Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic

Contemp Clin Trials. 2021 Jun;105:106407. doi: 10.1016/j.cct.2021.106407. Epub 2021 Apr 20.

Abstract

The coronavirus disease-2019 (COVID-19) pandemic has changed the conduct of clinical trials. For studies with physical function and physical activity outcomes that require in-person participation, thoughtful approaches in transitioning to the remote research environment are critical. Here, we share our experiences in transitioning from in-person to remote assessments of physical function and activity during the pandemic and highlight key considerations for success. Details on the development of the remote assessment protocol, integration of a two-way video platform, and implementation of remote assessments are addressed. In particular, procedural challenges and considerations in transitioning and conducting remote assessments will be discussed in terms of efforts to maintain participant safety, maximize study efficiency, and sustain trial integrity. Plans for triangulation and analysis are also discussed. Although the role of telehealth platforms and research activities in remote settings are still growing, our experiences suggest that adopting remote assessment strategies are useful and convenient in assessing study outcomes during, and possibly even beyond, the current pandemic. Trial register and number: ClinicalTrials.gov [NCT03728257].

Keywords: COVID-19; Clinical trials; Physical activity; Physical function; Remote assessments.

Publication types

  • Clinical Trial Protocol
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Actigraphy
  • COVID-19 / epidemiology*
  • Clinical Protocols
  • Exercise / physiology*
  • Exercise Test / methods
  • Humans
  • Lung Transplantation / rehabilitation*
  • Pandemics
  • Patient Safety
  • Postural Balance / physiology
  • Quality of Life
  • Research Design*
  • SARS-CoV-2
  • Telemedicine
  • Videoconferencing

Associated data

  • ClinicalTrials.gov/NCT03728257