Zheng, David http://orcid.org/0000-0003-4725-2638
Rose, Louise
Borgundvaag, Bjug
McLeod, Shelley L.
Melady, Donald
Mohindra, Rohit
Sinha, Samir
Wesson, Virginia
Wiesenfeld, Lesley
Kolker, Sabrina
Kiss, Alex
Lowthian, Judy A.
Lee, Jacques S.
Article History
Received: 3 October 2023
Accepted: 18 June 2024
First Online: 28 June 2024
Declarations
:
: Research Ethics Board (REB) approval from Mount Sinai Hospital REB (MSH REB: 21–0074-E) as well as the North York General Hospital REB has been received for obtaining verbal consent from patients for the main trial. REB approval has been received to amend the consent form to allow the additional measures contained in this protocol for waitlist control patients only. Participants can terminate their participation in the study at any time without influencing their ongoing care at the participating hospital. The interventions themselves present a minimal risk to participants and potential risks such as countertransference and sharing misinformation are outlined in the mandatory training sessions of both the peer support and intergenerational interventions. Given that this is a minimal-risk social intervention and not a pharmaceutical trial, adverse events are not anticipated. However, participants or their next of kin who may have concerns in any cases of harm or questions about privacy in the intervention will be encouraged to contact the trial coordinator and all reported adverse events will be recorded. Similar to the approach used in the proof-of-concept trial, volunteers are instructed to relay any concerns regarding the health of a participant to an emergency physician co-investigator [].
: The outcomes of this trial will be disseminated in ClinicalTrials.gov and in a peer-reviewed journal. Full protocols, statistical code, and datasets collected in the study are not publicly available. The results of the study can also be shared with any interested study participants on reasonable request to the principal investigator.
: Not applicable.
: The authors declare that they have no competing interests.