The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience

Feinstein, Anthony; Amato, Maria Pia; Brichetto, Giampaolo; Chataway, Jeremy; Chiaravalloti, Nancy D.; Cutter, Gary; Dalgas, Ulrik; DeLuca, John; Farrell, Rachel; Feys, Peter; Filippi, Massimo; Freeman, Jennifer; Inglese, Matilde; Meza, Cecilia; Motl, Rob; Rocca, Maria; Sandroff, Brian M.; Salter, Amber

doi:10.1007/s00415-021-10881-3

Cited by 5 publications

(2 citation statements)

References 14 publications

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“…Of note, although the main reference has been recently published, 27 other papers have already been published based on data from the present study. [28][29][30][31][32] All procedures described below were standardized across sites via comprehensive in-person and remote training, a detailed study manual and quality control conducted on a case-by-case basis.…”

Section: Methodsmentioning

confidence: 99%

Prevalence and Associated Clinical Characteristics of Walking-Related Motor, Cognitive, and Fatigability in Progressive Multiple Sclerosis: Baseline Results From the CogEx Study

Ramari,

D’hooge,

Dalgas

et al. 2024

Neurorehabil Neural Repair

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Background: People with progressive multiple sclerosis (PMS) present motor (eg, walking) and cognitive impairments, and report fatigue. Fatigue encompasses fatigability which is objectively measured by the capacity to sustain a motor or cognitive task. Objective: To investigate the prevalence of walking and cognitive fatigability (CF) and the associated clinical characteristics in a large sample of PMS patients. Methods: PMS patients (25-65 years old) were included from 11 sites (Europe and North America), having cognitive impairment (1.28 standard deviation below normative data for the symbol digit modality test [SDMT]). Walking fatigability (WF) was assessed using the distance walk index (DWI) and CF using the SDMT (scores from the last 30 seconds compared to the first 30 seconds). Additional measures were: cognitive assessment—Brief International Cognitive Assessment for multiple sclerosis (MS), cardiorespiratory fitness, 6-minute walk, physical activity, depressive symptoms, perceived fatigue—Modified Fatigue Impact Scale (MFIS), MS impact—MSIS-29, and walking ability. Results: Of 298 participants, 153 (51%) presented WF (DWI = −28.9 ± 22.1%) and 196 (66%) presented CF (−29.7 ± 15%). Clinical characteristics (EDSS, disease duration, and use of assistive device) were worse in patients with versus without WF. They also presented worse scores on MSIS-29 physical, MFIS total and physical and reduced physical capacity. CF patients scored better in the MSIS-29 physical and MFIS psychosocial, compared to non-CF group. Magnitude of CF and WF were not related. Conclusions: Half of the cognitively-impaired PMS population presented WF which was associated with higher disability, physical functions, and fatigue. There was a high prevalence of CF but without strong associations with clinical, cognitive, and physical functions. Trial Registration Number: The “CogEx-study,” www.clinicaltrial.gov identifier number: NCT03679468.

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Section: Methodsmentioning

confidence: 99%

Prevalence and Associated Clinical Characteristics of Walking-Related Motor, Cognitive, and Fatigability in Progressive Multiple Sclerosis: Baseline Results From the CogEx Study

Ramari,

D’hooge,

Dalgas

et al. 2024

Neurorehabil Neural Repair

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“…There is increasing interest in the remote assessment of participants in clinical trials, the importance of which was additionally highlighted due to the impact of the COVID-19 pandemic on clinical trials [17,18]. As shown in Fig.…”

Section: Overcoming Issues That Contribute To Ineligibilitymentioning

confidence: 99%

Optimising recruitment in clinical trials for progressive multiple sclerosis: observational analysis from the MS-SMART and MS-STAT2 randomised controlled trials

Williams

Alexander

Blackstone

et al. 2022

Trials

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Background Slower than planned recruitment is a major factor contributing to the delay or failure of randomised controlled trials to report on time. There is a limited evidence base regarding the optimisation of recruitment strategies. Here we performed an observational review of our experience in recruitment for two large randomised controlled trials for people with secondary progressive multiple sclerosis. We aimed to explicitly determine those factors which can facilitate trial recruitment in progressive neurodegenerative disease. Methods Recruitment data from the sequential MS-SMART [NCT01910259] and MS-STAT2 [NCT03387670] UK randomised controlled trials was reviewed from the largest recruiting site, University College London (UCL). The trial population was similar which allowed comparison over the two recruitment periods of 2015–2016 and 2018–2021. This included sources of referral, progress through stages of recruitment, reasons for participant ineligibility and the impact of publicity events upon recruitment. Results In MS-SMART, 18% of patients contacted were enrolled, compared to 27% for MS-STAT2. Online registration of interest portals provided the greatest number of referrals (76% in MS-SMART, and 51% in MS-STAT2), with publicity in national media outlets producing a demonstrable increase in the number of potential participants. The introduction of an online self-screening questionnaire for MS-STAT2 resulted in 67% of potential participants (3080 of 4605) automatically determining their own ineligibility. In both studies, however, around 60% of those directly telephoned to discuss the study were not eligible, with difficulties related to travel to trial visits, or excluded medication, being the most common issues. Eighty-four percent of those deemed potentially eligible following telephone calls were enrolled in the MS-STAT2 study, compared to only 55% for MS-SMART. Conclusions Through a detailed review of recruiting participants at the largest centre into two large randomised controlled trials with similar entry criteria, we have identified a number of approaches that may improve recruitment efficiency. We highlight here the importance of mandatory online self-screening questionnaires, a coordinated publicity campaign, and simple interventions such as eligibility checklists and appointment reminders. Recruitment approaches should be further assessed through a studies within a trial (SWAT) design. Trial registration MS-SMART: NCT01910259; registered July 2013 and MS-STAT2: NCT03387670; registered Jan 2018

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The late onset of emotional distress in people with progressive multiple sclerosis during the Covid-19 pandemic: longitudinal findings from the CogEx study

et al. 2022

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Objective An earlier follow-up study from the CogEx rehabilitation trial showed little change in symptoms of depression, anxiety and psychological distress during the first COVID-19 lockdown compared to pre-pandemic measurements. Here, we provide a second follow-up set of behavioral data on the CogEx sample. Methods This was an ancillary, longitudinal follow-up study in CogEx, a randomized controlled trial of exercise and cognitive rehabilitation in people with progressive MS involving 11 centres in North America and Europe. Only individuals impaired on the Symbol Digit Modalities Test (SDMT) were included. Participants repeated the COVID Impact survey administered approximately a year later and completed self-report measures of depression, anxiety and MS symptoms that had been obtained at the trial baseline and during the first COVID Impact survey. Participants who completed the second COVID Impact follow-up were included. To identify predictors of the participants’ ratings of their mental and physical well-being, step-wise linear regression was conducted. Results Of the 131 participants who completed the first COVID impact survey, 74 participants completed the second follow-up survey (mean age 52 (SD = 6.4) years, 62.2% female, mean disease duration 16.4 (SD = 9.0) years, median EDSS 6.0). Pandemic restrictions prevented data collection from sites in Denmark and England ( n = 57). The average time between measurements was 11.4 (SD = 5.56) months. There were no significant differences in age, sex, EDSS, disease course and duration between those who participated in the current follow-up study ( n = 74) and the group that could not ( n = 57). One participant had COVID in the time between assessments. Participants now took a more negative view of their mental/psychological well-being ( p = 0.0001), physical well-being ( p = 0.0009) and disease course ( p = 0.005) compared to their last assessment. Depression scores increased on the HADS-depression scale ( p = 0.01) and now exceeded the clinically significant threshold of ≥ 8.0 for the first time. Anxiety scores on the HADS remained unchanged. Poorer mental well-being was predicted by HADS depression scores ( p = 0.012) and a secondary-progressive disease course ( p = 0.0004). Conclusions A longer follow-up period revealed the later onset of clinically significant depressive symptoms on the HADS and a decline in self-perceptions of mental and physical well-being associated with the COVID-19 pandemic relative to the first follow-up data point. Trial registration The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Regist...

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The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience

Cited by 5 publications

References 14 publications

Prevalence and Associated Clinical Characteristics of Walking-Related Motor, Cognitive, and Fatigability in Progressive Multiple Sclerosis: Baseline Results From the CogEx Study

Prevalence and Associated Clinical Characteristics of Walking-Related Motor, Cognitive, and Fatigability in Progressive Multiple Sclerosis: Baseline Results From the CogEx Study

Optimising recruitment in clinical trials for progressive multiple sclerosis: observational analysis from the MS-SMART and MS-STAT2 randomised controlled trials

The late onset of emotional distress in people with progressive multiple sclerosis during the Covid-19 pandemic: longitudinal findings from the CogEx study

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