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Study protocol for ‘The Project About Loneliness and Social networks (PALS)’: a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially-isolated people

Study protocol for ‘The Project About Loneliness and Social networks (PALS)’: a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially-isolated people
Study protocol for ‘The Project About Loneliness and Social networks (PALS)’: a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially-isolated people
Introduction:
Loneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the PALS study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Genie in the context of different organisations.

Methods and analysis:
The PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness; social isolation; wellbeing; physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability wellbeing). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context.

Ethics and dissemination:
This study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners.

Trial registration number: ISRCTN 19193075
2044-6055
1-9
Band, Rebecca
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Ewings, Sean
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Cheetham-Blake, Tara
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Ellis, Jaimie
eb60a3a4-281b-4895-9583-4d5cf1e65b4d
Breheny, Katie
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Vassilev, Ivaylo
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Portillo, Maria Carmen
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Yardley, Lucy
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Blickem, Christian
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Kandiyali, Rebecca
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Culliford, David
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Rogers, Anne
105eeebc-1899-4850-950e-385a51738eb7
Band, Rebecca
be8901bb-bb1b-4131-8e19-c1d4a3bdfb8d
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Cheetham-Blake, Tara
99ea7608-7d19-4e78-bd98-5ca3ca1c46f1
Ellis, Jaimie
eb60a3a4-281b-4895-9583-4d5cf1e65b4d
Breheny, Katie
9510c7c7-836e-4935-bf00-6d50a98d35d4
Vassilev, Ivaylo
d76a5531-4ddc-4eb2-909b-a2a1068f05f3
Portillo, Maria Carmen
f913b5c5-b949-48f2-b1d0-eb7505484d5c
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Blickem, Christian
cc3228ac-f56e-4dca-9aae-cbb6bfac4fb3
Kandiyali, Rebecca
35f03c2f-050f-445c-8261-04fdb2316e2a
Culliford, David
25511573-74d3-422a-b0ee-dfe60f80df87
Rogers, Anne
105eeebc-1899-4850-950e-385a51738eb7

Band, Rebecca, Ewings, Sean, Cheetham-Blake, Tara, Ellis, Jaimie, Breheny, Katie, Vassilev, Ivaylo, Portillo, Maria Carmen, Yardley, Lucy, Blickem, Christian, Kandiyali, Rebecca, Culliford, David and Rogers, Anne (2019) Study protocol for ‘The Project About Loneliness and Social networks (PALS)’: a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially-isolated people. BMJ Open, 9 (8), 1-9, [e028718]. (doi:10.1136/bmjopen-2018-028718).

Record type: Article

Abstract

Introduction:
Loneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the PALS study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Genie in the context of different organisations.

Methods and analysis:
The PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness; social isolation; wellbeing; physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability wellbeing). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context.

Ethics and dissemination:
This study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners.

Trial registration number: ISRCTN 19193075

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More information

Accepted/In Press date: 17 June 2019
e-pub ahead of print date: 18 August 2019
Published date: 18 August 2019

Identifiers

Local EPrints ID: 433503
URI: http://eprints.soton.ac.uk/id/eprint/433503
ISSN: 2044-6055
PURE UUID: a195a087-e0ee-4042-b007-1e1659aa0609
ORCID for Rebecca Band: ORCID iD orcid.org/0000-0001-5403-1708
ORCID for Sean Ewings: ORCID iD orcid.org/0000-0001-7214-4917
ORCID for Jaimie Ellis: ORCID iD orcid.org/0000-0003-0068-3318
ORCID for Maria Carmen Portillo: ORCID iD orcid.org/0000-0003-1583-6612
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for David Culliford: ORCID iD orcid.org/0000-0003-1663-0253

Catalogue record

Date deposited: 23 Aug 2019 16:30
Last modified: 15 Sep 2021 02:04

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Contributors

Author: Rebecca Band ORCID iD
Author: Sean Ewings ORCID iD
Author: Tara Cheetham-Blake
Author: Jaimie Ellis ORCID iD
Author: Katie Breheny
Author: Ivaylo Vassilev
Author: Lucy Yardley ORCID iD
Author: Christian Blickem
Author: Rebecca Kandiyali
Author: David Culliford ORCID iD
Author: Anne Rogers

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