ABSTRACT
Background: Due, partially, to the COVID-19 pandemic, interest in remote clinical trials has grown rapidly. The convenience associated with remote trials, for both researchers and participants, can lead to improved recruitment, retention, and engagement. Advancements in digital technology have led to increased accessibility to remote healthcare and have made possible remote data collection and intervention delivery in clinical trials. However, remote clinical trials are not ''one-sizefits- all'' and present key challenges, particularly, when there are multi-component outcomes, for example, the metabolic syndrome (MetS). Motivated by an ongoing, in-person, national, multi-site clinical trial aimed at the remission of the MetS (ELM trial), the Virtual ELM pilot study assessed the plausibility of remote data collection and delivery of a lifestyle intervention to participants with the MetS. It focused on weight loss after a 3-month treatment, which was used as a surrogate measure for the MetS. Objective(s): To assess the feasibility and remediate challenges of a fully remote data collection and intervention delivery for translation into a large-scale remote clinical trial. Method(s): A treatment-only pilot study was conducted with 10 participants with the MetS. Participants were recruited via self-referral or medical records interrogation. They attended virtual group meetings via Zoom led by trained interventionists every week for three consecutive months to practice mindful exercise and eating. Intervention tools, such as participant selfmonitoring, included daily food intake, mindful habit logs and daily steps. All data collection was completed remotely including weight and components of the MetS (waist circumference, blood pressure, glucose, HDL, and triglycerides). Other outcomes included physical activity, diet, and mindfulness. Remote data collection was conducted using a variety of tools including Snap Surveys (web-based questionnaires), Actigraph/ CentrePoint (accelerometer-based physical activity), Fitabase (weight, steps, and food logs). Accelerometers, blood pressure monitors, Fitbit activity trackers, wireless scales, and waist measuring tapes were mailed to participants, along with instructions on how to use them. Participants visited Quest Diagnostics to complete blood draws. Result(s): There were several challenges such as remote recruitment, outcomes data collection, and intervention delivery. The most distinctive challenges were completion of the accelerometer and blood draw protocols. Despite the challenges, this pilot achieved 100% retention for both baseline and follow-up outcomes assessments and 95% remote session attendance. Thirty percent of the sample achieved remission of MetS and 40% achieved weight loss >=5%. The screening-toenrollment ratio was 2.0. Conclusion(s): The Virtual ELM pilot study showed promising results for the possibility of efficient execution of a remote, large-scale trial. The study helped identify challenges associated with its virtual nature, such as physical measures and physical activity protocol completion, and resourceful delivery of the intervention content. Proactively addressing challenges in the enrollment phase, for example, screening for smartphone technology awareness and refinement in the planning phase, for example, selecting effective data capture tools, is essential for a successful, remote trial.
ABSTRACT
OBJECTIVES: Extracorporeal membrane oxygenation is of crucial importance for the treatment of acute or chronic lung diseases and gains even more significance with the increasing prevalence of Covid-19. In recent years, some modifications of the gas exchange membranes have been made which led to improvements in gas exchange properties and hemocompatibility, but a long-term solution is still not within reach. Blood contact with the membranes and tubes leads to activation of the coagulation, complement system and to inflammatory reactions. The competitive plasma protein adsorption within the first minutes mainly determines the reaction against the material and thus the fate of the oxygenators. Therefore, we aimed at investigating the time- and flowdependent plasma protein adsorption on oxygenator membranes to better understand the complex interactions on the surface. METHODS: Miniature oxygenator devices were built from PVC tubes and polycarbonate connectors. Heparin-coated and uncoated hollow fibre membranes were rolled to fit into the miniature devices. The circuit with tubes and miniature oxygenators was filled with human plasma and pumped through the heated circuit for 1 minute up to 6 hours (roller pumps). Afterwards, haemocompatibility parameters according to ISO10993-4 were examined and the oxygenator membranes used were washed and proteins desorbed. The resulting protein solutions were analysed by mass spectrometry. RESULTS: Protein adsorption started immediately after contact with blood. From the identified proteins, clusters were created which show a similar expression over time. This allows to analyse specifically when which proteins of certain pathways bind on the surface. Further mass spectrometric analyses are ongoing and will be analysed shortly. DISCUSSION: Identification of the time-dependent protein adsorption and -exchange on the surface will provide us with the necessary knowledge to predict beneficial protein compositions over adverse ones for haemocompatibility. Further experiments will then reveal if the new surface modifications are suitable for long-term use of oxygenators. CONCLUSIONS: Manufacturing of new surface modifications after analysing the protein adsorption data will pave the way towards longer use of oxygenators, maybe even for long-term use as part of implantable devices.