Preventing Respiratory Viral Illness Invisibly (PRiVII): protocol for a pragmatic cluster randomized trial evaluating far-UVC light devices in long-term care facilities to reduce infections.
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Full Title: Trials
Abbreviation: Trials
Country: Unknown
Publisher: Unknown
Language: N/A
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"Declarations Ethics approval and consent to participate {24}The protocol has been approved by the Nova Scotia Health Research Ethics Board. An alteration of consent for the study intervention was obtained because the intervention is minimal risk, and it is a cluster-level intervention, making it infeasible for individual residents to decline exposure. Consent for data collection is obtained from participating residents if they have documented capacity to make clinical decisions, according to their medical records. If their medical records indicate that they lack capacity to make clinical decisions, surrogate consent is obtained from the SDM documented in their medical records. The informed consent form can be found in Additional File 2. Competing interests {28}Kenneth Rockwood has asserted copyright of the Clinical Frailty Scale through Dalhousie University’s Industry, Liaison, and Innovation Office, which has been licensed to Enanta Pharmaceuticals, Synairgen Research, Faraday Pharmaceuticals, KCR S. A., Icosavax, BioAge Labs, Biotest AG, AstraZeneca UK Limited, and Qu Biologics. He has also asserted copyright (with Dr. Olga Theou) for the Pictorial Fit-Frail Scale, which has been licensed to Congenica; use of both the Clinical Frailty Scale and Pictorial Fit-Frail Scale is free for education, research, and nonprofit health care with completion of a permission agreement stipulating users will not change, charge for, or commercialize the scales. Proceeds from license fees are donated to Dalhousie University. He reports personal fees from the Burnaby Division Family Practice, United Arab Emirates University, Singapore National Research Foundation, McMaster University, Chinese Medical Association, Wake Forest University Medical School, University of Omaha, and Atria Institute. He chaired the data safety monitoring board for the ADMET-II clinical trial. He is co-founder of Ardea Outcomes, which (DGI Clinical until 2021) in the last 3 years has contracts with pharmaceutical and device manufacturers (Hollister, INmune, Novartis, Takeda) on individualized outcome measurement, but not on frailty. In 2020, on behalf of Ardea Outcomes, he attended an advisory board meeting with Nutricia on dementia. Until December 31, 2023, he was Associate Director of the Canadian Consortium on Neurodegeneration in Aging. Since January 2022, he is Special Advisor to the President of Cape Breton University on frailty and aging (both are unpaid positions.) All other co-authors declare that they have no competing interests. Competing interests {28} Kenneth Rockwood has asserted copyright of the Clinical Frailty Scale through Dalhousie University’s Industry, Liaison, and Innovation Office, which has been licensed to Enanta Pharmaceuticals, Synairgen Research, Faraday Pharmaceuticals, KCR S. A., Icosavax, BioAge Labs, Biotest AG, AstraZeneca UK Limited, and Qu Biologics. He has also asserted copyright (with Dr. Olga Theou) for the Pictorial Fit-Frail Scale, which has been licensed to Congenica; use of both the Clinical Frailty Scale and Pictorial Fit-Frail Scale is free for education, research, and nonprofit health care with completion of a permission agreement stipulating users will not change, charge for, or commercialize the scales. Proceeds from license fees are donated to Dalhousie University. He reports personal fees from the Burnaby Division Family Practice, United Arab Emirates University, Singapore National Research Foundation, McMaster University, Chinese Medical Association, Wake Forest University Medical School, University of Omaha, and Atria Institute. He chaired the data safety monitoring board for the ADMET-II clinical trial. He is co-founder of Ardea Outcomes, which (DGI Clinical until 2021) in the last 3 years has contracts with pharmaceutical and device manufacturers (Hollister, INmune, Novartis, Takeda) on individualized outcome measurement, but not on frailty. In 2020, on behalf of Ardea Outcomes, he attended an advisory board meeting with Nutricia on dementia. Until December 31, 2023, he was Associate Director of the Canadian Consortium on Neurodegeneration in Aging. Since January 2022, he is Special Advisor to the President of Cape Breton University on frailty and aging (both are unpaid positions.) All other co-authors declare that they have no competing interests."
"Funding {4} Funding was obtained from the following grants: (1) 2022-2401 Special Initiatives Award (Research Nova Scotia) and (2) 022-2409 2022-23 Intentional Initiative Award (Research Nova Scotia). The funding agency had no role in designing the study. It has no role in the collection, analysis, or interpretation of data. And it has no role in the writing of manuscripts related to the trial."
"Trial registration ClinicalTrials.gov NCT05084898. October 20, 2021."
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