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Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline

Author

Listed:
  • Susanne Röhr

    (Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany
    Global Brain Health Institute (GBHI), Trinity College Dublin, D02 PN40 Dublin, Ireland
    These two authors contributed equally.)

  • Andrea Zülke

    (Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, 04103 Leipzig, Germany
    These two authors contributed equally.)

  • 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
    German Center for Neurodegenerative Diseases (DZNE), Site Rostock/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
    German Center for Neurodegenerative Diseases (DZNE), Site Rostock/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)

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.

Suggested Citation

  • Susanne Röhr & Andrea Zülke & Melanie Luppa & Christian Brettschneider & Marina Weißenborn & Flora Kühne & Isabel Zöllinger & Franziska-Antonia Zora Samos & Alexander Bauer & Juliane Döhring & Kerstin, 2021. "Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline," IJERPH, MDPI, vol. 18(2), pages 1-15, January.
    • Handle: RePEc:gam:jijerp:v:18:y:2021:i:2:p:408-:d:476016
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    References listed on IDEAS

    as
    1. Eileen M CrimminsPhD & Yasuhiko SaitoPhD & Jung Ki KimPhD & Yuan S ZhangMS & Isaac SassonPhD & Mark D HaywardPhD, 2018. "Educational Differences in the Prevalence of Dementia and Life Expectancy with Dementia: Changes from 2000 to 2010," The Journals of Gerontology: Series B, The Gerontological Society of America, vol. 73(suppl_1), pages 20-28.
    2. Tiia Ngandu & Jenni Lehtisalo & Esko Levälahti & Tiina Laatikainen & Jaana Lindström & Markku Peltonen & Alina Solomon & Satu Ahtiluoto & Riitta Antikainen & Tuomo Hänninen & Antti Jula & Francesca Ma, 2014. "Recruitment and Baseline Characteristics of Participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)—A Randomized Controlled Lifestyle Trial," IJERPH, MDPI, vol. 11(9), pages 1-16, September.
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    Cited by:

    1. Sina K. Gerhards & Melanie Luppa & Susanne Röhr & Alexander Pabst & Alexander Bauer & Thomas Frankhänel & Juliane Döhring & Catharina Escales & Isabel Renate Zöllinger & Anke Oey & Christian Brettschn, 2023. "Depression and Anxiety in Old Age during the COVID-19 Pandemic: A Comparative Study of Individuals at Cardiovascular Risk and the General Population," IJERPH, MDPI, vol. 20(4), pages 1-13, February.

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