Design
infection, cognitive decline, traumatic brain injury
INFECTION, RECRUITMENT, SLEEP APNEA
A protocol-driven, uncontrolled, pragmatic trial was used in order to test feasibility and estimate effects in a real-world clinical setting. This research was approved by the Institutional Review Board (IRB) at the National University of Natural Medicine and was registered on ClinicalTrials.gov as NCT04284449. Participants attended a minimum of four clinical visits with additional clinical visits as needed. Recruitment began in February 2020, but was paused due to the SARS-CoV-2 pandemic and nation-wide quarantine measures. Recruitment resumed in August 2020 and concluded in March of 2022.Following a baseline assessment, a multimodal, individualized care plan was created, driven by the identification of contributors to cognitive decline (e.g., nutritional status, infection, toxicant burden, vascular health, sleep apnea, traumatic brain injury, etc.). Data collection took place at four study visits (baseline, one month, three months, and six months), and at the 12-month follow-up visit. The six-month study visit was specified a priori as the primary endpoint. Study participants received weekly phone calls for nutrition support from health coaches and/or clinical research staff throughout the six months of study participation and active data collection. Care plans were modified throughout study involvement based on individual participant response (i.e., the treating clinician took into account challenges to adherence, feasibility, etc., to tailor the care plan).Participants were allowed to have a Health Care Proxy with them at study visits, if they chose to, and having a proxy was a requirement for participants with a Montreal Cognitive Assessment (MoCA) score from 12–16 (indicating moderate impairment) upon screening [