Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000801718
Ethics application status
Approved
Date submitted
24/04/2022
Date registered
8/06/2022
Date last updated
30/08/2023
Date data sharing statement initially provided
8/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A controlled evaluation of social prescribing programs for adults in Queensland, Australia
Scientific title
A controlled evaluation of the effect of social prescribing programs on loneliness for adults in Queensland, Australia
Secondary ID [1] 306874 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Loneliness 325966 0
Mental health 325967 0
Condition category
Condition code
Public Health 323283 323283 0 0
Other public health
Mental Health 323284 323284 0 0
Anxiety
Mental Health 323285 323285 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study conducted at five sites in Queensland will examine the effects of social prescribing (SP) to a community based group program compared to primary care treatment as usual (TAU) on participants’ loneliness, mental wellbeing, and health service use. Social prescribing involves the person being referred (often by a GP or allied health professional) to a link worker (typically a nurse or social worker) who meets with the person to find a suitable social group program the person can join. The number of social groups will be at the discretion of the participant however we expect that it will only be one new group activity within the 8 week period between T1 and T2 surveys. Examples include arts based groups, exercise groups, and adult education classes, typically once a week for 1-2 hours (we will examine the first 8 weeks, although programs differ in duration). There is no maximum number of participants per group program, although they typically involve 8 - 20 participants, depending on the nature of the activity. Participants' attendance at meetings with the link worker and attendance at the group programs will be monitored by the link workers. The aim is to increase people's meaningful participation in social and community life which is likely to decrease loneliness, improve their mental health and wellbeing and decrease their reliance on primary health services.
Intervention code [1] 323328 0
Behaviour
Comparator / control treatment
The control sample will be frequent attending patients receiving treatment at GP Clinics in the same geographical locations as the social prescribing programs, i.e., Inala Primary Care and Complete Care Doctors in Mt Gravatt. They will receive medical and allied health appointments as usual in a primary care services but will not receive any social prescribing during the study.
Control group
Active

Outcomes
Primary outcome [1] 331016 0
Loneliness scores on the Roberts (1993) 8-item brief UCLA Loneliness Scale
Timepoint [1] 331016 0
There are three assessment timepoints: T1 when the person first engages with a social activity through the social prescribing program; T2 (8 weeks post-program commencement). T2 is considered the primary timepoint for assessing effects. In January to April 2023, we added a T3 only for the participants in the Social Prescribing condition. Due to rolling recruitment into the trial, the T3 was conducted an average of 18 months after T1,
Primary outcome [2] 331017 0
Mental Well-being measured on the 14-item Warwick Edinburgh Mental Wellbeing Scale (Hofmann, Carpenter & Curtiss, 2016).
Timepoint [2] 331017 0
T1 (pre-program), T2 (8 weeks later) (all participants) and T3 (18 months later) for the social prescribing participants only.
Primary outcome [3] 331018 0
Health Service Use past 3 months - sum total of participant reported number of visits to hospital, community mental health services, Counsellor, Psychologist, Psychiatrist, Social Worker, GP (in person, over the phone, or via home visit).
Timepoint [3] 331018 0
T1 (pre-program) and T2 (8 weeks post-program commencement) is the primary outcome timepoint.
Secondary outcome [1] 408494 0
Multiple group listing measure, defined as the number of groups listed (up to 6) and rated 5-7 out of 7 for importance (see Haslam et al., 2018; pp. 350-351).
Timepoint [1] 408494 0
T1 (pre-program) and T2 (8 weeks post-program commencement) for all participants, and T3 (18 months post-program commencement) for the social prescribing participants only.
Secondary outcome [2] 408495 0
New group identification measured with the 4-item social identity scale (Doosje, Ellemers & Spears, 1995)
Timepoint [2] 408495 0
T1 (pre-program) and T2 (8 weeks post-program commencement)
Secondary outcome [3] 408496 0
Multiple identity compatibility between old and new groups, average of 2 items (Haslam et al., 2018, pp. 349-350)
Timepoint [3] 408496 0
T1 (pre-program) and T2 (8 weeks post-program commencement)
Secondary outcome [4] 409389 0
Social support received and provided - average of 2 items from Haslam et al., 2005; see Haslam et al., 2018, p. 360
Timepoint [4] 409389 0
T1 (pre-program) and T2 (8 weeks post-program commencement)
Secondary outcome [5] 409390 0
Group based emotion regulation measured on 4 subscales of the Emotion Regulation of Others and Self (EROS) (Niven, Totterdell, Stride, & Holman, 2011)
Timepoint [5] 409390 0
T1 (pre-program) and T2 (8 weeks post-program commencement)
Secondary outcome [6] 410559 0
Single item rating of current health from 1 = very poor to 5 = very good
Timepoint [6] 410559 0
T1 (pre-program), T2 (8 weeks later) for all participants, and T3 (18 months later only for SP participants)
Secondary outcome [7] 410560 0
Single item that assesses loneliness frequency: “how often do you feel lonely?”' rated from 1 = never to 5 = often / always
Timepoint [7] 410560 0
T1 (pre-program), T2 (8 weeks later) for all participants, and T3 (18 months later) only for the SP participants

Eligibility
Key inclusion criteria
Inclusion criteria are individuals who are experiencing loneliness, aged 18 or over and have sufficient English language skills to be able to provide consent to participate in the research. We expect them to range in age, and to represent a variety of cultural and ethnic groups. We expect that some individuals will be experiencing mental health issues such as depression and social anxiety (which are highly correlated with loneliness) or older age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are that the study cannot include individuals people who are experiencing acute symptoms better addressed via an alternative service (e.g. suicidal ideation, manic or agitated behaviours, intoxication, significant cognitive impairment such as dementia). The Community Link Workers who screen individuals for the social prescribing program are trained Social Workers and they will direct such individuals to a more suitable service.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Repeated measures with 2 assessment timepoints
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The effectiveness of the social prescribing scheme (RQ1) will be evaluated using a series of 2 (conditions) x 2 (timepoints) mixed factorial ANOVAS to test changes over the two time points in primary outcome variables (loneliness, wellbeing, health service use) in the social prescribing condition v the TAU condition. RQ2 - how participants benefit from the social prescribing scheme (the extended SIMIC model) will be tested via a structural equation modelling approach that accounts for nested data (individuals within group programs). We will test relationships across time in number of important group memberships, new group identification, old and new group compatibility, self-efficacy in managing social identities, group based resources (support and emotion regulation) and the outcomes of loneliness, wellbeing, and health service use.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/02/2020
Date of last participant enrolment
Anticipated
29/07/2022
Actual
29/07/2022
Date of last data collection
Anticipated
30/09/2022
Actual
12/05/2023
Sample size
Target
90
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 37302 0
4077 - Inala
Recruitment postcode(s) [2] 37304 0
4122 - Upper Mount Gravatt
Recruitment postcode(s) [3] 37305 0
4217 - Gold Coast
Recruitment postcode(s) [4] 37406 0
4012 - Wavell Heights

Funding & Sponsors
Funding source category [1] 311189 0
Government body
Name [1] 311189 0
Australian Research Council
Country [1] 311189 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Research Grants Office
Cumbrae Stewart building 72
The University of QLD
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 312669 0
None
Name [1] 312669 0
Address [1] 312669 0
Country [1] 312669 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310722 0
The University of Queensland HREC
Ethics committee address [1] 310722 0
Ethics committee country [1] 310722 0
Australia
Date submitted for ethics approval [1] 310722 0
02/09/2019
Approval date [1] 310722 0
10/10/2019
Ethics approval number [1] 310722 0
2019/HE002287

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

Contacts
Principal investigator
Name 118638 0
Prof Genevieve Dingle
Address 118638 0
School of Psychology
The University of QLD
St Lucia QLD 4072
Country 118638 0
Australia
Phone 118638 0
+61733657295
Fax 118638 0
Email 118638 0
[email protected]
Contact person for public queries
Name 118639 0
Genevieve Dingle
Address 118639 0
School of Psychology
The University of QLD
St Lucia QLD 4072
Country 118639 0
Australia
Phone 118639 0
+61733657295
Fax 118639 0
Email 118639 0
[email protected]
Contact person for scientific queries
Name 118640 0
Genevieve Dingle
Address 118640 0
School of Psychology
The University of QLD
St Lucia QLD 4072
Country 118640 0
Australia
Phone 118640 0
+61733657295
Fax 118640 0
Email 118640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified cleaned data of published results will be available on approval from the Principal Investigator by email [email protected]
When will data be available (start and end dates)?
Data of published results will be available for 5 years after publication on approval of the Principal Investigator by email [email protected]
Available to whom?
Researchers who provide a methodologically sound proposal to the Principal Investigator and the research team.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Upon request and approval from the Principal Investigator email: [email protected]


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
SourceTitleYear of PublicationDOI
EmbaseA controlled evaluation of the effect of social prescribing programs on loneliness for adults in Queensland, Australia (protocol).2022https://dx.doi.org/10.1186/s12889-022-13743-3
N.B. These documents automatically identified may not have been verified by the study sponsor.