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Article History

Received: 22 February 2019

Accepted: 17 July 2019

First Online: 29 July 2019

Ethics approval and consent to participate

: The trial has been registered prospectively with the Australian New Zealand Clinical Trial Registry and approved by the Sydney Local Health District Human Research Ethics Committee – Concord Repatriation General Hospital (HREC/18/CRGH/11). All participants in the trial (clients, carers, clinicians, service providers) provide written consent as per ethical approval and will be provided with a summary of the study findings at the conclusion of the study. The carer’s capacity to participate in the study is initially assessed during the screening phone call, which requires an in-depth discussion around the client’s eligibility, as well as the carer’s, for the study participation, by a clinical researcher who is highly experienced in working with cognitively impaired clients and carers. For clients with dementia and their carer, their capacity to consent is confirmed by the clinical assessor who verifies the client has understood what they consent to during the face-to-face conversation on the day of the baseline assessment, prior to commencement of any study assessments. The assessor will ask both the client and the carer to explain in their words what they believe they are consenting to, in order to establish that they have a reasonable understanding of their involvement in the study. Written consent is obtained from both the client and the carer individually. Protocol amendments will be approved by the HREC before they are implemented, except when the amendment is required in order to protect the subject’s safety, in which case ethics approval can be made retrospectively.

: No individual person’s data is included in the manuscript.

: The authors declare that they have no competing interests.