Journal Articles
Permanent URI for this collectionhttps://mro.massey.ac.nz/handle/10179/7915
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Item Impact of the COVID-19 pandemic on statistical design and analysis plans for multidomain intervention clinical trials: Experience from World-Wide FINGERS(Wiley Periodicals Inc on behalf of Alzheimer's Association, 2021-03-11) Röhr S; Arai H; Mangialasche F; Matsumoto N; Peltonen M; Raman R; Riedel-Heller SG; Sakurai T; Snyder HM; Sugimoto T; Carrillo M; Kivipelto M; Espeland MA; World‐Wide FINGERS Study GroupIntroduction The coronavirus disease-19 (COVID-19) pandemic presents challenges to the conduct of randomized clinical trials of lifestyle interventions. Methods World-Wide FINGERS is an international network of clinical trials to assess the impact of multidomain lifestyle intervention on cognitive decline in at-risk adults. Individual trials are tailoring successful approaches from the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) to local cultures and environments. The network convened a forum for researchers to discuss statistical design and analysis issues they faced during the pandemic. We report on 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. Results The pandemic led researchers to change recruitment plans, interrupt timelines for assessments and intervention delivery, and move to remote intervention and assessment 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. Discussion Robust approaches to study design and analysis are critical to negotiate issues related to the intervention. The world-wide network of similarly oriented clinical trials will allow us to evaluate the effectiveness of responses to the pandemic across cultures, local environments, and phases of the pandemic.Item Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline(MDPI (Basel, Switzerland), 2021-01) Röhr S; Zülke A; Luppa M; Brettschneider C; Weißenborn M; Kühne F; Zöllinger I; Samos F-AZ; Bauer A; Döhring J; Krebs-Hein K; Oey A; Czock D; Frese T; Gensichen J; Haefeli WE; Hoffmann W; Kaduszkiewicz H; König H-H; Thyrian JR; Wiese B; Riedel-Heller SGTargeting 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.Item Changes in Social Network Size Are Associated With Cognitive Changes in the Oldest-Old(Frontiers Media S.A, 2020-05) Röhr S; Löbner M; Gühne U; Heser K; Kleineidam L; Pentzek M; Fuchs A; Eisele M; Kaduszkiewicz H; König H-H; Brettschneider C; Wiese B; Mamone S; Weyerer S; Werle J; Bickel H; Weeg D; Maier W; Scherer M; Wagner M; Riedel-Heller SGObjectives: Social isolation is increasing in aging societies and several studies have shown a relation with worse cognition in old age. However, less is known about the association in the oldest-old (85+); the group that is at highest risk for both social isolation and dementia. Methods: Analyses were based on follow-up 5 to 9 of the longitudinal German study on aging, cognition, and dementia in primary care patients (AgeCoDe) and the study on needs, health service use, costs, and health-related quality of life in a large sample of oldest-old primary care patients (AgeQualiDe), a multi-center population-based prospective cohort study. Measurements included the Lubben Social Network Scale (LSNS-6), with a score below 12 indicating social isolation, as well as the Mini-Mental Status Examination (MMSE) as an indicator of cognitive function. Results: Dementia-free study participants (n = 942) were M = 86.4 (SD = 3.0) years old at observation onset, 68.2% were women. One third (32.3%) of them were socially isolated. Adjusted linear hybrid mixed effects models revealed significantly lower cognitive function in individuals with smaller social networks (β = 0.5, 95% CI = 0.3–0.7, p < .001). Moreover, changes in an individual’s social network size were significantly associated with cognitive changes over time (β = 0.2, 95% CI = 0.1–0.4, p = .003), indicating worse cognitive function with shrinking social networks. Conclusion: Social isolation is highly prevalent among oldest-old individuals, being a risk factor for decreases in cognitive function. Consequently, it is important to maintain a socially active lifestyle into very old age. Likewise, this calls for effective ways to prevent social isolation.