Grassroots Approaches To Community-Based Representative Recruitment In Multidomain Trials

Abstract U.S. POINTER is a randomized, controlled, multi-domain clinical trial to slow the progression of cognitive decline within the American population via tailored and culturally-appropriate healthy lifestyle interventions. For findings to be broadly relevant across the American population, incorporating an inclusive and robust recruitment effort has been essential to form a diverse and properly representative participant cohort. As such, the trial’s inclusive enrollment goal is 30% from traditionally underrepresented communities that include those at elevated risk for Alzheimer’s disease and related disorders. To accomplish this goal, U.S. POINTER developed and deployed a grassroots recruitment strategy in partnership with outreach specialists at each site that includes a mix of evidence-based and innovative community engagement approaches. While the COVID-19 pandemic continues to present unique challenges for recruitment, our team has been able to strategize ways to continue working within the community to support trial recruitment. An overview of these methods will be presented.


INFUSING REPRESENTATIVENESS AND CULTIVATING HARMONIZATION IN ALZHEIMER'S TRIALS: WORLD WIDE FINGERS
Chair: Rema Raman Discussant: Neelum Aggarwal World Wide Fingers is a network involving over 30 countries organized to conduct randomized controlled clinical trials to slow the progression of cognitive decline and reduce dementia risks.Trials are designed to parallel the successful Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial of a multidomain lifestyle intervention featuring increased physical activity, improved diet, cognitive training, and metabolic risk factor monitoring.While FINGER found that its intervention significantly benefited cognitive function, it is not clear whether this approach might be successfully tailored to other cultures and environments to yield similar results.This is the goal of World Wide FINGERS.It infuses representativeness by enrolling cohorts that reflect the communities in which it is conducted.For findings across the many trials to be integrated, it is necessary for protocols to be harmonized as much as possible.The COVID-19 pandemic presents special challenges towards harmonization as its disruptions of trial protocols and conduct vary among countries and over time.This symposium is organized to provide the scientific background and framework for the World Wide FINGERS.Novel grassroots efforts towards enrolling representative cohorts in the US will be described.Plans for harmonization and federated data analyses spanning international boundaries and regulations will be outlined.Integrated approaches to challenges of COVID-19 pandemic across trials will be presented.The conclusion of this session will be a discussion of how World Wide FINGERS may serve as a model for collaborative approaches to identify effective, translatable approaches to reduce risks for Alzheimer's disease.

THE SCIENCE BEHIND MULTIDOMAIN INTERVENTIONS TO SLOW COGNITIVE DECLINE Francesca Mangialasche, Karolinska Institutet, Stockholm, Sweden
The spotlight on interventions to protect brain health and prevent Alzheimer's disease (AD) has recently widened to include risk modification.In the last 20 years, evidence continues to build to support cognition-enhancing effects of individual lifestyle components, which include, among others, physical exercise, diet, cognitive training, and cardiovascular risk management.A recent evolution of lifestyle trials is to combine these components as part of intervention delivery.The potential benefit of this approach on cognition in older adults, first showcased in the FINGER trial, is now under investigation by multiple groups across the nation and the globe.The multidomain approach offers important opportunities to boost lifestyle intervention 'dose', to examine inter-component synergistic effects, and for intervention tailoring to meet specific needs and limitations.Harmonization and data-sharing will be essential to meaningfully address the question of whether multidomain lifestyle modification can indeed be 'medicine' to protect brain health and reduce AD risk.

WORLD-WIDE FINGERS: AN INTERNATIONAL NETWORK OF LINKED MULTIDOMAIN TRIALS
Francesca Mangialasche, 1 Alina Solomon, 2 Tiia Ngandu, 3 and Miia Kivipelto, 2 1. Division of Clinical Geriatrics,Stockholm,Stockholms Lan,Sweden,2. Karolinska Institutet,Stockholm,Stockholms Lan,Sweden,3. Finnish Institute for Health and Wefare,Public Health Promotoin Unit,Uusimaa,Finland Risk reduction and prevention of dementia in older adults is a growing research area.In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER randomized controlled trial) a 2-year multidomain intervention -dietary counseling, exercise, cognitive training, vascular and metabolic risk monitoring-improved cognition in older adults from the general population who had increased dementia risk.The intervention was associated also with improvement of other clinical outcomes (e.g., multimorbidity, functional status).The FINGER model is being adapted and tested in different populations and settings through the World-Wide FINGERS, the first global network of multidomain prevention trials, including over thirty countries.The network goal is to identify effective and feasible solution for dementia risk reduction across the spectrum of cognitive decline -from at-risk asymptomatic states to early-symptomatic stages.Through the World-Wide FINGERS-SARS-CoV-2 initiative, the network aims to assess the effects of the COVID-19 pandemic in older adults.

GRASSROOTS APPROACHES TO COMMUNITY-BASED REPRESENTATIVE RECRUITMENT IN MULTIDOMAIN TRIALS
Marcus Hill, Division of Gerontology and Geriatric Medicine, Winston-Salem, North Carolina, United States U.S. POINTER is a randomized, controlled, multidomain clinical trial to slow the progression of cognitive decline within the American population via tailored and culturally-appropriate healthy lifestyle interventions.For findings to be broadly relevant across the American population, incorporating an inclusive and robust recruitment effort has been essential to form a diverse and properly representative participant cohort.As such, the trial's inclusive enrollment goal is 30% from traditionally underrepresented communities that include those at elevated risk for Alzheimer's disease and related disorders.To accomplish this goal, U.S. POINTER developed and deployed a grassroots recruitment strategy in partnership with outreach specialists at each site that includes a mix of evidence-based and innovative community engagement approaches.While the COVID-19 pandemic continues to present unique challenges for recruitment, our team has been able to strategize ways to continue working within the community to support trial recruitment.An overview of these methods will be presented.

HARMONIZING DATA COLLECTION AND ANALYSIS IN WORLDWIDE FINGERS TRIALS Markku Peltonen, Population Health Unit, Helsinki, Uusimaa, Finland
One of the goals of the World-Wide FINGERS (WW-FINGERS): A Global Approach to Dementia Prevention network is to prospectively facilitate data sharing and joint analyses across clinical trials on prevention of cognitive impairment and dementia.The aim with prospectively harmonizing studies in different countries and settings regarding interventions, outcomes, measurements, data collection, and establishing best practices for responsible data sharing and access to data for remote joint analyses, is to increase the use of clinical trial data.By utilizing federated database system which connects multiple autonomous, decentralized databases and enables data-analyses to be conducted without individual level data being transferred, could be a feasible and acceptable technical solution for countries around the world, given wide variations in data protection and sharing regulations.Ultimately, prospectively harmonizing clinical studies and establishing a culture of harmonization and sharing, will promote international joint initiatives to identify globally implementable and effective preventive strategies.

MAINTAINING INTEGRITY OF WORLDWIDE FINGER CLINICAL TRIALS DURING THE COVID-19 PANDEMIC Susanne Roehr, Institute of Social Medicine, Occupational Health and Public Health (ISAP), Leipzig, Sachsen, Germany
The COVID-19 pandemic presents challenges to the conduct of randomized clinical trials of lifestyle interventions.World-Wide FINGERS international network convened a forum for researchers to discuss statistical design and analysis issues they faced during the pandemic.We report experiences of three trials that, at various stages of conduct, altered designs and analysis plans to navigate these issues.We provide recommendations for future trials to consider as they develop and launch behavioral intervention trials.The pandemic led researchers to change recruitment plans, interrupt timelines for assessments and intervention delivery, and move to remote intervention and assessments protocols.The necessity of these changes add emphasis to the importance, in study design and analysis, of intention to treat approaches, flexibility, within site stratification, interim power projections, and sensitivity analyses.Robust approaches to study design and analysis are critical to negotiate issues related to the intervention.

INTEGRATING HUMANITIES AND ARTS INTO GERONTOLOGY AND GERIATRICS CURRICULA
Chair: Desmond O'Neill Co-Chair: Dana Bradley Discussant: James Powers Humanities, Arts and Cultural Gerontology (HACG) has been an integral element of GSA for over 4 decades, and is included as a notable feature of AGHE guidelines on curricula for gerontology and geriatrics.However, as with many interdisciplinary areas, the degree to which HACG has been successfully inserted into curricula, the extent to which this has involved engagement of faculty in arts and humanities, and the facilitators and barriers of such deeper joint working are unknown.The HACG Advisory Panel and AGHE would like to convene a round-table/symposium at the 2021 Phoenix GSA Meeting to consider the range of experiences of educators of programs in gerontology/geriatrics, from those who can relate success stories in integrating HACG into their curricula, to those who can give insights into challenges and opportunities in attempts to develop such elements in their curricula.Co-convened by Des O'Neill, Chair HACG AP and Dana Burr Bradley AGHE Program Chair, we invite lively discussion which we consider will aid in the development of a road map towards substantive and rewarding initiatives in incorporating scholarship and education in HACG in gerontology and geriatrics educational program

A DECADE OF TEACHING THE COURSE AGING & THE ARTS: REFLECTING ON OPPORTUNITIES AND CHALLENGES Jacqueline Eaton, University of Utah, University of Utah, Utah, United States
In 2010, the University of Utah Gerontology Interdisciplinary Program first offered GERON 5240/6240: Aging and the Arts.This course was developed to enrich program curricula by addressing a gap in content specific to the arts and humanities.The purpose of this presentation is to focus on identifying the opportunities and challenges experienced teaching this course over the past decade.Opportunities will highlight competency mapping, internal and external partnerships, the benefits of bridging disciplines, and innovation in teaching and problem-solving.Challenges experienced include addressing various needs (online learning, undergraduate and graduate levels, multiple disciplines), tuition differentials, and varying levels of enrollment.A stand-alone course is one method of increasing humanities, arts, and cultural gerontology within curricula.It has the potential of enhancing student interest in gerontology while also demonstrating how the arts and humanities can improve work across disciplines.