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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
  1. Rebecca Band1,2,3,
  2. Sean Ewings2,
  3. Tara Cheetham-Blake2,3,
  4. Jaimie Ellis2,3,
  5. Katie Breheny4,
  6. Ivaylo Vassilev2,3,
  7. Mari Carmen Portillo2,3,
  8. Lucy Yardley5,6,
  9. Christian Blickem7,
  10. Rebecca Kandiyali8,
  11. David Culliford3,9,
  12. Anne Rogers2,3
  1. 1 Psychology, University of Southampton, Southampton, UK
  2. 2 Health Sciences, University of Southampton, Southampton, UK
  3. 3 NIHR Collaboration for Leadership in Applied Health Research and Care Wessex, NIHR, Wessex, UK
  4. 4 Population Health Sciences, University of Bristol, Bristol, UK
  5. 5 Academic Unit of Psychology, University of Southampton, Southampton, UK
  6. 6 School of Psychological Science, University of Bristol, Bristol, UK
  7. 7 Public Health, Liverpool John Moores University, Liverpool, UK
  8. 8 Centre for Child and Adolescent Health, University of Bristol School of Social and Community Medicine, Bristol, UK
  9. 9 Faculty of Medicine, University of Southampton, Southampton, UK
  1. Correspondence to Rebecca Band; r.j.band{at}soton.ac.uk

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 Project About Loneliness and Social networks (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 Generating Engagement in Network Involvement (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, well-being, 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 well-being). 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 ISRCTN19193075

  • protocol
  • randomised controlled trial
  • social networks
  • social isolation
  • loneliness

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors RB developed the initial idea for the study and obtained funding in collaboration with AR, SE, DC, IV, MCP, LY, RK, CB and the PALS study team. All authors have contributed to the protocol development. RB, TCB, JE and AR have led the trial preparations and development of training materials. IV has lead the development and modification of Genie. SE and DC led the statistical analysis planning, and KB and RK have led the health economics planning. JE, CB and AR have led the qualitative process evaluation planning. RB wrote the initial draft, all subsequent drafts were contributed to by all authors who have approved the final version.

  • Funding This protocol paper summarises independent research funded by the National Institute for Health Research (NIHR) under its Public Health Research programme (Grant Reference Number 16/08/41). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Care.

  • Competing interests None declared.

  • Ethics approval Ethical approval for the PALS study has been obtained from the South Central—Berkshire B ethics committee (reference: 15/SC/0245). All substantial amendments must be approved by the University ethics committee and NHS ethics committee responsible for the trial, in additional to approval by HRA. Investigators are kept up to date with relevant changes via regular management group meetings.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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