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

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

More information

Identifiers

ORCID for Rebecca Band: orcid.org/0000-0001-5403-1708

ORCID for Sean Ewings: orcid.org/0000-0001-7214-4917

ORCID for Jaimie Ellis: orcid.org/0000-0003-0068-3318

ORCID for Ivaylo Vassilev: orcid.org/0000-0002-2206-8247

ORCID for Maria Carmen Portillo: orcid.org/0000-0003-1583-6612

ORCID for Lucy Yardley: orcid.org/0000-0002-3853-883X

ORCID for David Culliford: orcid.org/0000-0003-1663-0253

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