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://ichgcp.net/clinical-trials-registry/NCT03117881.

International registered report identifier (irrid): DERR1-10.2196/18415.

Keywords: COVID-19; disability; multiple sclerosis; physical activity; tele-exercise; telehealth; telerehabilitation; teletraining.

Conflict of interest statement

Conflicts of Interest: None declared.

©Byron Lai, Chia-Ying Chiu, Emily Pounds, Tracy Tracy, Tapan Mehta, Hui-Ju Young, Emily Riser, James Rimmer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.07.2020.

Figures

Figure 1

An example of a person with multiple sclerosis exercising in their home with the intervention equipment and computer tablet.

Figure 2

An example of the videoconference view of the starting position for the Five Times Sit to Stand test.

Figure 3

An example of the videoconference view for the Timed Up & Go test.

Figure 4

An example of the videoconference view for the starting position of the functional reach task of the Berg Balance Scale.

Figure 5

A teleassessment package prior to being shipped to a participant's home. The equipment includes an 8" step, a blood pressure cuff, a roll of wall-safe tape, a 3-meter measuring tape, a hand dynamometer, a mini disc cone, a large print paper with ruler metrics, a sheet with participant instructions (under the step), and a computer laptop (bottom).

Figure 6

Modified CONSORT (Consolidated Standards of Reporting Trials) diagram reporting the number of teleassessments that need to be completed and participants who need to undergo rDirectCAM. COVID-19: coronavirus disease.