Cond Challenges and strategies in conducting randomized clinical trials during COVID-19
an experience report
DOI:
https://doi.org/10.5281/zenodo.20467101Keywords:
Controlled Clinical Trial, Pandemics, Nursing, CaregiversAbstract
Introduction: The COVID-19 pandemic imposed sanitary restrictions that disrupted schedules and required adjustments in field studies, especially those conducted at home. Objective: To report the experience of conducting a randomized clinical trial with family caregivers, highlighting challenges and solutions adopted to ensure safety and standardization. Experience report: The study was developed between 2020 and 2022, linked to a public home care program. The protocol was restructured to reduce exposure time and ensure methodological rigor, with telephone screening, remote team training, web conference scripts, operational checklists, response cards to expedite instruments, territorial organization of visits, and a flow manual for applying the self-reminiscence and writing intervention. Biosafety measures were implemented with standardized use of PPE and systematic recording of data collection stages. Final considerations: The methodological flexibility associated with the use of educational technologies and collaborative management enabled the continuation of the trial safely and consistently, preserving data integrity and care for participants. This report summarizes practical strategies for teams conducting research in adverse contexts and can guide the planning of future research in health outreach and education.
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Copyright (c) 2026 Michele Rodgrigues Fonseca, Stefanie Griebeler Oliveira, Fernanda Sant’Ana Tristão, Fernanda Eisenhardt de Mello, Maria Clara Chagas, Virginia Ferreira da Silva
This work is licensed under a Creative Commons Attribution 4.0 International License.
