Background Coronavirus disease 2019 (COVID-19) has a heterogeneous outcome in individuals from remaining asymptomatic to death. In a majority of cases, mild symptoms are present that do not require hospitalization and can be successfully treated in the outpatient setting, though symptoms may persist for a long duration. We hypothesize that drugs suitable for decentralized study in outpatients will have efficacy among infected outpatients Methods The TREAT NOW platform is designed to accommodate testing multiple agents with the ability to incorporate new agents in the future. TREAT NOW is an adaptive, blinded, multi-center, placebo-controlled superiority randomized clinical trial which started with two active therapies (hydroxychloroquine and lopinavir/ritonavir) and placebo, with the hydroxychloroquine arm dropped shortly after enrollment began due to external evidence. Each arm has a target enrollment of 300 participants who will be randomly assigned in an equal allocation to receive either an active therapy or placebo twice daily for 14 days with daily electronic surveys collected over days 1 through 16 and on day 29 to evaluate symptoms and a modified COVID-19 ordinal outcome scale. Participants are enrolled remotely by telephone and consented with a digital interface, study drug is overnight mailed to study participants, and data collection occurs electronically without in-person interactions. Discussion If effective treatments for COVID-19 can be identified for individuals in the outpatient setting before they advance to severe disease, it will prevent progression to more severe disease, reduce the need for hospitalization, and shorten the duration of symptoms. The novel decentralized, “no touch” approach used by the TREAT NOW platform has distinction advantages over traditional in-person trials to reach broader populations and perform study procedures in a pragmatic yet rigorous manner. Trial registration ClinicalTrials.gov NCT04372628. Registered on April 30, 2020. First posted on May 4, 2020.
Objective Treatment of obesity-related diseases, rather than obesity itself, remains the mainstay of medical care. The current study examined a novel approach that prioritizes weight management in primary care to shift this paradigm. Methods PATHWEIGH is a weight management approach consisting of staff team training, workflow system management, and data capture from tools built into the electronic medical record (EPIC). PATHWEIGH was compared to standard of care (SOC) using two family medicine clinics in the same US healthcare system. Descriptive statistics compared patient-, provider-, and clinic-level factors between the groups among those with at least one weight-prioritized visit (WPV) and one follow-up weight over 14 months. Results Groups were similar in terms of total patient visits (7,353 vs. 7,984) and patients eligible for a WPV (i.e. >18 years + body mass index >25 kg/m2; 3,746 vs. 3,008, PATHWEIGH vs. SOC, respectively). However, more PATHWEIGH clinic patients (15.9% vs. 8.4%; P < 0.001) received at least one WPV. Although no difference was observed for average patient weight loss over 14 months (P = 0.991), the number of WPVs per patient was higher in PATHWEIGH (P < 0.001) and significantly associated with weight loss (P = 0.001), with an average decrease in weight of 0.55 kg per additional visit. Conclusions Results from the current study demonstrate early success in changing the paradigm from treating weight-related comorbidities to treating weight in primary care.
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