BMC geriatrics
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Randomized Controlled Trial
Addressing COVID-19 challenges in a randomised controlled trial on exercise interventions in a high-risk population.
The coronavirus disease 2019 (COVID-19) pandemic is a threat to ongoing clinical trials necessitating regular face-to-face, in-person meetings, particularly in participants with a high risk of complications. Guidance on how to handle and safely continue such trials is lacking. Chronically ill elderly individuals require-in addition to protection from infection-regular physical exercise and social contact to remain healthy. Solutions on how to handle these conflicting necessities are needed. The ENTAIER-randomised controlled trial was investigating the influence of mindful movements on fall risk, fear of falling, mobility, balance, life quality, and other outcomes. The study population was planned to comprise of 550 chronically ill elderly individuals with a high risk of falling. The movements were regularly performed in coached groups over 6 months. After the trial began, COVID-19 lockdowns stopped all in-person meetings, and it was expected that the limitations of this pandemic would continue for a long term. Therefore, the exercise programme, which involved complex movements and was typically conducted face-to-face in groups, had to be substituted by a telemedicine programme within a short timeframe. The objectives, therefore, were to identify challenges and tasks that could to be resolved and steps that could to be taken to achieve high-quality, efficacy, safety, and enable human encounter and motivation. ⋯ The management of an ongoing clinical trial in a national or international crisis with a minimum of available time and extra financial resources, alongside with two checklists on steps and procedures for trial continuation and telemedicine implementation, may be informative for other researchers or healthcare providers faced with similar challenges and making similar decisions in the current situation or similar future scenarios. TRAIL REGISTRATION: www.drks.de . DRKS00016609. Registered July 30, 2019.
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Randomized Controlled Trial
Effects of an interprofessional Quality Circle-Deprescribing Module (QC-DeMo) in Swiss nursing homes: a randomised controlled trial.
Potentially inappropriate medications (PIMs) are common among nursing homes (NH) residents, as is polypharmacy. Deprescribing has emerged in the past decade as a safe and effective way to reduce the use of PIMs and improve patient outcomes. However, effective deprescribing interventions are expensive, as they require specialised staff and a great amount of time for each resident. The Quality Circle Deprescribing Module (QC-DeMo) intervention was designed to be less resource-intensive than medication reviews, the current deprescribing gold standard. It consists of a QC session in which physicians, nurses, and pharmacists define a local deprescribing consensus for specific PIMs classes, which is then implemented in the NH. The intervention was trialled in a RCT, with the NH as unit of analysis. ⋯ The QC-DeMo intervention can reduce the use of some PIM classes, and could usefully complement other deprescribing interventions.