Munro, Kevin J.
Armitage, Christopher
Elliott, Rachel
Saunders, Gabrielle H.
Haydock, Rebecca
Leverton, Ted
Juszczak, Edmund
Oliver, Francesca
Partlett, Christopher
Rick, Caroline
Schilder, Anne
Wild, Jane
Wilson, Paul
Sereda, Magdalena
Loughran, Michael
Holt, Grace
Gill, Bethany https://orcid.org/0009-0008-9863-1690
Funding for this research was provided by:
Health Technology Assessment Programme (NIHR131159)
Article History
Received: 19 December 2024
Accepted: 3 October 2025
First Online: 5 November 2025
Declarations
:
: Ethics approval was granted by the London—Chelsea Research Ethics Committee on 21 st December 2022 (Ref: 22/LO/0836). Substantial Amendment 01 was approved on 26th May 2023, which included the addition of details for the process evaluation for FAMOUS; changing the name of the intervention arm to ‘Structured Care’; detailing the script for the patient video; a change to the HHIE questionnaire following updated published guidance; and minor administrative changes to the patient information sheet and model non-commercial agreement. Substantial Amendment 02 was approved on 10th April 2024, which included the rewording of the participant consent form to improve participant self-completion, and introduced the option to re-consent participants as required. Substantial Amendment 03 was approved on 14th April 2025, which includes changes to the 12-month questionnaire booklet and text message reminders, with an aim to improve participant retention.
: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are available from the corresponding author on request.
: The authors and PIs declare that they have no competing interests.