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Global Advances in Health and Medicine ; 11:65, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-1916571

RESUMEN

Methods: We proceeded as follows: 1) A literature review on the quality and feasibility of telemedicine in general, and specifically, in exercise training in elderly individuals. 2) Participation in two international telemedicine task forces. 3) Interviews with study therapists, personnel, international experts, scientists and patient representatives. 4) Evaluation by the trial team and planning and implementation of changes in the trial organisation. Results: Identified topics were: technical equipment;ability to adequately manage the technology and telemedicine intervention;reservations and concerns about the technology;safety and data protection in using the technology;and study design. The two major options found on how to continue the trial in the COVID-19 situation were a complete switch to telemedicine and a partial switch in the form of risk management implemented into the former design. Background: The coronavirus disease 2019 pandemic is a threat to ongoing trials with regular in-person meetings, particularly in high risk populations. Guidance on how to handle and safely continue such trials is lacking. The ENTAIER trial was investigating the influence of mindful movements on fall risk and other outcomes in 550 chronically ill elderly individuals. The movements were regularly performed in groups over 6 months. After the trial began, lockdowns stopped all in-person meetings. The exercise programme had to be substituted by a telemedicine programme. The objectives, therefore, were to identify challenges, tasks and procedures to achieve high-quality, efficacy, safety, and enable human encounter and motivation. Conclusion: The management of an ongoing clinical trial in a national or international crisis with a minimum of 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.

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