A central hub model for remote delivery of multisite clinical trial interventions
Year: 2026
Type: article
Abstract: Digital health technologies enable remote delivery of clinical interventions, creating opportunities to redesign multisite trials. Traditional trials require participating sites to deliver interventions independently, potentially increasing implementation variability and operational complexity. Centralized models instead allow local recruitment and assessments while coordinating intervention delivery through one hub. We describe 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 trial enrolled 328 participants across 22 US sites with cognitive symptoms associated with long COVID. Sites conducted recruitment, consent, and clinical assessments, while an NYU Langone Health hub managed study kit preparation and distribution, device programming, onboarding, remote supervision, adherence monitoring, and equipment recovery. Participants were randomized to BrainHQ cognitive training alone; BrainHQ plus cognitive rehabilitation (PASC-CoRE), delivered via telehealth by Mount Sinai and Emory University investigators; BrainHQ plus active transcranial direct current stimulation (tDCS); BrainHQ plus sham tDCS; or non-adaptive computer-based puzzles and games as an active comparator. Interventions were delivered remotely over 10 weeks using home-based study kits. Participants completed a mean of 44.0 ± 10.9 sessions over 68.8 ± 11.3 days. Of 320 participants who received intervention, 260 (81.3%) were consistently adherent. The hub initiated intervention within 13.5 ± 6.1 days of first participant contact, supported up to 168 concurrently active participants, and achieved a 96.9% equipment return rate. The intervention phase was completed in 375 days. These findings demonstrate the feasibility of centralized remote delivery of digital and device-based interventions in a large multisite trial and may inform future decentralized or hybrid clinical trials. Trial Registration ClinicalTrials.gov Identifier: NCT05965739 .
Source: PLOS Digital Health
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,043
OpenAlex ID: W7225820892