The impact of the COVID-19 pandemic on public health is staggering; more than one hundred million cases and two million deaths worldwide. In response, most countries and local governments have taken substantial measures — such as travel restrictions and physical distancing — to keep their citizens safe. Both the pandemic and related protective measures pose challenges for ongoing clinical research studies seeking to treat and prevent the world's greatest public health emergencies including COVID-19, but also Alzheimer’s disease and other dementia.
In a new paper from the World-Wide FINGERS (WW-FINGERS) network in Alzheimer's & Dementia: Translational Research and Clinical Interventions, first author Susanne Röhr, Atlantic Fellow and clinical psychologist at the University of Leipzig, Germany, and colleagues provide timely guidance on the design and management of clinical research during COVID-19 — specifically on the conduct of lifestyle-based risk reduction studies in people at risk for cognitive decline and dementia.
The article describes the COVID-19-related experiences of three trials - each at a different stage of the study process - conducted in conjunction with the World-Wide FINGERS, the first global network of lifestyle-based multidomain trials for dementia risk reduction and prevention, which includes over 30 countries.
- J-MINT: Japan-multimodal intervention trial for prevention of dementia — mainly in the recruitment process (~December, 2020) and intervention delivery.
- U.S. POINTER: U.S. study to protect brain health through a lifestyle intervention to reduce risk — recruitment process and intervention delivery.
- German AgeWell.de study — intervention adherence and post-intervention follow-up.
“The COVID-19 pandemic has profoundly altered the landscape for the design and conduct of clinical trials of multidomain lifestyle interventions. This is especially true in studies focused on cognition, Alzheimer’s and other dementia, where the study population has some of the greatest health risks,” said Röhr.
“With this collaborative publication, we bring together and discuss our experiences of the challenges we’ve faced, and continue to face, and how we’ve responded to them. By sharing our collective knowledge about the lessons learned so far, we can provide real-world, evidence-based recommendations to similar ongoing and prospective lifestyle intervention trials,” Röhr added.
In response to COVID-19, the WW-FINGERS network created a shared space for its members to discuss the challenges of research during the pandemic. They gathered international teams with expertise to address, almost in real-time, the challenges that cut across the research. This allows studies at earlier stages to adjust to these potential challenges, while more advanced studies will still be able to access expertise to adapt to their specific circumstances.
Lifestyle intervention research may be particularly susceptible to disruption from the pandemic. Traditionally, lifestyle interventions focus on strong bonds through group and individual face-to-face sessions. Social isolation — which can result from physical distancing — can also challenge lifestyle interventions. Research studies focused on preventing cognitive decline often recruit individuals for whom COVID-19 poses greater risks due to their older age and greater burden of age-related noncommunicable diseases.
Each of the four WW-FINGERS studies adapted by altering designs and analysis plans — changing recruitment plans, timelines, and modes of delivery for interventions and assessments.
The paper “Impact of COVID-19 Pandemic on Statistical design and Analysis Plans for Multidomain Intervention Clinical Trials: Experience from World-Wide FINGERS,” has been published online in advance of hard-copy publication in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.
Authors
Susanne Röhr, PhD
Clinical Psychologist, Epidemiology & Public Health Researcher
