Trial Review

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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
20/12/2024
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] 310876 0
None
Universal Trial Number (UTN)
Trial acronym
BwGEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 331922 0
Depression 331923 0
Anxiety 331924 0
Loneliness 331925 0
Lack of social support 331926 0
Condition category
Condition code
Neurological 328653 328653 0 0
Dementias
Mental Health 328654 328654 0 0
Depression
Mental Health 328655 328655 0 0
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] 327298 0
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 (16 weeks). However, the impact of the intervention will not be evaluated.
Control group
Active

Outcomes
Primary outcome [1] 336449 0
Loneliness
Timepoint [1] 336449 0
Baseline (T1, primary baseline) and weeks 4 (T2), 8 (T3, primary endpoint) and 16 (T4) post baseline follow up.
Secondary outcome [1] 428445 0
Social support network
Timepoint [1] 428445 0
Baseline (T1), weeks 4 (T2), 8 (T3), and 16 (T4, post baseline)
Secondary outcome [2] 428446 0
Caregiver Quality of Life
Timepoint [2] 428446 0
Baseline (T1), weeks 4 (T2), 8 (T3), and 16 (T4, post baseline).
Secondary outcome [3] 428447 0
Social wellbeing
Timepoint [3] 428447 0
Baseline (T1), weeks 4 (T2), 8 (T3), and 16 (T4, post baseline).
Secondary outcome [4] 428448 0
Caregiver burden
Timepoint [4] 428448 0
Baseline (T1), weeks 4 (T2), 8 (T3), and 16 (T4, post baseline).
Secondary outcome [5] 428450 0
Health utilisation
Timepoint [5] 428450 0
Baseline (T1), and week 16 (T4, post baseline),
Secondary outcome [6] 428451 0
Process evaluation by caregivers and participants with dementia
Timepoint [6] 428451 0
Weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [7] 428452 0
Process evaluation by service provider staff and facilitators
Timepoint [7] 428452 0
Service provider staff and Facilitators: Weeks 4 (T2) and 16 (T4, post baseline).
Secondary outcome [8] 429481 0
Social support access
Timepoint [8] 429481 0
Baseline (T1) , weeks 4 (T2) and 8 (T3, post baseline).
Secondary outcome [9] 443409 0
Quality of life of people living with dementia
Timepoint [9] 443409 0
Secondary outcome [10] 443410 0
Quality of life of people living with dementia
Timepoint [10] 443410 0
Baseline (T1), weeks 4 (T2), 8 (T3), and 16 (T4, post baseline).
Secondary outcome [11] 443411 0
Social support access
Timepoint [11] 443411 0
Baseline (T1), weeks 4 (T2), 8 (T3), and 16 (T4, post baseline).
Secondary outcome [12] 443412 0
Social support access
Timepoint [12] 443412 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [13] 443413 0
Social support access
Timepoint [13] 443413 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [14] 443414 0
Social support access
Timepoint [14] 443414 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [15] 443415 0
Social support access
Timepoint [15] 443415 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [16] 443416 0
Social support access
Timepoint [16] 443416 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [17] 443417 0
Social support access
Timepoint [17] 443417 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [18] 443418 0
Social support access
Timepoint [18] 443418 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [19] 443419 0
Social support access
Timepoint [19] 443419 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [20] 443420 0
Social support access
Timepoint [20] 443420 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [21] 443421 0
Social support access
Timepoint [21] 443421 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)
Secondary outcome [22] 443422 0
Social support access
Timepoint [22] 443422 0
Baseline (T1) and weeks 4 (T2) and 16 (T4, post baseline)

Eligibility
Key inclusion criteria
People living with dementia: people with formally diagnosed or suspected dementia due to thinking and memory impairments; and/or as identified by carer/family member/the Partner Organisations; CaLD background (Chinese, South Asian, Italian, or Vietnamese); age 65 and over; living in the community; able to provide informed consent and communicate verbally.

Caregivers: family or non-family members who are providing informal care to the person with dementia, whether they live together or in a separate household.

Staff: people working at the Partner Organisations, or within service providers, will be eligible to participate in the process evaluation component.

Facilitators: bilingual research assistants who are trained to deliver the BEFRIENDING with GENIE intervention will be eligible to participate in the process evaluation component.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Dyads:
-Participants are with CaLD background other than Chinese, Italians, South Asian, or Vietnamese.
-Participants living with dementia age below 65 years.
-The person does not have formal diagnosis of dementia, or suspected dementia as indicated by the caregivers/family members.
-Participants are severely mentally or cognitively impaired and cannot provide informed consent.
-Participants do not provide informed consent for any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed

Allocation is concealed as the researchers, participants, and other parties involved in the trial are prevented from knowing the allocation of participants to the intervention or control groups until the moment of randomisation.

A trial statistician will be provided outside the field team. Participants will be randomly allocated to one of two groups after baseline assessment. A computer- generated random sequence available to the trial statistician but no other research staff will be used to produce random allocation. Randomisation allocation will be emailed to a researcher who will arrange for the intervention to commence. The trained facilitators will implement the intervention and will not be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use the RRApp web-based randomisation application. We will specify a stratified block randomisation, with four strata (the four centres), a total of 192 participants (48 x 4 centres). This is more than the target of 120, but allows for more participating dyads to be recruited in some centres without requiring additional randomization. The four strata will be assigned to the randomization scheme in alphabetical order (NSW, SA, Vic, WA).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical methods depend on the type and distribution of the outcome measures and might include, for example, descriptive analysis, mixed-effects Poisson regression models, sensitivity tests, and correlations. The primary and secondary outcomes will be analysed using the Generalised Estimating Equations (GEE) approach, a marginal model in which the effect of covariates on the outcome is averaged over individuals at each point in time and is compared over time. Data analysis will investigate possible mediating variables explaining any relationship found between BEFRIENDING with GENIE and loneliness. Possible intervening variables of interest include baseline loneliness; baseline social contacts; intensity of social contacts. Comparison will be made between participants who completed the study and those who dropped out to ensure that there is no difference between these two groups of participants. The adequacy of the randomisation procedures will be assessed by comparison of all baseline characteristics between the study groups for dichotomous variables and either ANOVA or Kruskal-Wallis test for continuous data.

A detailed health economic analysis will assess the cost effectiveness of the intervention comprising a cost-utility analysis based on the outcome of quality of life measures and health service utilisation data: hospital, primary care visits, mental health services, medications via a self-report questionnaire and partner organisations.

Sub-analysis of network change will also be extracted from Genie® to measures such as: 1) size of network (number of network members); 2) diversity of network (number of types of relationships, e.g. close family, distant family, acquaintances, friends, close family); 3) number of weak ties A (who are not family or friends; e.g. acquaintances, neighbours, colleagues); 4) number of weak ties B (subjective positioning: number of network members in outer circle of network diagram); 5) number of hobby or community groups; 6) frequency of contact (a sum, based on frequency of contact with all network members); 7) number of women in the network, 8) number of pets.

A phenomenological approach will underpin the qualitative analysis. NVivo will assist with analysis.

Fidelity assessment will investigate the extent to which the intervention is delivered as intended, including the degree to which it adheres to its core components, procedures, and protocols.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
164
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 315137 0
Government body
Name [1] 315137 0
NHMRC, Medical Research Future Fund (MRFF) MRF2024420
Country [1] 315137 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
SOCIAL AGEING (SAGE) FUTURES LAB, School of Arts and Humanities, 270 Joondalup Drive, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 317154 0
Other Collaborative groups
Name [1] 317154 0
National Ageing Research Institute Ltd
Address [1] 317154 0
34-54 Poplar Road, Gate 4, Building 8 (PO Box 2127) Royal Melbourne Hospital Parkville Victoria 3050
Country [1] 317154 0
Australia
Secondary sponsor category [2] 317156 0
University
Name [2] 317156 0
University of Sydney
Address [2] 317156 0
Camperdown NSW 2006, Australia
Country [2] 317156 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314075 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 314075 0
Ethics committee country [1] 314075 0
Australia
Date submitted for ethics approval [1] 314075 0
20/07/2023
Approval date [1] 314075 0
15/08/2023
Ethics approval number [1] 314075 0
ECU: 2023-04072-BALDASSAR

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130318 0
Prof Loretta Baldassar
Address 130318 0
SOCIAL AGEING (SAGE) FUTURES LAB, School of Arts and Humanities, Edith Cowan University, 270 Joondalup Drive, Joondalup WA 6027
Country 130318 0
Australia
Phone 130318 0
+61 8 6304 6386
Fax 130318 0
Email 130318 0
l.baldassar@ecu.edu.au
Contact person for public queries
Name 130319 0
Manonita Ghosh
Address 130319 0
SOCIAL AGEING (SAGE) FUTURES LAB, School of Arts and Humanities, Edith Cowan University, 270 Joondalup Drive, Joondalup WA 6027
Country 130319 0
Australia
Phone 130319 0
+61 8 6304 2341
Fax 130319 0
Email 130319 0
m.ghosh@ecu.edu.au
Contact person for scientific queries
Name 130320 0
Anita Goh
Address 130320 0
The National Ageing Research Institute 34-54 Poplar Road, Gate 4, Building 8, Royal Melbourne Hospital Parkville Victoria 3050
Country 130320 0
Australia
Phone 130320 0
+61 3 8387 2308
Fax 130320 0
Email 130320 0
a.goh@nari.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.