The Project About Loneliness and Social networks (PALS)

ISRCTN ISRCTN19193075
DOI https://doi.org/10.1186/ISRCTN19193075
IRAS number 232890
Secondary identifying numbers CPMS 38368
Submission date
01/10/2018
Registration date
02/10/2018
Last edited
10/03/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Around 30% of the UK population experience loneliness. Older people and those with long-term health problems are far more likely to be lonely and isolated than those in good health. Feeling lonely and isolated also has a negative impact on a person’s emotional and physical health, and costs the NHS money due to more medical appointments and hospital visits. Evidence has shown that connecting with community resources can help protect against loneliness for those most at risk. This study will test if it is possible to reduce the negative impacts of loneliness and social isolation by focussing on the support networks that people have around them. GENIE is an online tool that allows people to map their social networks (which may include friends, family, groups, pets, daily activities). It also asks about people’s preferred interests and activities and provides links to local activities which match these. This study will explore how GENIE can be used to improve social networks using existing local community groups and resources, to provide emotional and physical health benefits to participants.

Who can participate?
Isolated and lonely adults in two regions in the North and South of England (centred around Southampton and Liverpool)

What does the study involve?
Participants are randomly allocated to two groups. One group uses GENIE. With the help of a facilitator, people using GENIE are asked to think about the role of people around them, and how their networks might be improved, by including other people already around them who they did not initially think of, or from new connections to community activities. By thinking about their whole network, people are able to build on existing connections and that linking to local activities and groups of interest gives people the opportunity to meet others with similar interests and improves the sense of connection to the local community. The other group carries on as usual but can use GENIE with a facilitator, if they want to, after 6 months once the study has finished. A small number of people are selected for interview to understand their experiences of loneliness and isolation, and how this might have changed because of the study.

What are the possible benefits and risks of participating?
The study will help us to understand how, where and why people are lonely within our local communities particularly those living in disadvantaged situations (e.g. poor housing or with low incomes). It will show how best to use existing community groups, resources and organisations to access and help those most at risk. As GENIE is distinct from other approaches, such as befriending schemes, the study will help us understand how reducing isolation and feelings of loneliness happens after using GENIE. The researchers have been working with different groups across the two cities, including the NHS, housing associations, fire service, care and support organisations, health and community groups, to help target all relevant activities and services. GENIE will be delivered by people who work for these organisations. The Campaign to End Loneliness are also collaborating with the study team. By including a wide range of stakeholders the researchers hope to share their findings more broadly and innovatively than within an academic context and if effective, they will be able to provide evidence for policy makers.

Where is the study run from?
1. University of Southampton (UK)
2. Liverpool John Moores University (UK)

When is the study starting and how long is it expected to run for?
March 2018 to June 2022 (updated 09/02/2021, previously: February 2021)

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Dr Rebecca Band
2. Kate Rodger

Contact information

Dr Rebecca Band
Public

PALS Trial Office
Faculty of Health Sciences
67/ E3011
Nightingale Building
University of Southampton
Highfield Campus
Southampton
SO17 1BJ
United Kingdom

Email r.j.band@swansea.ac.uk
Ms Kate Rodger
Scientific

PALS Trial Office
Faculty of Health Sciences
67/ E3011
Nightingale Building
University of Southampton
Highfield Campus
Southampton
SO17 1BJ
United Kingdom

Email k.rodger@soton.ac.uk

Study information

Study designRandomized; Both; Design type: Treatment, Psychological & Behavioural, Qualitative
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Community
Study typeQuality of life
Participant information sheet ISRCTN19193075_PIS_V4.0_11Jun2018.pdf
Scientific titleThe Project About Loneliness and Social networks (PALS): a cluster-randomised trial comparing GENIE with usual care for socially-isolated people
Study acronymPALS
Study hypothesisThe aim of the study is to assess the clinical and cost-effectiveness of the GENIE intervention compared to usual care within a community setting among at-risk populations, and to understand the implementation of GENIE in the context of different organisations who work in this environment.
Ethics approval(s)1. South Central - Berkshire Research Ethics Committee, 27/06/2018, ref: 18/SC/0245
2. University of Southampton, Faculty of Health Sciences Ethics Committee, 06/03/2018, Ethics ID: 31638
ConditionSocial exclusion
InterventionThe Generating Engagement in Network Involvement (GENIE) intervention is a facilitated web-based social networking tool designed to overcome the barriers to social participation, by identifying where social contact is lacking, focussing attention on valued activities and identifying potential access to social and health enhancing resources. In this study we will conduct a pragmatic, cluster-randomised controlled trial comparing participants receiving the GENIE intervention to a wait-list control group, with an internal pilot and embedded qualitative process evaluation.

The PALS study will comprise:
1. Internal pilot trial: due to potential recruitment difficulties there will be an internal pilot to confirm the acceptability and feasibility of the full trial protocol and study procedures. Recruitment rates will be assessed against stop/go criteria at 12 months into the recruitment period
2. Randomised controlled trial: A full randomised controlled trial will compare the GENIE intervention to a wait-list control group for individuals who are isolated or lonely. A total of 394 participants will be recruited, 197 per arm. GENIE is initially introduced via a guided discussion with a trained peer (or another individual – referred to as facilitators); this takes 30 to 40 minutes to deliver and has three stages: social network mapping (creating a visual map of their current support network), tailoring of preferences (answering 13 questions designed to help people focus on their interest, support, health and wellness needs and enjoyable activities), linking users to valued resources and activities (receiving tailored access to local resources based on personal preferences)
3. Health economic modelling and a qualitative process analysis study will also be embedded into the PALS study
Intervention typeBehavioural
Primary outcome measureMental health is measured using the SF-12 Mental Health composite scale score at baseline, 3 months and 6 months
Secondary outcome measures1. Physical health is measured using the SF-12 Physical Health composite scale score at baseline, 3 months and 6 months
2. Loneliness is measured using the De Jong Scale and the Campaign to end loneliness scale at baseline, 3 months and 6 months
3. Beliefs about loneliness are measured using a modified version of the B-IPQ at baseline, 3 months and 6 months
4. Social isolation is measured using the Duke Social Support index and social support is measured using the SPA at baseline, 3 months and 6 months
5. Collective efficacy is measured using the CENS questionnaire at baseline, 3 months and 6 months
6. Wellbeing is measured using the Warwick Edinburgh Mental Well-being scale and quality of life measured using the ICECAP-A at baseline, 3 months and 6 months
7. Healthcare utilisation is measured using the EUWISE questionnaire and health utilities will be valued via application of the SF-6D algorithm to responses on the SF12 at baseline, 3 months and 6 months
8. Social network composition measured using GENIE at baseline and 3 months for intervention participants only
Overall study start date01/03/2018
Overall study end date30/06/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsParticipants: 394 (197 per arm; 12 per facilitator)
Total final enrolment469
Participant inclusion criteria1. Aged over 18 years
2. A socially isolated person as one for whom there is an absence of social contacts or community involvement, or lack of access to services
Participant exclusion criteriaCurrent exclusion criteria as of 11/01/2022:
1. Currently hospitalised (i.e. not self-managing within a community setting)
2. Terminal disease or any acute exacerbation of the condition which impacts upon their ability to take part
3. Lacking sufficient capacity to consent or take part in the study
4. Having had previously used the GENIE intervention

Previous exclusion criteria:
1. Currently hospitalised (i.e. not self-managing within a community setting)
2. Terminal disease or any acute exacerbation of the condition which impacts upon their ability to take part
3. Lacking sufficient capacity to consent or take part in the study
4. Household member enrolled in the study (to avoid bias)
5. Having had previously used the GENIE intervention
Recruitment start date05/10/2018
Recruitment end date17/11/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

University of Southampton
Southampton
SO17 1BJ
United Kingdom
Liverpool John Moores University
Liverpool
L3 5UA
United Kingdom

Sponsor information

University of Southampton
University/education

Head of IP, Contracts & Policy
Southampton
SO17 1BJ
England
United Kingdom

Phone +44 (0)2380595058
Email rgoinfo@soton.ac.uk
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Government

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/08/41

No information available

Results and Publications

Intention to publish date30/06/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThe study protocol is due to be submitted for publication asap. No other additional documentation is currently available. Planned publication of the study results in a high-impact peer reviewed journal ~2021.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V4.0 11/06/2018 02/10/2018 No Yes
Protocol article protocol 18/08/2019 02/09/2020 Yes No
Interim results article data gathered before March 2020 26/04/2022 27/04/2022 Yes No
HRA research summary 28/06/2023 No No
Other publications Qualitative study 19/05/2020 17/11/2023 Yes No
Results article 01/03/2025 10/03/2025 Yes No

Additional files

ISRCTN19193075_PIS_V4.0_11Jun2018.pdf
Uploaded 02/10/2018

Editorial Notes

10/03/2025: Publication reference added.
30/07/2024: The IRAS number was added.
29/07/2024: A contact was updated.
17/11/2023: Publication reference added.
27/04/2022: Publication reference added.
11/01/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2022 to 17/11/2021.
2. The total final enrolment number was added.
3. The exclusion criteria were updated.
09/02/2021: The following changes were made to the trial record:
1. The recruitment resumed.
2. The recruitment end date was changed from 31/03/2020 to 01/06/2022.
3. The overall end date was changed from 28/02/2021 to 30/06/2022.
4. The plain English summary was updated to reflect these changes.
5. The intention to publish date was changed from 28/02/2021 to 30/06/2024.
02/09/2020: Publication reference added.
09/07/2020: The trial contact details have been made publicly visible.
07/04/2020: Due to current public health guidance, recruitment for this study has been paused.
25/03/2019: The condition has been changed from "Specialty: Public Health, Primary sub-specialty: Public Health; Health Category: Generic health relevance" to "Social exclusion" following a request from the NIHR. The condition category has been changed from "Not Applicable' to 'Mental and Behavioural Disorders'.
08/10/2018: The recruitment start date was changed from 01/06/2018 to 05/10/2018.
02/10/2018: The participant information sheet has been uploaded.