Centralized Hub Successfully Delivers Remote Interventions in Multisite Clinical Trial

Digital health technologies now enable the remote delivery of clinical interventions, creating new opportunities to redesign multisite clinical trials. Traditional multisite trials require participating sites to deliver interventions independently, potentially increasing implementation variability and operational complexity across locations. Centralized models instead allow participating sites to conduct local participant recruitment, consent, and clinical assessments while coordinating intervention delivery entirely through one operational hub. Researchers demonstrated the feasibility of this model in RECOVER-NEURO, an NIH-funded, five-arm phase 2 randomized trial overseen by the Duke Clinical Research Institute.

The RECOVER-NEURO trial enrolled 328 participants across 22 United States clinical sites to study cognitive symptoms associated with long COVID. Under this operational design, duties were strategically divided between the local participating sites and a central hub established at NYU Langone Health. Participating clinical sites conducted participant recruitment, obtained informed consent, and performed standardized clinical assessments. Meanwhile, the central hub at NYU Langone Health managed study kit preparation and distribution, device programming, onboarding, remote supervision, adherence monitoring, and equipment recovery.

Participants in the trial were randomized into five distinct intervention arms to receive home-based digital and device-delivered therapies over a 10-week period. The interventions included BrainHQ cognitive training alone; BrainHQ paired with cognitive rehabilitation, designated as PASC-CoRE, delivered via telehealth by investigators from Mount Sinai and Emory University; BrainHQ combined with active transcranial direct current stimulation, known as tDCS; BrainHQ combined with sham tDCS; or non-adaptive computer-based puzzles and games serving as an active comparator. All interventions were delivered remotely to participants’ homes using specialized study kits prepared, configured, and tracked by the central hub staff.

The centralized operational model demonstrated high rates of participant engagement and protocol completion across the cohort. Out of 328 enrolled individuals, 320 participants received an intervention, and 260 participants, or 81.3 percent, were consistently adherent to their assigned regimen. Over the course of the 10-week intervention phase, participants completed a mean of 44.0 ± 10.9 sessions over 68.8 ± 11.3 days. Operational metrics revealed that the central hub initiated intervention delivery within a mean of 13.5 ± 6.1 days of first participant contact. Additionally, the hub infrastructure proved capable of managing substantial workflow volume, supporting up to 168 concurrently active participants during peak trial operations.

The entire intervention phase was completed in 375 days, and the centralized management strategy achieved an overall equipment return rate of 96.9 percent. Registered on ClinicalTrials.gov under identifier NCT05965739, these findings demonstrate the operational feasibility of centralized remote delivery of digital and device-based interventions in a large multisite trial. The authors note that this centralized model successfully addresses the logistical complexity of multisite studies and may inform the structural design, standardized execution, and operational management of future decentralized or hybrid clinical trials.

Subject of Research: Centralized hub model for remote intervention delivery in multisite clinical trials

Article Title: A central hub model for remote delivery of multisite clinical trial interventions

Article References: Charvet, L., Pilloni, G., Becker, J. H., Wisnivesky, J., Federman, A. D., Pehel, S., Ko, T. S., Koltai, D. C., Knopman, D. S., Laskowitz, D. T., O’Steen, A., James, M., Cox, W., Karwowski, J., & Zimmerman, K. O. (2026). A central hub model for remote delivery of multisite clinical trial interventions. PLOS Digital Health, 5(11), e0001818. https://doi.org/10.1371/journal.pdig.0001818

Image Credits: AI Generated

DOI: 10.1371/journal.pdig.0001818

Keywords: centralized clinical trials, RECOVER-NEURO, long COVID, remote intervention delivery, digital health technologies, decentralized trials, BrainHQ, transcranial direct current stimulation, tDCS, PASC-CoRE, cognitive rehabilitation, Duke Clinical Research Institute, NYU Langone Health, treatment adherence, study kit distribution, hybrid clinical trials, telehealth interventions