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Article History

Received: 6 July 2018

Accepted: 21 September 2018

First Online: 19 October 2018

Ethics approval and consent to participate

: The design of this process evaluation is included within the ethics application and overall protocol for the RCT []. Ethical approval for the trial was given by the Research Ethics Committee England, Wales and Northern Ireland (14/WA/1081) and Scotland (14/SS/1046). Participants who meet the inclusion criteria and verbally agree to participate are asked to sign a consent form. If a participant has difficulty completing the consent form due to visual impairment or frailty, but is capable of informed consent, a witness signature is sought from a next of kin or medical professional not working within the trial team to confirm the consent process was appropriately performed. We are recruiting adult participants with cognitive impairment/dementia who are unable to consent for themselves. We consider that this is necessary because, if recruitment is restricted to patients with capacity, such a restriction would lead to an unrepresentative study sample. The consent process takes into account the implications of the Mental Capacity Act (2005) in England, Wales and Northern Ireland and the Adults with Incapacity Act (2000) in Scotland. A relative, friend or Independent Mental Capacity Advocate is involved in making a decision in the best interests of individuals if they do not have capacity to give consent. If necessary, this consultee consent is taken verbally over the phone and the paperwork sent to the consultee to be signed to record consent. We reassess capacity at follow-up visits and re-consent a participant if their capacity changes between baseline and follow-up. Participants, or their representatives, are asked to sign and date the latest approved version of the Informed Consent Form before any trial-specific procedures are performed. The trial manager ensures that all sites are aware of any amendments.

: Not applicable.

: The authors declare that they have no competing interests.

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