COVID-19 and geriatric clinical trials research

Rhodus, Elizabeth K.; Bardach, Shoshana H.; Abner, Erin L.; Gibson, Allison; Jicha, Gregory A.

doi:10.1007/s40520-020-01705-x

Cited by 8 publications

(4 citation statements)

References 4 publications

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“…The planned sample size was three times higher than the present, but was not achieve due to the time limit and restriction during COVID. Further challenges of our experimental study are Covid 19 that commonly researchers have faced includes impact on safety and engagement also in terms of clinical trial operation, particularly involving vulnerable group such as older adults (42).…”

Section: Discussionmentioning

confidence: 99%

Multidomain intervention for reversal of cognitive frailty, towards a personalised approach (AGELESS Trial): Recruitment and baseline characteristics of participants

Ibrahim,

Singh,

Ludin

et al. 2023

Preprint

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Introduction: Reversal of cognitive frailty through a multidomain intervention is desirable to prevent dementia. AGELESS Trial was conducted with the aim to determine the effectiveness of a comprehensive, multidomain intervention on older adults with cognitive frailty (CF). However, conducting a clinical trial particularly during or post the Covid-19 pandemic posed unique challenges. Therefore, this study focuses on describing the recruitment process and baseline characteristics of the participants and adherence at one year of the trial. Methods: Community dwelling older adults, aged 60 years old and above were screened for cognitive and physical impairment using Clinical Dementia Rating and FRIED criteria respectively. Parallel randomised controlled trial was conducted comparing multidomain module (five modules: vascular management, diet, physical exercise, cognitive and psychosocial) with usual care for 24 months. Results: A total of 957 older adults from two locations, ie. urban (n=764) and rural (n=193) areas were screened and 38.9% had CF and eligible to participate. Those with CF had lower years of education, and cognitive status as assessed using mini mental state examination (MMSE) (p<0.05 for both parameters). Among those from urban areas, only 13.87%(n=106) agreed to participate, particularly those with multimorbidity, with a higher physical activity level and walking speed (p<0.05 for all parameters). At baseline, mean age of participants was 68.1±5.6 years, education years was 8.3 ± 3.9 years, body mass index (BMI) was 27.0± 4.8 kg/m2 and MMSE was 22.7± 4.0. Generally, there were no significant difference between intervention and control groups for main outcomes, except those in intervention group had a higher BMI, mid upper arm circumference and waist circumference (p<0.05 for all parameters). Overall adherence towards intervention at one year was 52.8 %, ranging from 60% to 91% for each of the modules. In conclusion, only one third of those who were eligible from urban area for this trial agreed to participate, particularly among those with multimorbidity, higher physical activity level and walking. Understanding factors that influence recruitment and participation is crucial in personalising the trial to the targeted group and interpreting the data within the context of the study population.

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Section: Discussionmentioning

confidence: 99%

Multidomain intervention for reversal of cognitive frailty, towards a personalised approach (AGELESS Trial): Recruitment and baseline characteristics of participants

Ibrahim,

Singh,

Ludin

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…In addition, after the relevant time period for accepting the pandemic declaration in clinical sites [ 27 ], the number of studies funded by both the industry and government increased in the postpandemic era compared to the prepandemic period. To sustain clinical trials, a stable funding source should be supported [ 28 ]; however, most resources have been directed to combat the COVID-19 crisis [ 29 ]. The current study findings indicate that funding for oncology trials by industries might be associated with the increased launch of new cancer trials during the pandemic [ 16 ], which explains their ongoing efforts to support and conduct oncology trials, as the industry hopes to proactively overcome the COVID lockdown situation [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

Impact of COVID-19 Pandemic Declaration on New Oncology Trial Commencements: An Interrupted Time Series with Segmented Regression Analysis

2022

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This study aimed to assess the trend in oncology trial commencements registered on ClinicalTrials.gov and to evaluate the contributing factors by comparing the trends in the pre- and post-COVID-19 pandemic era. The ClinicalTrials.gov database was searched to identify oncology study trials starting from 1 January 2018 to 28 February 2021. Data on the variables of start/complete date, phase, status, funding source, center, country and study type were extracted. According to the time point of the COVID-19 pandemic declaration by the World Health Organization (WHO), March 2020, we analyzed the extracted data, including interrupted time series (ITS) analysis and multivariable regression analysis. We identified 18,561 new oncology trials during the study period. A total of 5678 oncology trials in the prepandemic period and 6134 in the postpandemic period were included in the comparative analysis. The year 2020 had the most newly launched trials (32.3%), and the majority of trials were planned to be conducted for longer than two years (70.3%). The results of ITS show the trend in the commencement of oncology trials was significantly increased after the pandemic declaration (coefficient = 27.99; 95% CI = 19.27 to 36.71). Drug intervention trials were the largest contributor to the increased trial number compared to different interventions, such as trials of devices or procedures (OR = 1.14; 95% CI = 1.03 to 1.26, OR = 1.09; 95% CI = 0.91 to 1.29, and OR = 1.12; 95% CI = 0.96 to 1.31, respectively), whereas the United Kingdom was the highest contributor to the number of decreased trials (OR = 0.67; 95% CI = 0.51 to 0.89 p = 0.01) in the postpandemic era. The interruption in oncology trial initiation was diminished shortly after the COVID-19 pandemic declaration, which was influenced by several factors, such as interventions or national responses. Based on the current outcomes, appropriate strategies for developing oncology trials can be planned to mitigate the impact of future crises on oncology trials.

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“…The former COVID-19 crisis has had a significant impact on clinical trials focused on interventions or treatments for age-related conditions [24]. Delays in these trials occured as various factors were affected.…”

Section: Implications Of the Crisis On Research And Healthcarementioning

confidence: 99%

Aging and Geriatric Care: A Global Imperative Towards Universal Health Coverage

Singh,

Yadav,

Doskaliuk

2023

AAEE

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The global population of older people is projected to surpass the number of children under 5 years old and adolescents by 2050, with developing countries housing the majority of older individuals. This demographic shift necessitates adjustments in global health systems to cater to the increasing demand for age-appropriate care. Gerontology, as an interdisciplinary field, encompasses the study of biological, social, and medical aspects of aging. Anti-aging, a distinct discipline, focuses on understanding and combatting age-related ailments. This review provides insights into the distinctive aspects of anti-aging research, highlights current priority issues in health promotion and anti-aging measures, and explores implications of crises on aging research and healthcare. Furthermore, it emphasizes the need for collaboration among interdisciplinary research networks, integration of science and technology, and the involvement of key stakeholders to ensure universal health coverage. Future research should address the multidimensional aspects of healthy aging, reflect research priorities and preferences of older individuals, and promote health equity. This collective effort will contribute to the development of innovative solutions and facilitate cross-learning among countries to enhance the well-being of aging populations globally.

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COVID-19 and geriatric clinical trials research

Cited by 8 publications

References 4 publications

Multidomain intervention for reversal of cognitive frailty, towards a personalised approach (AGELESS Trial): Recruitment and baseline characteristics of participants

Multidomain intervention for reversal of cognitive frailty, towards a personalised approach (AGELESS Trial): Recruitment and baseline characteristics of participants

Impact of COVID-19 Pandemic Declaration on New Oncology Trial Commencements: An Interrupted Time Series with Segmented Regression Analysis

Aging and Geriatric Care: A Global Imperative Towards Universal Health Coverage

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