Tropea, Joanne http://orcid.org/0000-0002-5799-3977
Johnson, Christina E.
Nestel, Debra
Paul, Sanjoy K.
Brand, Caroline A.
Hutchinson, Anastasia F.
Bicknell, Ross
Lim, Wen Kwang
Funding for this research was provided by:
Department of Health, Australian Government (Dementia and Aged Care Services Grant Opportunity 1)
Article History
Received: 2 March 2019
Accepted: 2 October 2019
First Online: 23 October 2019
Ethics approval and consent to participate
: Ethics approval was received by the Melbourne Health Human Research and Ethics Committee (HREC/17/MH/336). Consent for participation in IMPETUS-D and the associated evaluation will be at the facility level. Individual written consent from RACF staff who participate in the research will be sought. Consent from individuals living in the residential care facilities has been waived, as it was deemed unnecessary by the Melbourne Health Human Research and Ethics Committee.<i>Patient safety.</i>The number of deaths and hospital transfers will be monitored in the control and intervention groups. The plain language statements include contact details of the principal investigator, project coordinator and the ethics committee that participants can contact in the event of a complaint or concern about the project. Any reported issues, adverse events and other unintended effects of the trial intervention will be collected and reported to the IMPETUS-D Project Working and Advisory Group and the IMPETUS-D Steering Committee.<i>Study management and oversight.</i>This study is managed by the IMPETUS-D Project Working and Advisory Group, consisting of the principal investigator, co-investigators and representation from the aged care home provider. The IMPETUS-D Steering Committee with members from stakeholder groups provides additional governance oversight for the study monitoring.Written 6-monthly progress reports and meetings with the funding body will be take place throughout the project timeline.
: Not applicable.
: SKP has acted as a consultant and/or speaker for Novartis, GI Dynamics, Roche, AstraZeneca, Guangzhou Zhongyi Pharmaceutical and Amylin Pharmaceuticals LLC. He has received grants in support of investigator and investigator initiated clinical studies from Merck, Novo Nordisk, AstraZeneca, Hospira, Amylin Pharmaceuticals, Sanofi-Avensis and Pfizer.All other authors do not have any competing interests to declare.