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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

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

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.

Intervention, Physical health, Serious mental illness, Volunteers
2055-5784
Williams, Julie
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Fairbairn, Elliann
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Mcgrath, Ray
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Bakolis, Ioannis
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Healey, Andy
237101bc-f01c-42dc-b175-582bfbd96de7
Akpan, Ubong
fd56d19b-05c2-4911-b004-78eebd35799f
Mdudu, Isabel
93e7f59b-a6ee-46f1-b0da-029ef7a503c9
Gaughran, Fiona
0239d6e1-a8bc-4c96-b5b4-1dbea0d4b72c
Sadler, Euan
e5891abe-c97b-4e74-b9b3-6d7c43435360
Khadjesari, Zarnie
f381df38-624a-4d29-88d0-68344fa2975b
Lillywhite, Kate
cd8b7e6c-046e-48c5-a1e4-6b50327cf154
Sevdalis, Nick
0910262b-1085-41fa-931c-40b643912854
Williams, Julie
4752662a-f68a-40fd-bb6a-015c53d73d27
Fairbairn, Elliann
7bf77f03-b72e-4ea9-8907-88ca7ab756f3
Mcgrath, Ray
ea352f42-f7db-4587-ae35-d9670ec33d7b
Bakolis, Ioannis
67d883d3-5590-4eab-9422-b722a72c6967
Healey, Andy
237101bc-f01c-42dc-b175-582bfbd96de7
Akpan, Ubong
fd56d19b-05c2-4911-b004-78eebd35799f
Mdudu, Isabel
93e7f59b-a6ee-46f1-b0da-029ef7a503c9
Gaughran, Fiona
0239d6e1-a8bc-4c96-b5b4-1dbea0d4b72c
Sadler, Euan
e5891abe-c97b-4e74-b9b3-6d7c43435360
Khadjesari, Zarnie
f381df38-624a-4d29-88d0-68344fa2975b
Lillywhite, Kate
cd8b7e6c-046e-48c5-a1e4-6b50327cf154
Sevdalis, Nick
0910262b-1085-41fa-931c-40b643912854

Williams, Julie, Fairbairn, Elliann, Mcgrath, Ray, Bakolis, Ioannis, Healey, Andy, Akpan, Ubong, Mdudu, Isabel, Gaughran, Fiona, Sadler, Euan, Khadjesari, Zarnie, Lillywhite, Kate and Sevdalis, Nick (2021) A feasibility hybrid II randomised controlled trial of volunteer ‘Health Champions’ supporting people with serious mental illness manage their physical health: study protocol. Pilot and Feasibility Studies, 7 (1), [116]. (doi:10.1186/s40814-021-00854-8).

Record type: Article

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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Accepted/In Press date: 17 May 2021
e-pub ahead of print date: 31 May 2021
Published date: 31 May 2021
Additional Information: Funding 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.
Keywords: Intervention, Physical health, Serious mental illness, Volunteers

Identifiers

Local EPrints ID: 449551
URI: http://eprints.soton.ac.uk/id/eprint/449551
ISSN: 2055-5784
PURE UUID: 13de8e1b-25f5-4bd0-8161-fc136774965f
ORCID for Euan Sadler: ORCID iD orcid.org/0000-0003-3827-224X

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Date deposited: 07 Jun 2021 16:32
Last modified: 17 Mar 2024 03:56

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Contributors

Author: Julie Williams
Author: Elliann Fairbairn
Author: Ray Mcgrath
Author: Ioannis Bakolis
Author: Andy Healey
Author: Ubong Akpan
Author: Isabel Mdudu
Author: Fiona Gaughran
Author: Euan Sadler ORCID iD
Author: Zarnie Khadjesari
Author: Kate Lillywhite
Author: Nick Sevdalis

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