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A feasibility hybrid II randomised controlled trial of volunteer 'Health Champions' supporting people with serious mental illness manage their physical health: study protocol

Research output: Contribution to journalArticlepeer-review

Julie Williams, Elliann Fairbairn, Ray McGrath, Ioannis Bakolis, Andy Healey, Ubong Akpan, Isabel Mdudu, Fiona Gaughran, Euan Sadler, Zarnie Khadjesari, Kate Lillywhite, Nick Sevdalis

Original languageEnglish
Article number116
Pages (from-to)116
JournalPilot and Feasibility Studies
Volume7
Issue number1
DOIs
Published31 May 2021

Bibliographical note

Funding Information: Thank you to the KHP Mind and Body Expert Advisory Group, SLaM Patient Advisory Group and all those who took part in our Theory of Change workshops for all their valuable input. Thank you to Mary Robson who facilitated our Theory of Change workshops so thoughtfully. Thank you to Kia-Chong Chua for help with randomisation. Funding Information: The intervention was developed as part of a larger ‘Integrated Mental and Physical Health Systems’ (IMPHS) Programme funded by the Maudsley Charity and involving SLaM service users and providers. The initial conceptualisation of the intervention came from discussion between the Maudsley Charity, the SLaM Volunteer Manager and the IMPHS project scientists. SLaM volunteers already support people in a variety of ways including befriending and the scope to use volunteers to support physical health was developed into an idea for an intervention. Advice was sought from the King’s Health Partners (KHP) Mind and Body Programme Expert Advisory Group and the SLaM Serious Mental Illness Service User Group as part of the initial development of the Health Champions project. Funding Information: The research was funded by the Maudsley Charity. NS, IB, AH and FG’s research is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King’s College Hospital NHS Foundation Trust. FG and IB are in part supported by the National Institute for Health Research’s (NIHR) Biomedical Research Centre at South London. FG is in part supported by Maudsley NHS Foundation Trust and King’s College London, the Maudsley Charity and the National Institute for Health Research (NIHR) Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. NS and AH are members of King’s Improvement Science, which offers co-funding to the NIHR ARC South London and comprises a specialist team of improvement scientists and senior researchers based at King’s College London. Its work is funded by King’s Health Partners (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, King’s College London and South London and Maudsley NHS Foundation Trust), Guy’s and St Thomas’ Charity and the Maudsley Charity. This is a summary of research supported by the National Institute for Health Research (NIHR) Applied Research Collaboration East of England. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

BACKGROUND: People with serious mental illnesses (SMI) such as schizophrenia often also have physical health illnesses and interventions are needed to address the resultant multimorbidity and reduced life expectancy. Research has shown that volunteers can support people with SMI. This protocol describes a feasibility randomised controlled trial (RCT) of a novel intervention involving volunteer 'Health Champions' supporting people with SMI to manage and improve their physical health.

METHODS: This is a feasibility hybrid II randomised effectiveness-implementation controlled trial. The intervention involves training volunteers to be 'Health Champions' to support individual people with SMI using mental health services. This face-to-face or remote support will take place weekly and last for up to 9 months following initial introduction. This study will recruit 120 participants to compare Health Champions to treatment as usual for people with SMI using secondary community mental health services in South London, UK. We will measure the clinical and cost effectiveness including quality of life. We will measure the implementation outcomes of acceptability, feasibility, appropriateness, fidelity, barriers and enablers, unintended consequences, adoption and sustainability.

DISCUSSION: There is a need for interventions to support people with SMI with their physical health. If this feasibility trial is successful, a definitive trial will follow to fully evaluate the clinical, cost and implementation effectiveness of Health Champions supporting people with SMI.

TRIAL REGISTRATION: ClinicalTrials.gov, registration no: NCT04124744 .

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