The COPE Trial Innovation Project (TrIP) studies how more representative older patients can be included in clinical studies, by testing modern technology and novel methodology.
Elderly are systematically excluded from randomize controlled trials (RCTs) and it is questionable whether health care for older people is evidence-based. Repeating all RCTs in representative older populations is not feasible. New strategies to obtain large-scale clinical evidence in the elderly are warranted. New technologies (such as internet, smartphones and home measurements) and alternative study methodologies provide a promising opportunity.
Dementia causes a great burden on patient, caregivers and society and its incidence is expected to double over the next decades. Research in preventive strategies is hampered by the necessity for very large cohorts with long follow-up. In the long term we envisage use of new technologies and alternative study methodologies in scientific research in the elderly. An example of such a study is the "Preservation of Brain function in the Elderly (PROBE)" study. In PROBE, a large cohort of participants will monitor their health and behavior at home using sensors, smartphones and internet. Data will be transferred to a central digital infrastructure, which also allows for testing the effect of multiple medical and lifestyle related intervention on cognitive decline. In PROBE, the use of a regression discontinuity design allows for testing of multiple interventions simultaneously.
In the present project we aim to develop a digital research infrastructure and deliver proof-of-principle of technological and methodological components for the future PROBE study.
Initially, we target blood pressure, as it is an amendable risk factor for dementia and can easily be measured at home. Offspring of dementia patients are at increased risk for both high blood pressure and dementia and therefore most likely to be highly motivated to comply with preventive strategies.
The overall aim of the current proposal is worked out in four work packages (WPs). Partners in the project are Maastricht University, Radboud University Nijmegen, Erasmus Medical Center Rotterdam, Amsterdam Medical Center, Leiden University Medical Center, TNO, NIVEL. COPE acts as the coordninator of the study.