The project has been divided into 7 workpackages:
WP2: Development of a shared data platform
A shared data platform was developed for analysis of data from the ongoing trials.
HATICE created a security-protected area for HATICE partners to exchange and standardize data for analysis
The data of the ongoing trials are anonymised and uploaded for pooled analysis (WP3).
WP3: Ongoing trials evaluation
To determine the optimal settings for the new trial, HATICE assessed the effects of study setting, intervention content and delivery on the efficacy of each type of intervention and determined the efficacy of preventive interventions in ongoing trials on metabolic and life-style endpoints.
In addition, HATICE determined factors associated with participation to trials and evaluated adherence to the interventions of the ongoing trials.
HATICE identified barriers to participation in prevention trials to improve participation to the new trial and reduce selection bias.
WP4: Design of generic intervention
The evaluation of ongoing trials (WP3) is integrated with local and national guidelines of the countries involved in HATICE
Based on the evaluation in WP3, HATICE designed a generic intervention strategy that is applicable under the different health care systems of the countries involved in HATICE. To ensure applicability to virtually all EU countries, this is a generic intervention to which minor adaptations can be made.
In addition, the study protocol for the RCT in WP6 was written.
WP5: Internet intervention platform
Development and implementation
A user friendly, intuitive and interactive internet-platform was developed to optimise management of elderly patients with multiple cardiovascular diseases and risk factors.
The platform facilitates the multi-component interventions and improves adherence of the patients to the interventions.
The platform is implemented in three counties & languages.
WP6: Randomised controlled trial
Internet-based multi-component intervention
The HATICE trial recruited 2725 older people (>=65 years) at increased risk of cardiovascular disease. Participants randomized to the intervention group have access to an interactive internet platform, stimulating self-management of vascular risk factors, with remote support by a coach. Participants in the control group have access to a static internet platform with basic health information. We will assess the impact of the intervention on the cardiovascular risk profile and the risk of cardiovascular disease and cognitive decline. In September 2016, the last of in total 2725 participants was recruited for the HATICE trial. Baseline data collection was very complete with less than 1% missing values.
The trial is progressing as planned and adherence to the intervention is relatively high. The assessments will be finished in December 2017 and the results will be published in a peer reviewed international journal.