Citation

Classen S, Li Y, Giang W, Winter S, Wei J, Patel B, Jeghers M, Gibson B, Rogers J, Ramirez-Zamora A. Contemp. Clin. Trials Commun. 2022; 28: e100954.

Copyright

(Copyright © 2022, Elsevier Publishing)

DOI

10.1016/j.conctc.2022.100954

PMID

35812823

PMCID

PMC9256542

Abstract

INTRODUCTION: Driving is an essential facilitator of independence, community participation, and quality of life. Drivers with Parkinson's Disease (PD) make more driving errors and fail on-road evaluations more than healthy controls. In-vehicle technologies may mitigate PD-related driving impairments and associated driving errors. Establishing a rigorous study protocol will increase the internal validity and the transparency of the scientific work.

METHODS: We present a protocol to assess the efficacy of autonomous in-vehicle technologies (Level 1) on the driving performance of drivers with PD via a randomized crossover design with random allocation. Drivers with a PD diagnosis based on established clinical criteria (N = 105), referred by neurologists, are exposed to two driving conditions (technology activated or not) on a standardized road course as they drove a 2019 Toyota Camry. The researchers collected demographic, clinical, on-road data observational and kinematic, and video data to understand several primary outcome variables, i.e., number of speeding, lane maintenance, signaling, and total driving errors.

DISCUSSION: The protocol may enhance participant adherence, decrease attrition, provide early and accurate identification of eligible participants, ensure data integrity, and improve the study flow. One limitation is that the protocol may change due to unforeseen circumstances and assumptions upon implementation. A strength is that the protocol ensures the study team executes the planned research in a systematic and consistent way.Following, adapting, and refining the protocol will enhance the scientific investigation to quantify the nuances of driving among those with PD in the era of automated in-vehicle technologies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04660500.

Language: en

Keywords

Automated in-vehicle technologies; Driver rehabilitation specialist; Driving intervention; Kinematic data; Parkinson's disease; RCT; Study protocol