Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline
Susanne Röhr, Andrea Zülke, Melanie Luppa, Christian Brettschneider, Marina Weißenborn, Flora Kühne, Isabel Zöllinger, Franziska-Antonia Zora Samos, Alexander Bauer, Juliane Döhring, Kerstin Krebs-Hein, Anke Oey, David Czock, Thomas Frese, Jochen Gensichen, Walter E. Haefeli, Wolfgang Hoffmann, Hanna Kaduszkiewicz, Hans‐Helmut König, Jochen René Thyrian, Birgitt Wiese, Steffi G. Riedel‐Heller
Abstract
Targeting dementia prevention, first trials addressing multiple modifiable risk factors showed promising results in at-risk populations. In Germany, AgeWell.de is the first large-scale initiative investigating the effectiveness of a multi-component lifestyle intervention against cognitive decline. We aimed to investigate the recruitment process and baseline characteristics of the AgeWell.de participants to gain an understanding of the at-risk population and who engages in the intervention. General practitioners across five study sites recruited participants (aged 60-77 years, Cardiovascular Risk Factors, Aging, and Incidence of Dementia/CAIDE dementia risk score ≥ 9). Structured face-to-face interviews were conducted with eligible participants, including neuropsychological assessments. We analyzed group differences between (1) eligible vs. non-eligible participants, (2) participants vs. non-participants, and (3) between intervention groups. Of 1176 eligible participants, 146 (12.5%) dropped out before baseline; the study population was thus 1030 individuals. Non-participants did not differ from participants in key sociodemographic factors and dementia risk. Study participants were M = 69.0 (SD = 4.9) years old, and 52.1% were women. The average Montreal Cognitive Assessment/MoCA score was 24.5 (SD = 3.1), indicating a rather mildly cognitively impaired study population; however, 39.4% scored ≥ 26, thus being cognitively unimpaired. The bandwidth of cognitive states bears the interesting potential for differential trial outcome analyses. However, trial conduction is impacted by the COVID-19 pandemic, requiring adjustments to the study protocol with yet unclear methodological consequences.