gms | German Medical Science

Background/research question: The COVID-19 pandemic is a threat to clinical trials necessitating regular face-to-face meetings, particularly in participants with a high risk of complications. Guidance on how to handle such trials is lacking. The ENTAIER-randomised controlled trial (DRKS00016609) 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 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, which had to be substituted by a telemedicine programme within a short timeframe. The objectives 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.

Methods: We proceeded with four steps:

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A literature review on the quality and feasibility issues of telemedicine in general, and specifically, in exercise training in elderly individuals.

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Participation in two international telemedicine task forces on integrative and mind–body medicine.

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Interviews with study therapists, personnel, and international experts on providing mindful movement exercises and other physiotherapies via live telecommunication technology, and with scientists and patient representatives.

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Final evaluation by the core trial team and subsequent planning and implementation of changes in the trial organisation.

Results: Various tasks and challenges were identified for therapists and patients: for the technical equipment; for the ability to adequately manage the technology and telemedicine intervention; for reservations and concerns; for safety and data protection; and for the study design. Of two major options found to continue the trial in the COVID-19 situation a partial switch to telemedicine was chosen in the form of risk management implemented into the former design.

Conclusion: 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.

Competing interests: None