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WW‐FINGERS researchers describe how study protocols and processes have been adapted during the COVID-19 pandemic

Thursday 11 March 2021

The Finnish FINGER trial was among the first to show the cognitive benefit of multi-domain interventions including exercise, improved diet, social stimulation and management of lifestyle factors in older people at risk of developing dementia. World-Wide FINGERS (WW-FINGERS) is an interdisciplinary network that brings together several clinical studies and research groups evaluating preventive interventions targeting modifiable risk factors based on the FINGER model, including the US-POINTER, J-MINT and studies, three clinical trials in the US, Japan and Germany.

In a perspective article, published in the journal Alzheimer's & Dementia: Translational Research and Clinical Interventions, Dr. Susanne Rohr, Prof. Mark Espeland and colleagues in the WW-FINGERS study shared experiences on the design and management of clinical research during the COVID-19 pandemic. The article describes COVID-19-related experiences from US-POINTER, J-MINT and and alterations and adaptations made necessary by the pandemic in these clinical trials involving people at risk for cognitive decline and dementia.

For example, the Japanese 18-month multidomain intervention for dementia prevention trial called J-MINT has been affected by the pandemic mainly in the recruitment process. Compared to the schedule originally planned, the progress of the study has been delayed more than half a year. J-MINT investigators describe how face shields and/or masks and social distancing are used during exercise classes, while in Germany, participants are offered assessments in their homes as well as at study sites. While recruitment and baseline assessments were completed before the pandemic for the study, infection control measures and post‐intervention follow‐up assessments have been impacted.

In addition, authors provided recommendations for future behavioural intervention trials and emphasised the importance of ensuring that study designs are sufficiently flexible to enable lifestyle interventions to be delivered in a physically distanced environment, with remote follow-up assessments as required. The authors identify some statistical considerations, indicating that study designs may need to be adapted to preserve statistical power and facilitate statistical analyses.