intervention aiming at multiple risk factors at the same time is therefore a potentially powerful tool. The European Dementia Prevention Initiative (EDPI, has been launched by some of the HATICE partners prior to the start of HATICE. Participants in EDPI are all doing investigator-initiated RCTs investigating whether a multi-component intervention aiming at vascular and life-style related risk factors can decrease the risk of cardiovascular disease and dementia. Data sharing and pooled analyses of three recently completed RCTs will guarantee optimal use of the existing infrastructure and forms an excellent starting point for HATICE.

To achieve the general aim, the HATICE consortium performed the following activities:
- The consortium built a data sharing platform to upload, exchange, pool and analyse the anonymised data from three large recently completed clinical trials on multi-component vascular interventions in the elderly: FINGER, MAPT and PreDIVA in a security-protected area for the exchange and standardisation of data for pooled analyses.
- Data from these three ongoing trials are used to explore efficacy and feasibility of various treatment regimens on metabolic, lifestyle and hard clinical endpoints and in addition the adherence to these regimens is evaluated and barriers that prevent participation are identified.
- A generic intervention strategy is designed that is applicable under different health care systems and in line with local and national guidelines with some room for minor cultural/country specific adaptations to ensure possible implementation in other European countries after the trial.
- An innovative, user-friendly and interactive internet platform for self-management of vascular diseases in the elderly is developed. Interactive support by a coach and monitoring of adverse events is integrated in this platform.
- The efficacy of access to this new internet platform is being evaluated in a randomised controlled trial in 4250 elderly during 18 months follow up. Elderly randomised to the control condition receive regular care with access to a basic internet platform, similar in appearance, but without support from a coach. The intervention group receive tailor-made lifestyle advise from a coach which is monitored through and supported by the internet platform.

This flexible internet-based intervention strategy can be easily translated and adapted for use in different health-care systems in the EU. Meanwhile stakeholders are identified and the general public is kept informed regarding this study and the progress made through the website and national television programs.

Project Results:
The HATICE website was launched and seven face-to-face consortium combined with General Assembly meetings were organised.

In addition, a data sharing platform for pooled analysis of the ongoing trial data has been developed. Within this secured platform anonymized data can be exchanged between consortium partners and the data from each trial is recoded to perform uniform analyses on the pooled datasets. In addition, more prospective tools, allowing us to go further into representation of data sets as well as data traceability, leading to richer data handling were developed. Based on the data from the data sharing platform factors associated with (barriers to) participation, dropout and adherence have been identified.
To obtain input for optimization of the intervention, focus groups with the target population and with nurses have been conducted in France, the Netherlands and Finland, and in addition meetings were organised with patient advocacy groups and Healthcare workers in the Netherlands and Finland. The meetings with patient advocacy groups and patient organizations active in geriatric settings have had a twofold scope: gather input relevant for the design of a user-friendly intervention platform and for the intervention protocol and introduce/disseminate HATICE.
Based on the specifications assembled within the consortium, the intervention platform was designed. Besides the organised focus groups also two test meetings were organised to test the developed platform with a small group of elderly. The whole iterative process resulted in the development of the HATICE internet platform which was developed for both the control and intervention group.
The HATICE intervention was designed based on the common grounds in the guidelines of the recruiting countries involved resulting in 7 targeted health factors: Blood pressure, Cholesterol, Diabetes, Nutrition, Physical activity, Smoking and Weight. Based on the available information at baseline the intervention participants are advised to act on up to 3 of these health factors via the platform complemented with the support of a coach. Elderly randomised to the control condition receive regular care with access to a basic internet platform, similar I appearance but without support from a coach to make lifestyle changes. Ethical approval has been obtained by all three recruiting countries.

Currently the trial is up and running. Recruitment for the trail started in March 2015 in Finland and the Netherlands and in May 2015 in France. By the end of 2015, we have recruited in total 1434 participants in the trial; 951 in the Netherlands, 423 in Finland and 60 in France. The aim is to recruit in total 4250 participants.

The project and the consortium have been presented to the scientific community, general public, patient organizations, policymakers, industry and healthcare specialists through several dissemination activities.

Potential Impact:
Expected final results:
-Through the development of an effective internet-based intervention strategy the HATICE consortium expects to reduce (the risk for) new cardiovascular events and possibly also dementia in the elderly population.
-The internet platform will allow for tailor-made interventions specifically suited to the needs of senior-citizens and will monitor adverse events.
-The platform will engage and thus empower older persons by shifting the locus of control from traditional health care providers to the elderly themselves.
-By comparing and analyzing three currently ongoing studies, the HATICE consortium will identify characteristics that either impede (or stimulate) optimal management of multiple cardiovascular diseases or risk factors, specifically in older persons, which will be highly valuable to further optimize the HATICE intervention.
-The HATICE consortium will also deliver a data sharing platform which was developed within HATICE for analysis of the ongoing trial data.
-With the running of the RCT in 3 countries (France, Finland and the Netherlands) the consortium will optimize health advice to elderly with multiple cardiovascular diseases or risk factors irrespective of the country or health system.
-The exploratory cost-effectiveness study performed within HATICE will indicate the impact of the HATICE internet intervention on healthcare costs.
-The developed HATICE internet intervention platform will be a web-based, cloud deployable solution with minimal total cost of ownership.

Potential impact and use of the final results:
-The developed effective internet-based intervention strategy will be easily adaptable for use in the other EU member states and their health-care systems.
-The expected decrease in new cardiovascular events and dementia is expected to result in a substantial lowering of healthcare costs. Because of the high costs that are associated with stroke, myocardial infarction and cognitive impairment it is highly likely that any risk reduction will eventually lead to lowering of healthcare costs.
-The HATICE trial will identify characteristics that either impede (or stimulate) optimal management of multiple cardiovascular diseases or risk factors, specifically in older persons which will be highly valuable for future intervention studies in this area.
-Knowledge on the specific effects of prevention will enable health policy stakeholders throughout the EU to optimize national prevention programs.
-Besides the expected long term reduction of healthcare costs due to reduced strokes, myocardial infarction and delayed onset of cognitive impairment, also short term reductions of health care costs can be achieved because the internet platform itself can reduce the need for scheduled office consultations.
-The analysis of the influence of specific cultural characteristics or aspects of organization of national health systems within the HATICE trial will result in important information for future development of international interventions.
-The data sharing platform developed within HATICE for analysis of the ongoing trial data can be applied by other studies. In addition, more prospective tools were developed, which allow for data set representation as well as data traceability which lead to richer data handling. These tools are generic and can be applied to other studies as well.
-The shift that HATICE has made from reactive, hospital-based care towards proactive, home-based services, well integrated with existing social and health care structures will yield important new insights in the opportunities, challenges and limits of this new internet-based approach, laying the ground for future (international) prevention or treatment strategies.
-The HATICE project will actively address health literacy to achieve patient empowerment, increase adherence, advocate personal health management for prevention and management of functional decline, both physical and cognitive, specifically in older people.

List of Websites:

Reported by

Academisch Medisch Centrum bij de Universiteit van Amsterdam