Home Visit Nurses Deliver Complete Trial Data Despite A Challenging Population, A Pandemic And Severe Weather

Navigating the complexities of a Phase 3 clinical trial for Rett syndrome, PCM Trials demonstrated exceptional resilience and adaptability. Rett syndrome, a rare and progressively degenerative neurological disorder primarily affecting young girls, presents significant challenges, including severe mobility issues, communication difficulties, and frequent seizures. Conducted over four years and spanning the peak of the COVID-19 pandemic, this trial necessitated innovative approaches to ensure its success.

Faced with the closure of numerous sites and the logistical hurdles of a pandemic, the study transitioned to a hybrid model, leveraging the expertise of PCM Trials' mobile research nurses. These nurses played a critical role in maintaining data consistency and patient compliance, conducting complex home visits that included vitals analysis, ECGs, and PD/PK sampling. Despite severe weather and pandemic-related obstacles, the nurses ensured timely data collection and sample delivery, contributing to the trial's over-enrollment and high retention rates.

This case study highlights the pivotal role of mobile nursing visits in overcoming logistical challenges, ensuring participant retention, and maintaining high-quality data collection in decentralized clinical trials.