PALS

Trial Name

PALS - The Project About Loneliness and Social networks: a cluster-randomised trial comparing GENIE with usual care for socially-isolated people

Description

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. The 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. The 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.

Objectives

Primary Objective:

• To determine the effect of GENIE compared to usual care on mental health at three and six months.

Secondary Objectives:

• To assess the feasibility of running the study based on recruitment and retention during an internal pilot phase.
• To determine the effect of GENIE compared to usual care on loneliness, social isolation, physical health, engagement, depression, anxiety, self-efficacy and quality of life.
• To establish whether the use of GENIE within a community setting is cost-effective.
• To explore the experiences of using GENIE, how the intervention impacts on loneliness and isolation, and the mechanisms by which participants enact change.
• To explore environmental and organisational factors that impact the integration and scalability of GENIE in local and organisational settings.

Design

This study is a pragmatic, cluster-randomised controlled trial  comparing participants receiving the GENIE intervention to a wait-list control group, with an internal pilot and embedded process evaluation. The PALS trial will comprise:

• Internal pilot trial: due to potential recruitment difficulties we will include 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.
• 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.
• Health economic modelling and a qualitative process analysis study will also be embedded into the PALS trial.

Population

Any adult (aged 18 or over) who is identified as being isolated or at risk of loneliness. A socially isolated person is defined as as one for whom there is an “absence of social contacts or community involvement, or lack of access to services” in line with the definition used by Hampshire County Council.

Contacts

Sponsor: Univeristy of Southampton

Chief Investigator: Prof Anne Rogers

Trial Manager: Dr Kim Seymour

Email: [email protected]