Adapting Alzheimer Disease and Related Dementias Clinical Research Evaluations in the Age of COVID-19

Loizos, Maria; Neugroschl, Judith; Zhu, Carolyn W.; Li, Clara; Sewell, Margaret; Kinsella, Michael; Aloysi, Amy; Grossman, Hillel; Schimming, Corbett; Martin, Jane; Sano, Mary

doi:10.1097/wad.0000000000000455

Cited by 3 publications

(3 citation statements)

References 15 publications

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“…Underlying health conditions, including Alzheimer’s disease (AD) and Alzheimer’s disease related dementias (ADRD), added additional concerns for morbidity and mortality ( 4 , 5 ). Thus, clinical trial research for ADRD was markedly impeded during 2020 and 2021 ( 6 ). Lasting implications of COVID-19 for clinical trials in ADRD research have yet to be fully identified ( 7 ).…”

Section: Introductionmentioning

confidence: 99%

Alzheimer’s Disease Clinical Trial Research Adaptation Following COVID-19 Pandemic Onset: National Sample of Alzheimer’s Clinical Trial Consortium Sites

et al. 2022

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Background The COVID-19 pandemic created challenges in clinical research operations that required immediate and lasting changes. Ojbectives The purpose of this study was to explore adaptations to clinical trial research due to COVID-19 and develop a theoretical framework of emergent strategies related to pandemic mitigation in a national network of Alzheimer’s disease clinical trial sites. Design This qualitative study used a grounded theory approach including semi-structured interviews, constant comparative methods, and multi-level, iterative coding. Participants Twenty-six member sites of the Alzheimer’s Clinical Trial Consortium participated with a total of 49 participants. Results Findings demonstrate processes of adaptation following COVID-19 onset including establishing safety as priority, focus on scientific preservation, accommodations (creating policies, leadership mindset, maintaining operations, and determining research procedures), and evaluation of changes throughout the course of the pandemic. Communication and maintaining integrity were vital throughout these processes. Conclusion Processes of accommodation among clinical research sites during the pandemic provide critical insights and direction for future clinical trials development and emergent methods in Alzheimer’s disease and other therapeutic areas.

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Section: Introductionmentioning

confidence: 99%

Alzheimer’s Disease Clinical Trial Research Adaptation Following COVID-19 Pandemic Onset: National Sample of Alzheimer’s Clinical Trial Consortium Sites

et al. 2022

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“…The ISMMS ADRC’s conversion to phone evaluations allowed a rapid transition to collecting remote data and maintaining contact to support retention in our longitudinal research. The ADRC’s process of in-person to telephone modification has been previously published 2 . As the pandemic proceeded, a small number of participants spontaneously requested a video conference option, and beginning in late June 2020, we accommodated these requests.…”

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confidence: 99%

“…The ADRC's process of in-person to telephone modification has been previously published. 2 As the pandemic proceeded, a small number of participants spontaneously requested a video conference option, and beginning in late June 2020, we accommodated these requests.…”

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confidence: 99%

Lessons From the Coronavirus Disease Experience

Sewell,

Neugroschl,

Zhu

et al. 2024

Alzheimer Disease &Amp; Associated Disorders

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Objective: In New York City in 2020 the pandemic shut down in-person research. Icahn School of Medicine’s Alzheimer’s Disease Research Center transitioned longitudinal evaluations from in-person to telephone to enhance equity of access. We assessed diverse research participants’ and clinical research coordinators’ (CRC) satisfaction with remote evaluation and examined sociodemographic, cognitive, and behavioral factors that might impact satisfaction. Methods: Data collected: 241 participants with Clinical Dementia Rating (CDR) = 0/0.5 (3/2020 to 6/2021). A Telehealth Satisfaction Questionnaire for CRCs and participants was administered at the end of remote evaluations. We compared Telehealth Satisfaction Questionnaire items by CDR and Geriatric Depression Scale. Results: Participants’ mean age was 78.4, 61.4% were females, 16.2% were Hispanic, 17.1% Asian, 15.8% were non-Hispanic black, and 72.6% CDR = 0. Participant satisfaction was high [14.1 ± 1.4 (out of 15)] but was lower among those with depression. CRC satisfaction was high [16.9 ± 1.8 (out of 18)] but was lower concerning the ability to explain the test battery and interact with participants with CDR = 0.5. Conclusion: Telephone research assessments provide flexibility in a hybrid model. They offer equitable access to research participation for those who do not use computer technology and may promote the retention of diverse elderly research participants.

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Feasibility, validity, and normative data for the remote Uniform Data Set neuropsychological battery at the University of Pennsylvania Alzheimer's Disease Research Center

Hackett,

Shi,

Schankel

et al. 2024

Alz & Dem Diag Ass & Dis Mo

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INTRODUCTIONWe investigated the feasibility and validity of the remotely‐administered neuropsychological battery from the National Alzheimer's Coordinating Center Uniform Data Set (UDS T‐Cog).METHODSTwo hundred twenty Penn Alzheimer's Disease Research Center participants with unimpaired cognition, mild cognitive impairment, and dementia completed the T‐Cog during their annual UDS evaluation. We assessed administration feasibility and diagnostic group differences cross‐sectionally across telephone versus videoconference modalities, and compared T‐Cog to prior in‐person UDS scores longitudinally.RESULTSAdministration time averaged 54 min and 79% of participants who initiated a T‐Cog completed all 12 subtests; completion time and rates differed by diagnostic group but not by modality. Performance varied expectedly across groups with moderate to strong associations between most T‐Cog measures and in‐person correlates, although select subtests demonstrated lower comparability.DISCUSSIONThe T‐Cog is feasibly administered and shows preliminary validity in a cognitively heterogeneous cohort. Normative data from this cohort should be expanded to more diverse populations to enhance utility and generalizability.Highlights This study examined the feasibility and validity of the remote Uniform Data Set (also known as the T‐Cog) and contributes key normative data for widespread use. A remote neuropsychological battery was feasibly administered with high overall engagement and completion rates, adequate reliability compared to in‐person testing, and evidence of validity across diagnostic groups. Typical barriers to administration included hearing impairment, technology issues, and distractions; hearing difficulties were particularly common among cognitively impaired groups. Certain tests were less closely related to their in‐person correlates and should be used with caution.

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Adapting Alzheimer Disease and Related Dementias Clinical Research Evaluations in the Age of COVID-19

Cited by 3 publications

References 15 publications

Alzheimer’s Disease Clinical Trial Research Adaptation Following COVID-19 Pandemic Onset: National Sample of Alzheimer’s Clinical Trial Consortium Sites

Alzheimer’s Disease Clinical Trial Research Adaptation Following COVID-19 Pandemic Onset: National Sample of Alzheimer’s Clinical Trial Consortium Sites

Lessons From the Coronavirus Disease Experience

Feasibility, validity, and normative data for the remote Uniform Data Set neuropsychological battery at the University of Pennsylvania Alzheimer's Disease Research Center

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