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 and Steffi G. Riedel-Heller
Additional contact information
Susanne Röhr: Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany
Andrea Zülke: Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany
Melanie Luppa: Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany
Christian Brettschneider: Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany
Marina Weißenborn: Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, 69120 Heidelberg, Germany
Flora Kühne: Institute of General Practice/Family Medicine, University Hospital of LMU Munich, 80336 Munich, Germany
Isabel Zöllinger: Institute of General Practice/Family Medicine, University Hospital of LMU Munich, 80336 Munich, Germany
Franziska-Antonia Zora Samos: Institute of General Practice and Family Medicine, Martin-Luther-University Halle-Wittenberg, 06112 Halle (Saale), Germany
Alexander Bauer: Institute of General Practice and Family Medicine, Martin-Luther-University Halle-Wittenberg, 06112 Halle (Saale), Germany
Juliane Döhring: Institute of General Practice, University of Kiel, 24105 Kiel, Germany
Kerstin Krebs-Hein: Institute of General Practice, University of Kiel, 24105 Kiel, Germany
Anke Oey: Institute for General Practice, Work Group Medical Statistics and IT-Infrastructure, Hannover Medical School, 30625 Hannover, Germany
David Czock: Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, 69120 Heidelberg, Germany
Thomas Frese: Institute of General Practice and Family Medicine, Martin-Luther-University Halle-Wittenberg, 06112 Halle (Saale), Germany
Jochen Gensichen: Institute of General Practice/Family Medicine, University Hospital of LMU Munich, 80336 Munich, Germany
Walter E. Haefeli: Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, 69120 Heidelberg, Germany
Wolfgang Hoffmann: Institute for Community Medicine, University Medicine Greifswald, 17489 Greifswald, Germany
Hanna Kaduszkiewicz: Institute of General Practice, University of Kiel, 24105 Kiel, Germany
Hans-Helmut König: Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany
Jochen René Thyrian: Institute for Community Medicine, University Medicine Greifswald, 17489 Greifswald, Germany
Birgitt Wiese: Institute for General Practice, Work Group Medical Statistics and IT-Infrastructure, Hannover Medical School, 30625 Hannover, Germany
Steffi G. Riedel-Heller: Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany

IJERPH, 2021, vol. 18, issue 2, 1-15

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.

Keywords: AgeWell.de; dementia; cognitive function; prevention; intervention; lifestyle; trial; RCT; cluster-randomized controlled trial; primary care; general practitioner (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
References: View references in EconPapers View complete reference list from CitEc
Citations: View citations in EconPapers (1)

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