Hersenonderzoek.nl

This application is based on the Memorabel application (round 5) entitled “Brain Health Registry (as attached). A detailed projectplan including timelines, milestones and deliverables can be found in the appendix. Introduction For studies and trials in the field of dementia and other brain diseases, there is a major and increasing mismatch between the limited number of participants (both healthy volunteers and patients) and the high number of subjects needed. Recruiting participants for clinical trials is one of the major bottlenecks in research, resulting in prolonged trial duration and increase in costs (Fargo et al, Alzheimers. Dement 2016). To solve this crisis in recruitment, we aim to create a unique Dutch registry of both older healthy (at risk) individuals and patients by means of an online platform: Hersenonderzoek.nl. This platform will connect participants and researchers, and will facilitate efficient recruitment of participants for clinical trials and observational studies. Potential participants will follow a four-step procedure: 1) visit the hersenonderzoek.nl website; 2) sign up and fill in a (MDS; minimal dataset) questionnaire; 3) stay engaged with the community (newsletters, online tests, meetings etc.); 4) get invited to participate in brain research studies and clinical trials. For studies recruiting via Hersenonderzoek.nl, we prescreen and select participants based on their provided information from the MDS questionnaire. After, participants indicate their interest to participate in this study via email. In this way, the recruitment process for investigators will be quicker and more effective with lower expected prescreen failures. Project plan WP 1. Database Back-end Software as a Service (SaaS solution) for data collection and storage. The software is provided by the University of San Francisco (founders of brainhealthregistry.com with >50.000 participants) and will be customized for Dutch purposes. Special attention is given to privacy and data protection according to Dutch and European data protection regulation (E.g. Dutch WBP, GDPR, etc.) and VUmc ethical and privacy standards. WP 2. Website The website www.hersenonderzoek.nl provides practical information on registration and recruiting studies, as well as informative and interactive content that will be developed in WP3. The website also functions as the entrance for the secured participant portal to fill in questionnaires, perform online cognitive tests and provide (personal) information. The website is build and will be further developed with Kaliber, who are experts at ICT solutions and user interaction. WP3: Participants The community manager will set up and implement a content strategy for recruitment of new participants and long-term consumer engagement. This includes informative and interactive content on our website, Facebook page, email, newsletters, organizing events and exposure in media. Content and exposure will be created in collaboration with Hersenstichting, Alzheimer Nederland and research projects focusing on brain health information (Euro-SCD and In-Mindd (JPND) projects). Our content marketing strategy is developed in collaboration with the award-winning company Yune. WP4. Investigator & studies First ‘use case’ dementia studies will test the screening and recruitment process, to set up a standardized procedure for future collaboration with researchers throughout the Netherlands. In addition, this platform will also recruit participants for other brain research studies and clinical trials throughout the Netherlands. The platform will be promoted through several professional research networks (including ZonMw, Hersenstichting and Alzheimer Nederland). Researchers’ requests for specific participants will be matched with the participant database. In addition, prescreening measures (MDS) will undergo continuous evaluation for optimal fit with current studies. WP5. Project & platform management Project governance including daily management, advisory and supervision. In addition, a business model will be developed that will safeguard the continuation of the project in the future, so that the registry will become sustainable and functioning as a catalyst for future research (e.g. Memorabel) studies. First results Phase 1, Sept 21, 2016 - Sept 20, 2017: Pilot registry named ‘Amsterdam Hersenonderzoek Register’ , recruited 500 (spontaneous) registrants and 3 studies for which in total n=83 participants were recruited in studies. Phase 2, from Sept 21, 2017 onwards: Official launch of Hersenonderzoek.nl at the 50Plus fair (Jaarbeurs Utrecht), with currently >8000 participants and 5 studies are currently recruiting. The great success of the pilot (Fase 1) and national launch (Fase 2) endorses our confidence in the feasibility of this project.