Objective To report initial results of a planned multicenter year‐long prospective study examining the risk and impact of COVID‐19 among persons with neuroinflammatory disorders (NID), particularly multiple sclerosis (MS). Methods In April 2020, we deployed online questionnaires to individuals in their home environment to assess the prevalence and potential risk factors of suspected COVID‐19 in persons with NID (PwNID) and change in their neurological care. Results Our cohort included 1115 participants (630 NID, 98% MS; 485 reference) as of 30 April 2020. 202 (18%) participants, residing in areas with high COVID‐19 case prevalence, met the April 2020 CDC symptom criteria for suspected COVID‐19, but only 4% of all participants received testing given testing shortages. Among all participants, those with suspected COVID‐19 were younger, more racially diverse, and reported more depression and liver disease. PwNID had the same rate of suspected COVID‐19 as the reference group. Early changes in disease management included telemedicine visits in 21% and treatment changes in 9% of PwNID. After adjusting for potential confounders, increasing neurological disability was associated with a greater likelihood of suspected COVID‐19 (OR adj = 1.45, 1.17–1.84). Interpretations Our study of real‐time, patient‐reported experience during the COVID‐19 pandemic complements physician‐reported MS case registries which capture an excess of severe cases. Overall, PwNID seem to have a risk of suspected COVID‐19 similar to the reference population.
Objective.Conduct a pilot randomized clinical trial to determine whether participation in a group-based structured telehealth intervention increases physical activity in people with multiple sclerosis (MS).Methods.In this parallel-arms trial, all study procedures were administered remotely. Adults diagnosed with MS (any subtype) were randomized to one of two 12-week (1 hour/week) active conditions: eFIT, online moderated structured groups; or eJournal, online independent journaling. For comparison, treatment as usual (TAU; i.e., no eFIT / eJournal) group was enrolled. Primary outcome was feasibility (completion, adherence). Secondary efficacy outcomes included self-reported physical activity level (International Physical Activity Questionnaire, IPAQ).Results.Participants were 37 adults with MS. Sample was diverse: 66.7% female; age range 23-64 years; 17.5% Hispanic, 12.5% Black; progressive and relapsing-remitting disease subtypes. Regarding feasibility, 70.7% completed; average adherence was 74.9%. Physical activity in active groups increased by 34.2% (baseline IPAQ= 2406.8 ± 1959.7, follow-up= 3229.4 ± 2575.2); decreased in TAU group by 17.4% (baseline=2519.9 ± 1500.1, follow-up=2081.2 ± 1814.9); group x time interaction was not statistically significant [F(2, 25)=1.467, p=.250; partial η2= .105].Conclusionsand relevance. Telehealth represents an accessible, acceptable vehicle to deliver targeted behavioral treatments to a neurological population. eFIT may be an effective intervention for increasing physical activity, a historically intractable treatment target, in individuals with MS. Additionally, these results provide evidence for feasibility of conducting fully remote clinical trial research.Classification of evidence:This study provides Class II evidence that for people with MS, participation in a group-based structured telehealth intervention compared to treatment as usual did not significantly change self-reported physical activity level or the percentage of participants who completed follow-up questionnaires. The trial was registered at ClinicalTrials.gov (NCT03829267).
Objective Anxiety is common among persons with MS (PwMS), but widely accepted treatments are lacking. Group-based interventions delivered via telehealth are an accessible treatment option requiring clinical trial evidence to support feasibility and initial efficacy. We conducted a pilot feasibility trial of an online support group intervention to reduce anxiety in PwMS. Methods A non-randomized, parallel arm clinical trial was conducted. A total of 31 PwMS were enrolled: 20 completed a 12-week telehealth-delivered support group intervention and 11 were assigned to a survey-only control group. Primary feasibility outcomes were adherence and completion rates. Primary efficacy outcome was anxiety, secondary outcomes were depression, loneliness, distress, self-efficacy, stress, and quality of life. Results Twenty-six participants completed the study. Intervention group adherence (75%) and completion (85%) rates were acceptable. Results indicated a medium size between-group effect, suggesting a greater reduction in anxiety in the intervention group compared to the control group [ U = 39.50, p = 0.045, r = 0.39]. No group differences in other outcomes were observed. Conclusion A telehealth-delivered support group intervention appears feasible for further study and shows initial efficacy for the reduction of anxiety in PwMS.
IntroductionThe many benefits of exercise for persons with multiple sclerosis (MS) are well established, yet patients often refrain from exercise due to overheating and exhaustion. The present randomised controlled trial tests aspirin (acetylsalicylic acid (ASA)) as a convenient method to prevent overheating and improve exercise performance in persons with MS. The effects of ASA are compared with those of acetaminophen (APAP) and placebo.Methods and analysisParticipants are seen for a laboratory maximal exercise test on 3 separate days separated by at least 1 week. At each session, body temperature is measured before oral administration of a standard adult dose (650 mg) of ASA, APAP or placebo. One hour after drug administration, participants perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (that is, time spent cycling to peak exertion) and (b) body temperature change. Crossover analyses will include tests for effects of treatment, period, treatment–period interaction (carryover effect) and sequence.Ethics and disseminationEthical approval was granted by the institutional review board at Columbia University Irving Medical Center (reference: AAAS2529). Results of the trial will be published in peer-reviewed scientific journals and presented at national and international conferences. Neurologists, physiatrists, primary care physicians and physiotherapists are important stakeholders and will be targeted during dissemination. Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.Trial registration numberNCT03824938.
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