Addressing COVID-19 Challenges in a Randomised Controlled Trial on Exercise Interventions in a High-Risk Population

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.

Implementation of the RECOVARI Trial on Effectiveness and Safety of Rhythmic Embrocations During the COVID19 Pandemic

Methods: The following tools were used: 1. Division of the project into phases: Initialization, Definition, Planning, Implementation, Control and Closure. 2. SWOT analysis to categorize the project into Strengths, Weaknesses, Opportunities, Threats. 3. Evaluation of target groups and stakeholders. 4. Definition of objectives according to the SMART model. 5. Breakdown of the project into milestones. 6. Risk analysis. 7. During the implementation phase of the project, further project management tools were used, such as controlling, quality management and error management. Results: The tools of project management could be related to the planning and implementation of the RECOVARI study and supported the process significantly. Despite the tense situation in nursing, the RECOVARI study was able to find its place on the wards. Stakeholder feedback has been consistently positive. The planning and implementation was successful. Background: The RECOVARI study investigates in a randomized controlled trial the effect of rhythmic embrocations (RhE) on stress after surgery in 60 patients with colorectal carcinoma. Nowadays, the daily nursing routine in acute care hospitals in Germany faces great challenges. Increasing workload and the shortage of specialists are major problems. Under the situation of the COVID-19 pandemic, both developments have become more acute. Numerous, changing legal requirements for infection control had to be integrated into everyday nursing care. Sickness and care absences had to be compensated for. Integrating an intervention care study into everyday inpatient care in this pandemic situation required planning elements that can be adapted at any time. These can be found in project management, as this planning method includes times of crisis due to consideration of risks. Conclusion: The following “4 C's” have emerged as the fundamental tasks for this implemengation: • Communication with target groups and stakeholders • Cooperation with the stakeholders • Coordination of the study relevant measures • Control of the processes and project management.

Addressing COVID-19 challenges in a randomised controlled trial on exercise interventions in a high-risk population.

BACKGROUND: 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. METHODS: We proceeded with four steps: 1) A literature review on the quality and feasibility issues of telemedicine in general, and specifically, in exercise training in elderly individuals. 2) Participation in two international telemedicine task forces on integrative medicine, particularly, mind-body medicine. 3) Interviews with study therapists, (for practical purposes, eurythmy therapists and Tai Chi teachers are summarized here as therapists) personnel, and international experts on providing mindful movement exercises and other physiotherapies via live telecommunication technology, and with scientists and patient representatives. 4) 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 the technical equipment for therapists and patients; for the ability of therapists and trial participants to adequately manage the technology and telemedicine intervention; the reservations and concerns about the technology among therapists and participants; 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. CONCLUSIONS: 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.