Dataset Information

COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. OBJECTIVE:In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. METHODS:The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8" step, and a large-print 8" × 11" paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. RESULTS:The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. CONCLUSIONS:This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. TRIAL REGISTRATION:ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/18415.

SUBMITTER: Lai B

PROVIDER: S-EPMC7337611 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.

Lai Byron B Chiu Chia-Ying CY Pounds Emily E Tracy Tracy T Mehta Tapan T Young Hui-Ju HJ Riser Emily E Rimmer James J

JMIR research protocols 20200703 7

<h4>Background</h4>Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the Univ ...[more]

PMID: 32540838

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Project description:BackgroundThere is growing interest in the use of complementary and alternative medicine (CAM) throughout the world, however previous research done in Japan has focused primarily on CAM use in major cities. The purpose of this study was to develop and distribute a Japanese version of the International Complementary and Alternative Medicine Questionnaire (I-CAM-Q) to assess the use of CAM among people who visit rural Japanese family medicine clinics.MethodsUsing a Japanese version of the International Complementary and Alternative Medicine Questionnaire (I-CAM-Q), a cross-sectional survey was conducted in three rural family medicine clinics. All patients and those accompanying patients who met inclusion criteria were eligible to participate. Data were entered into SPSS Statistics and analyzed for use by age, gender, and location.ResultsOf the 519 respondents who participated in the project, 415 participants reported CAM use in the past 12 months (80.0%). When prayer is excluded, the prevalence of CAM use drops to 77.3% in the past year, or 403 respondents. The most common forms of CAM used by respondents were pain relief pads (n = 170, 32.8%), herbal medicines/supplements (n = 167, 32.2%), and massage by self or family (n = 166, 32.0%). Female respondents, individuals with higher levels of education, and those with poorer overall health status were more likely to use CAM than respondents without these characteristics. Only 22.8% of CAM therapies used were reported to physicians by survey participants.ConclusionsThese data indicate that CAM use in rural Japan is common. The results are consistent with previous studies that show that Japanese individuals are more interested in forms of CAM such as pain relief pads and massage, than in mind-body forms of CAM like relaxation and meditation. Due to the high utilization of certain CAM practices, and given that most CAM users do not disclose their CAM use to their doctors, we conclude that physicians in rural Japan would benefit by asking about CAM use during patient interviews, and by familiarizing themselves with the potential benefits and risks of commonly used CAM modalities.

Project description:ObjectiveTo develop evidence-based recommendations for complementary and alternative medicine (CAM) in multiple sclerosis (MS).MethodsWe searched the literature (1970-March 2011; March 2011-September 2013 MEDLINE search), classified articles, and linked recommendations to evidence.Results and recommendationsClinicians might offer oral cannabis extract for spasticity symptoms and pain (excluding central neuropathic pain) (Level A). Clinicians might offer tetrahydrocannabinol for spasticity symptoms and pain (excluding central neuropathic pain) (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term) (Level C). Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols) for spasticity symptoms, pain, and urinary frequency (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). Clinicians might choose not to offer these agents for tremor (Level C). Clinicians might counsel patients that magnetic therapy is probably effective for fatigue and probably ineffective for depression (Level B); fish oil is probably ineffective for relapses, disability, fatigue, MRI lesions, and quality of life (QOL) (Level B); ginkgo biloba is ineffective for cognition (Level A) and possibly effective for fatigue (Level C); reflexology is possibly effective for paresthesia (Level C); Cari Loder regimen is possibly ineffective for disability, symptoms, depression, and fatigue (Level C); and bee sting therapy is possibly ineffective for relapses, disability, fatigue, lesion burden/volume, and health-related QOL (Level C). Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs nonstandardized cannabis extracts and overall CAM quality control/nonregulation. Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown.

Project description:Mindfulness-based interventions, modified and shortened versions of meditation teachings, have proved to be effective in the improvement of quality of life in many clinical conditions, including chronic diseases. Preliminary results available in the literature and in clinical experience indicate a high potential for this treatment for the reduction of psychological suffering in people with chronic diseases.This randomized controlled trial will investigate the impact of a multiple sclerosis (MS) specific telemedicine meditation intervention on the quality of life of people with multiple sclerosis and their caregivers. This trial will recruit 120 patients, men and women, with a diagnosis of relapsing-remitting or secondary progressive MS and their caregivers to participate in a 2-month intervention. Patients will undergo assessments of quality of life, anxiety, depression, quality of sleep, mindfulness and fatigue levels conducted at baseline, at week 8 (conclusion of the intervention) and at week 27 (6 months follow-up). Caregivers will complete assessments conducted at the same time for the same areas, plus caregiver burden. The intervention condition will consist of 2 hours/week of online meditation in a group setting led by a trainer, plus 1 hour/week of individual exercises. The control condition will incorporate a psycho-education online program and will require the same contact time commitment as the intervention condition.Primary outcome measures will consist of assessments of quality of life, anxiety, and depression level. Assessments of mindfulness level, quality of sleep and fatigue level will be considered secondary outcome measures. This investigation will increase understanding of the role of meditation as part of a treatment plan for people with MS and their caregivers. Overall, this study design has the potential to lead to effective meditation intervention strategies for this population and improve their quality of life.Clinical Trials Register NCT02364505. https://clinicaltrials.gov/ct2/show/NCT02364505.

Dataset Information

COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.

Publications

COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.

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