ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623001286639

Ethics application status

Approved

Date submitted

2/11/2023

Date registered

11/12/2023

Date last updated

11/12/2023

Date data sharing statement initially provided

11/12/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Befriending with GENIE: Social intervention to address loneliness and social support for people with dementia and caregivers from Culturally and Linguistically Diverse (CaLD) communities.

Scientific title

Befriending with GENIE: An intervention to address loneliness, and social support and service access for Culturally and Linguistically Diverse (CaLD) people living with dementia and their caregivers.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

BwGEN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Depression

Anxiety

Loneliness

Lack of social support

Condition category

Condition code

Neurological

Dementias

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The BEFRIENDING with GENIE intervention comprises two interrelated components:

1. Social and emotional support to the participant living with dementia, and their family caregiver, through an evidenced-based and manualised Befriending intervention.

2. Support to reflect on capabilities, needs and preferences, improve knowledge about and access to resources and services, and engagement with existing and new network members for the participant-caregiver dyads through the GENIE intervention.

Befriending is non-directive emotional and social support. Befriending is defined as becoming a friend and having regular contact with someone, especially when they need help or support. Befriending generally consists of a series of conversations that are similar to those that someone would have with a social acquaintance. It involves the ongoing discussion of everyday topics and events such as hobbies or interests or things that someone enjoys in life. Befriending has often been implemented by organisations using volunteers and has been found to be successful in various areas of mental health. Befriending can provide some of the positive benefits a person can get from a therapist, such as time talking to a person, an ability to develop a relationship with someone, and being able to talk to someone who is caring, warm and understanding. It is not a substitute for professional psychological, social or medical assistance, which should always be sought if any concerns arise. However, it can be done by people without any psychological or medical training and volunteers, so is often considered a valuable addition to usual care. A trained bi-lingual facilitator/befriender will provide befriending to the participant living with dementia through an evidenced-based and manualised befriending intervention (Doyle et al 2018, Leung et al 2022, Fearn et al 2021).

GENIE (Generating Engagement in Network Involvement). The GENIE® intervention and online platform (https://www.genie.soton.ac.uk/eng/ ), developed by researchers at the University of Southampton, is an interactive, web-based self-management support intervention that maps participants’ social network; helps users reflect on available and acceptable support, elicits valued activities, capabilities, and interests (e.g., getting fitter, social activities, caregiving support); and links individuals to relevant local and online activities, resources, and services in a user-friendly facilitated process. A trained bi-lingual facilitator will navigate participants through GENIE during the intervention period supported by the intervention team and enabled by the GENIE® online tool. This facilitated system navigation approach will enable reflection, guidance and practical assistance with connecting to valued activities, resources, or services, and improving engagement with existing and new network members. These sessions will be delivered at an individual level and tailored to individual needs (Valaitis et al., 2021; Patel et al., 2022; Vassilev et al., 2019).

The GENIE tool comprises three key dimensions:

(i) A network mapping tool that facilitators use to explore participant support networks and their awareness of community resources, which is often low in CaLD populations. The network mapping tool is populated using an interview and a questionnaire. This activity generates a visual online (or paper-based) map of participants’ personal social networks and current activities. Discussing the network maps with a trained facilitator helps participants to build individual awareness of network structure and sources of support, reflect on their capabilities, preferences, and needs and enhance their knowledge and engagement with available activities, groups, resources, and services. When delivered at more than one time point the GENIE tool can measure changes in participants’ support networks (e.g. size, frequency of contact, network type, diversity) and service utilisation. This allows service providers using the tool to track client progress.

(ii) A database of existing prevention, support, hobby and wellbeing activities, resources and services designed to help identify and connect consumers with community organisations, health services and care providers in their local area (and online) that can be easily updated and shared between service providers, including CaLD service providers. The resources are wide – ranging, addressing a variety of needs, and offer suggestions that people may not have considered before. This supports ongoing use of the GENIE tool in the Partner Organisations to improve their service provision. The online platform is populated by a member of the research team, based on knowledge, including from the participants, from websites, and local knowledge. The online platform will list existing prevention, support, hobby and wellbeing activities and services that can be viewed by the participant.

(iii) An interactive social ‘engagement tool’. This tool will be based on a questionnaire and interview/discussion with the participants. This is a preference questionnaire and navigation tool that supports facilitators to identify the participants’ interests, preferences and valued activities. This generates suggestions of local resources (from the inbuilt database) that are most likely to help improve engagement and access to appropriate services. The discussion with the trained facilitators of the different options, preferences, and structure of network support is designed to improve participants’ engagement with new activities, with their existing network members, service awareness and access, as well as improve their motivation, self-efficacy, and the collective efficacy of their social support network.

Procedure

A trained BEFRIENDING with GENIE facilitator will provide 8 regular (e.g. weekly) visits interacting with the participants in a mutually agreed setting, or remotely via phone or video call, and will also work with the participants to complete the GENIE intervention. The intervention will be delivered in the language of the participants choice (Chinese, Vietnamese, South Asian languages, Italian, or English). It is anticipated that that each session will last for approximately an hour (but not more than two hours) so that the participants can have a meaningful conversation. Bilingual facilitators will undergo standardised training on the implementation of both Befriending and GENIE and will be given an operation manual to refer to throughout the intervention period. There will be ongoing support for all facilitators by the research team. The training will be delivered either face-to-face or via online modules and video conference. The facilitator will administer the intervention and will make notes of all intervention sessions in a standardised template, including the length of the sessions, topics discussed, social support and network connection and any other concerns that arise. BEFRIENDING with GENIE conversations will be audio recorded and later transcribed and thematically analysed to check fidelity of the implementation of the intervention.

A blinded researcher will collect outcome measures at specified time points.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The wait-list control group will receive usual care during the study period. They will be offered the intervention at the completion of their assessment period (12 weeks). However, the impact of the intervention will not be evaluated.

Control group

Active

Outcomes

Primary outcome [1]

Loneliness

Timepoint [1]

Baseline (T1, primary baseline) and weeks 4 (T2), 8 (T3, primary endpoint) and 16 (T4) post baseline follow up.

Secondary outcome [1]

Social support network

Timepoint [1]

Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)

Secondary outcome [2]

Quality of life

Timepoint [2]