Pilot and feasibility studies
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Pilot Feasibility Stud · Mar 2021
Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial.
Intensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomised controlled trial (RCT), primarily to evaluate the feasibility and additionally the potential efficacy. ⋯ The PINA study will determine feasibility and potential efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multi-centre RCT.
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Pilot Feasibility Stud · Mar 2021
Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2).
The outbreak of SARS-CoV-2 (coronavirus, COVID-19), declared a pandemic by the World Health Organization (WHO), is a global health problem with ever-increasing attributed deaths. Vital sign trends are routinely used to monitor patients with changes in these parameters often preceding an adverse event. Wearable sensors can measure vital signs continuously (e.g. heart rate, respiratory rate, temperature) remotely and can be utilised to recognise early clinical deterioration. ⋯ This trial should prove the feasibility of a rapidly implemented model of healthcare delivery through remote monitoring during a global pandemic at a hotel, acting as an extension to a healthcare trust. Potential benefits would include reducing infection risk of COVID-19 to healthcare staff, with earlier recognition of clinical deterioration through ambulatory, continuous, remote monitoring using a discrete wearable sensor. We hope our results can power future, robust randomised trials.