Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 4, 2020
Date Accepted: Jun 13, 2020
Date Submitted to PubMed: Jun 16, 2020
A description of Covid-19 modifications to the TEAMS study protocol for remotely delivering teleassessment/teletraining of complementary alternative medicine among people with multiple sclerosis
ABSTRACT
Background:
Access to comprehensive exercise/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 Covid-19 in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all non-essential research requiring on-site visits, including the TEAMS study.
Objective:
In compliance with the shelter-in-place policy and quarantine guidance during Covid-19, a modified testing and training protocol was developed to allow participants to continue the study.
Methods:
The modified protocol, which replaces the on-site data collection and training procedures, includes a teleassessment package (laptop computer, blood pressure cuff, hand dynamometer, mini- disc cone, measuring tape, an 8” step, and a large print 8”x11” paper with ruler metrics and wall-safe tape) and virtual meeting platform for synchronous interactive training between therapist and participant. The teleassessment measures include resting blood pressure and heart rate, the Hand-Grip Strength Test; Five Times Sit to Stand test; Timed Up & Go test; and 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 one-year post-training.
Results:
The protocol modifications were supported with supplemental and enhancement funding (Patient-Centered Outcomes Research Institute [PCORI]) and approved by the University Institutional Review Board for Human Use. At the time non-essential research visits were halted by the University, there were 759 people enrolled and baseline tested in the study (92.5% of our baseline testing completion target: 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 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 discontinued the study. Clinical Trial: ClinicalTrials.gov NCT03117881
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