Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000968673
Ethics application status
Approved
Date submitted
21/07/2023
Date registered
6/09/2023
Date last updated
6/09/2023
Date data sharing statement initially provided
6/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a codesigned whole of community approach to promote social connection of older adults in ‘Connect Local’
Scientific title
Evaluation of a codesigned whole of community approach addressing social connection of older adults in ‘Connect Local’ to target loneliness, social isolation and depressive symptoms and improve wellbeing.
Secondary ID [1] 308702 0
Nil known
Universal Trial Number (UTN)
U1111-1286-7870
Trial acronym
CCtC evaluation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any chronic health condition 328635 0
depressive symptoms 329154 0
Loneliness 329155 0
Social Isolation 329156 0
Physical wellbeing 330637 0
mental wellbeing 330638 0
Condition category
Condition code
Public Health 325641 325641 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Connect Local -– a codesigned social prescribing program
This is a non-randomised trial where all eligible individuals living in the Local Government Area (LGA) of Glen Eira City Council who are participating in Connect Local will be invited to participate in the evaluation.
The Connect Local service will be delivered to the individual by the community connector in the following manner, with the involvement in the Connect Local program being over three months – although this will vary, based on the individual needs and preferences - while the evaluation will be following participants over 12 months:
1. Spend at least an hour in a face to face appointment with participants to:
a. Identify what matters to them;
b. Work together on generating goals to address a social need, and a develop a plan to achieve these goals through linking them to activities and/or programs being offered in the Local Government Area (LGA) of Glen Eira City Council;
c. Some examples of activities include: walking group, gardening group, crochet club, book club. These can be offered at the local community house or the local library.
2. Have a second face to face session of approximately an hour the following week, where:
a. The individual will be supported to access these activities/programs through accessing local resources;
3. Have a follow up appointment by phone of approximately 20 minutes within a week of accessing the activity/program to assess whether the activities/programs have met their needs and they will continue to engage;
a. Should there be any issues, the Community Connector may either engage with the program/activity provider to address them, or work with the individual to develop a new goal, plan and access new activity/program.
4. Have follow up phone calls of approximately 20 minutes after 2-3 weeks to ascertain progress;
a. Should the individual have issues or need more engagement in additional activities/programs, face to face appointments to ascertain their needs and linking to additional activities/programs will occur.
5. Continue with follow up calls of approximately 20 minutes duration every 2-4 weeks, until 3 months where the final call outlines the Community Connector has fulfilled their role and the individual can continue engaging in the activity/program.
Community Connectors:
These are individuals with a tertiary qualification in health or social care related field. They are selected specifically for their high emotional intelligence, including the ability to build rapport with individuals, listen non-judgementally and work with individuals to identify what matters to them. A community development background is highly desirable. Prior to engaging participants, all Community Connectors are provided with a comprehensive orientation guide about the program and the activities involved and undergo training over 2 weeks prior to seeing community members, in social prescribing (WHO developed online training program of 2hr duration, wellness and reablement (including identifying ‘what matters to you’ and goal setting) of 4 hours duration, Cultural Diversity webinars and training modules of 2 hours duration, mental health first aid of 1 hour duration and trauma informed care of 2 hours duration.
There are weekly meetings with the manager and community connectors to discuss the activities the community connectors have undertaken, debrief and plan the next week.
Strategies to monitor adherence of the intervention:
The program has developed documentation tools to capture information regarding engagement of participants through the program, including when participants are contacted, duration, activities and outcomes as part of the care delivery of the program.
The codesign process to develop Connect Local:
Codesign involved occurred between October 2021- December 2022 online and in local venues, engaged six community members (six 2hr sessions), nine local social service stakeholders (three 2hr sessions) and eight local healthcare service stakeholders (six 1.5hr sessions) living and/or working locally. Awareness of the program, recruitment of program participants, delivering the program and how the program would measure success were articulated and tested.


Intervention code [1] 325166 0
Treatment: Other
Intervention code [2] 326678 0
Lifestyle
Comparator / control treatment
The comparator group will not have any prescribed intervention additional to usual care, but live outside the target Local Government Area.

In general, usual care consists of an ad hoc approach by some healthcare providers regarding asking individuals about their social connection needs and raising potential non-medical interventions as an avenue to address them, and leaving it to the individuals to pursue. Information about social connection activities is available online and at various community centres, however individuals need to seek the information out to find out about them.
Control group
Active

Outcomes
Primary outcome [1] 333487 0
Mean change in loneliness from baseline as measured by the University of California Los Angeles 3 - item Loneliness scale (UCLA-3)
Timepoint [1] 333487 0
Older community member participants: measured at Baseline, 3, 6 and 12 months (primary end point) post baseline
Secondary outcome [1] 417243 0
Mean change in social isolation from baseline as measured by Lubben-18
Timepoint [1] 417243 0
Older community member participants: Baseline, 3, 6 and 12 months post baseline
Secondary outcome [2] 417244 0
Mean change in social anxiety from baseline as measured by Mini-Social Phobia Inventory (Mini-SPIN)
Timepoint [2] 417244 0
Older community member participant: Baseline, 3, 6 and 12 months post baseline
Secondary outcome [3] 417245 0
Mean change in depressive symptoms from baseline measured by Geriatric Depression Scale - 5 item (GDS-5)
Timepoint [3] 417245 0
Older community member participants: Baseline, 3, 6 and 12 months post baseline
Secondary outcome [4] 417246 0
Mean change in physical wellbeing from baseline as measured by Euroqol 5 dimension scale (EQ-5D)
Timepoint [4] 417246 0
Older community member participants: Baseline, 3, 6 and 12 months post baseline
Volunteer participants: Baseline and 3 months post baseline.
Secondary outcome [5] 417247 0
Mean change in quality of life from baseline as measured by EQ-5D
Timepoint [5] 417247 0
Older community member participants: Baseline, 3, 6 and 12 months post baseline
Volunteer participants: Baseline and 3 months post baseline
Secondary outcome [6] 417248 0
Mean change in mental wellbeing from baseline as measured by Warwick-Edinburgh mental wellbeing scale
Timepoint [6] 417248 0
Older community member participants: Baseline, 3, 6 and 12 months post baseline
Volunteer participants: Baseline and 3 months post baseline.
Secondary outcome [7] 417249 0
Proportion of older community member participants who achieved their goals as measured by the Goal Attainment Scale
Timepoint [7] 417249 0
Older community member participants: At the conclusion of the study.
Secondary outcome [8] 417250 0
Health and community resource use by older community participants will be assessed as a composite outcome using the Resource Use Survey.
Timepoint [8] 417250 0
Older community member participants: Baseline, 3, 6 and 12 months post baseline.
Secondary outcome [9] 419020 0
Perceptions (acceptability) of program by staff (healthcare and in General Practice) and other referral agencies through semi-structured interviews. A member of the research team will conduct the interviews that will be of up to 1 hour duration. The interviews will be audio-recorded.
Timepoint [9] 419020 0
Healthcare participants: At 3 months from when their patients were engaged in the program
Secondary outcome [10] 419021 0
Social Care providers: Impact on social care services as measured by the Community Service Impact Survey (adapted from NHS guidance, 2020). This tool should take approximately 15 minutes to complete.
Timepoint [10] 419021 0
At 6 monthly intervals, starting from when the program began engaging and utilising their services for a maximum of 2 years.
Secondary outcome [11] 419022 0
Social Care Providers: Perceptions (acceptability), use and satisfaction with program through semi-structured interviews. A member of the research team will conduct the interviews that will be of up to 1 hour duration. The interviews will be audio-recorded.
Timepoint [11] 419022 0
Every six months starting from when the program began engaging and utilising the Connect Local program, the for a maximum of 24 months
Secondary outcome [12] 419023 0
Program cost effectiveness assessed through calculating the Social Return on Investment. Resource use and costs will be collected from the participant using the Resource Use Survey.
Timepoint [12] 419023 0
At end of trial
Secondary outcome [13] 419024 0
Reach of the intervention will be determined using demographic data from participants. eg. age, gender and the number of clients who engaged with the program, and this data will be obtained from audit of study recruitment and service delivery records.
Timepoint [13] 419024 0
At 12 and 24 months after the start of the trial.
Secondary outcome [14] 419025 0
Adoption ie. uptake of the intervention: will be determined by administrative data regarding number of participants who complete the program, obtained from audit of study and service delivery records.
Timepoint [14] 419025 0
at 12 and 24 months after the start of the trial.
Secondary outcome [15] 419026 0
Feasibility ie. (actual fit) of the intervention and the extent it can be used in the participating organisations. This will be determined using a. routinely collected program data (e.g. uptake by community members, staff and organisations and number of participants and time taken to complete the program) obtained from audit of study and service delivery records, and b. interviews with participants, volunteers and staff re: organisational and support systems to enable the program to run. A member of the research team will conduct the interviews that will be of up to 1 hour duration. The interviews will be audio-recorded.
Timepoint [15] 419026 0
At 12 and 24 months after the start of the trial
Secondary outcome [16] 425772 0
Appropriateness, perceived fit, of the intervention will be determined through interviews with participants, volunteers and staff. A member of the research team will conduct the interviews that will be of up to 1 hour duration. The interviews will be audio-recorded.
Timepoint [16] 425772 0
3 months after baseline
Secondary outcome [17] 425773 0
Fidelity, uptake of the intervention into practice as planned, will be determined through process data, reviewing participants undergoing all key components of the program , obtained from audit of study and service delivery records. Also interviews with participants, volunteers and staff to ascertain whether their activities aligned to the planned program key components. A member of the research team will conduct the interviews that will be of up to 1 hour duration. The interviews will be audio-recorded.
Timepoint [17] 425773 0
at 12 and 24 months from the start of the trial
Secondary outcome [18] 425774 0
Sustainability, extent to which the intervention has been embedded into the organization, will be determined through process measures to ascertain the level of embeddedness of the program within the organisational systems and interviews with participants, volunteers and staff regarding their perceptions of the program being part of their business as usual activities. A member of the research team will conduct the interviews that will be of up to 1 hour duration. The interviews will be audio-recorded.
Timepoint [18] 425774 0
At 12 and 24 months from the start of the trial

Eligibility
Key inclusion criteria
Intervention group: Aged 65 years or older; Understand and speak English sufficiently to understand and be involved in the program; Live in the Glen Eira Local Government Area (Victoria); Community dwelling (including those experiencing homelessness); Have at least one chronic health condition; Are at risk or experiencing loneliness, social isolation and/or depressive symptoms.
Comparator Group: all of the above, except live outside of the Glen Eira Local Government Area.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Live in residential aged care; individuals who do not speak English sufficiently to understand the program; and individuals who do not have the cognitive capacity to consent

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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
The primary outcome is a reduction in loneliness at 3 months for participants receiving the Connect Local program, when compared to the comparator group. A program conducting similar activities found a statistically significant reduction in mean UCLA-3 scores of 0.85, with a medium effect size of 0.37 (Brown, 2018). Using this effect size and aiming for 0.9 power at 0.05 alpha we need 76 participants in each group: the intervention and matched comparator.

Allowing for 15% loss to follow-up at 3 months we have inflated the sample size to 88 per arm, for a total of 176 participants in both the intervention and comparator groups.
Reference:
Brown, C., Hammond, J., Jones, M., Kimberlee, R., BAB Community Researchers. (2018). Community Webs Final Evaluation Report. Retrieved from Bristol, UK: https://bristolageingbetter.org.uk/userfiles/files/CR06%20-%20Community%20Webs%20Final%20Evaluation%20Report.pdf

Statistical analysis
Outcome 1: Intervention evaluation - program effectiveness.
Quantitative data analysis
For all quantitative, repeated, continuous individual level variables (loneliness, social isolation, social anxiety, depressive symptoms, wellbeing, quality of life) the main research question will be whether the study intervention is effective at improving the outcome of interest compared with usual care . Modelling these data will focus on fitting linear mixed models using different covariance matrices such as: unstructured, an exchangeable-changeable and AR level-1 residual matrices, where the mean structure of all fitted models include a term for intervention group and a term for time and an interaction term for time and intervention. Non-linear outcomes will be fitted using Generalised Estimating Equations (GEE) analysis which requires that the missingness mechanism is Missing Completely At Random (MCAR). Alternatively, polynomials and/or piecewise linear functions will be utilised for modelling outcomes with non-linear growth trajectories if responses are Missing At Random (MAR).
For quantitative, binary or dichotomous individual level outcomes (scales that have cut-off scores: loneliness (UCLA-3), social anxiety, depressive symptoms) additional analysis will be undertaken addressing the research question: do the interventions differ in their effectiveness , such that individuals in the intervention group experience a greater improvement in their probability of achieving the desired outcome comparted to those receiving usu al care . Generalized linear mixed models for dichotomous outcomes will be used as well as GEE. The typology of missing data will be investigated to make sure that the assumptions of the adopted statistical technique are not violated.
To identify the model that fits the data best, the Akaike information criterion (AIC) and Bayesian information criterion (BIC) will be used to compare non-nested models and the log-likelihood ratio test will be used to compare nested models. A model with a smaller AIC or BIC will be considered to fit the data best.
All quantitative community and system level variables, as well as the goal attainment will be analysed descriptively. Descriptive statistics will be presented as proportions, means (standard deviations) or, for variables that did not conform to a normal or log-normal distribution, medians (interquartile range).

Statistical analysis will be performed using STATA V.15.0 (STATA Corp LP., College Station, Texas, USA). We will use a Type I error rate of 5% to indicate statistical significance, with 95% confidence intervals (CI).

Missing Data: General and generalised linear mixed models use maximum likelihood estimation which produces robust/unbiased estimates as they make implicit corrections for missing data, hence they are likely to retain more power if participants are lost to follow-up than traditional repeated-measures ANOVA/ANCOVA approaches which use “complete-case-analysis” approach that only includes cases with no missing data in the analysis.
If more than 5% of the outcome data are missing, a sensitivity analysis will be conducted comparing fitted models in terms of estimates and corresponding standard errors using maximum likelihood estimation with and without considering different imputation techniques.

Qualitative Data Analysis
For all qualitative individual, community and system level variables, interviews with participants will be audio-recorded, transcribed and then analysed utilising thematic analysis. Thematic analysis involves finding repeated patterns of meaning within qualitative data (Braun & Clarke, 2006) and will be facilitated with the use of qualitative management and analysis software such as NVivo (Q.S.R. International, 2016). In addition, an interview summary will be created for each interview and circulated to the research team, facilitating the team’s ongoing knowledge of the data being collected. An inductive approach will be used within the project, which allows for themes and findings to emerge from the data, grounding the findings in the perspectives and experiences of participants.

Mixed method approach: Triangulation will be used to combine the qualitative and quantitative data using a deductive-simultaneous design (Schoonenboom & Johnson, 2017) where the core component is quantitative, and the supplemental component is qualitative.

Outcome 2: Health Economic Evaluation - program cost effectiveness
The research team will identify and categorise the stakeholders, and the outcomes most relevant for each, and then apply the following tools of SROI: consideration of deadweight, displacement, attribution and drop off. We will do this through discussion between team members undertaking evaluation and program implementation in relation to each of the outcomes considered in the SROI.
Calculating the SROI:
The calculation of the SROI will consider the total value of the inputs in the program. The discounted, monetised value of benefits and outcomes will be divided by total investment (inputs) to estimate the SROI ratio.

Outcome 3: Implementation - Process evaluation
1. Reach and adoption: This will include quantitative data that will be reported descriptively, using frequencies and proportions .
2. Feasibility., Acceptability and Appropriateness: This will include quantitative data that will be reported descriptively, using frequencies and proportions. Qualitative data will be analysed thematically using an inductive approach, as described above , to ascertain themes around feasibility, acceptably and appropriateness of the program. Process data regarding organisational support systems and processes will also be reviewed by the research team, discussed as a group, considering the content in light of the qualitative data analysis results to form synthesised outcomes. This information will be reported narratively.
3. Fidelity and sustainability Interview qualitative data will be analysed deductively, to ascertain whether program components were delivered as planned. Further, information on organisational support systems and process will be reviewed by the research team to consider the sustainability of the program. This information will be reported narratively.
Mixed methods approach: Expansion method, using simultaneous design where the core component is quantitative and the supplemental component is qualitative (Schoonenboom & Johnson, 2017).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2023
Actual
Date of last participant enrolment
Anticipated
17/03/2025
Actual
Date of last data collection
Anticipated
15/09/2025
Actual
Sample size
Target
176
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23774 0
The Alfred - Melbourne
Recruitment hospital [2] 23775 0
Sandringham Hospital - Sandringham
Recruitment hospital [3] 23776 0
Caulfield Hospital - Caulfield
Recruitment postcode(s) [1] 39221 0
3004 - Melbourne
Recruitment postcode(s) [2] 39223 0
3162 - Caulfield
Recruitment postcode(s) [3] 39222 0
3191 - Sandringham

Funding & Sponsors
Funding source category [1] 312927 0
Charities/Societies/Foundations
Name [1] 312927 0
The Ian Potter Foundation
Country [1] 312927 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bolton Clarke
Address
Level 1, 347 Burwood Highway, Forest Hill, Victoria 3131
Country
Australia
Secondary sponsor category [1] 314610 0
None
Name [1] 314610 0
Address [1] 314610 0
Country [1] 314610 0
Other collaborator category [1] 282519 0
Hospital
Name [1] 282519 0
Alfred Health
Address [1] 282519 0
55 Commercial Road, Melbourne Victoria 3004 ·
Country [1] 282519 0
Australia
Other collaborator category [2] 282520 0
Other
Name [2] 282520 0
Australian Disease Management Association
Address [2] 282520 0
55 Commercial Road, Melbourne Victoria 3004 ·
Country [2] 282520 0
Australia
Other collaborator category [3] 282521 0
Other
Name [3] 282521 0
South Eastern Melbourne Primary Health Network
Address [3] 282521 0
11 Corporate Drive, Heatherton Victoria 3202
Country [3] 282521 0
Australia
Other collaborator category [4] 282749 0
University
Name [4] 282749 0
Monash University
Address [4] 282749 0
School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Rd, St Kilda, VIC 3004
Country [4] 282749 0
Australia
Other collaborator category [5] 282750 0
Charities/Societies/Foundations
Name [5] 282750 0
Ending Loneliness Together
Address [5] 282750 0
C/Way Ahead NSW. Level 2, Building C/33 Saunders St, Pyrmont, NSW 2009
Country [5] 282750 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312199 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312199 0
55 Commercial Road, Melbourne Victoria 3004 ·
Ethics committee country [1] 312199 0
Australia
Date submitted for ethics approval [1] 312199 0
23/01/2023
Approval date [1] 312199 0
23/03/2023
Ethics approval number [1] 312199 0
91660
Ethics committee name [2] 312200 0
Bolton Clarke Human Research Ethics Committee
Ethics committee address [2] 312200 0
Level 1, 347 Burwood Highway, Forest Hill, Victoria 3131
Ethics committee country [2] 312200 0
Australia
Date submitted for ethics approval [2] 312200 0
10/11/2022
Approval date [2] 312200 0
22/12/2022
Ethics approval number [2] 312200 0
220005

Summary
Brief summary
Connect Local is a new codesigned social prescribing program that aims to support older community members with at least one chronic health condition who may be experiencing or are at risk of loneliness, social isolation and /or depressive symptoms to links them into local social community activities/programs. The aim of the program is to reduce loneliness, social isolation and/or depressive symptoms and improve physical, mental and social wellbeing.
Connect Local has been developed through codesign (2021-2022) including local community stakeholders with the aim to develop a program that is fit for purpose, feasible and sustainable.
This evaluation includes program effectiveness, health economic and implementation evaluation. Using a Type 1 Hybrid effectiveness-implementation design permits testing of the outcomes of the intervention while gathering information on its implementation. This information will support the rollout and inform sustainability of Connect Local more broadly.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123826 0
Dr Rajna Ogrin
Address 123826 0
Bolton Clarke Research Institute, Level 1, 347 Burwood Highway, Forest Hill, Victoria, 3131
Country 123826 0
Australia
Phone 123826 0
+61400253459
Fax 123826 0
Email 123826 0
rogrin@boltonclarke.com.au
Contact person for public queries
Name 123827 0
Dr Rajna Ogrin
Address 123827 0
Bolton Clarke Research Institute, Level 1, 347 Burwood Highway, Forest Hill, Victoria, 3131
Country 123827 0
Australia
Phone 123827 0
+61400253459
Fax 123827 0
Email 123827 0
rogrin@boltonclarke.com.au
Contact person for scientific queries
Name 123828 0
Dr Rajna Ogrin
Address 123828 0
Bolton Clarke Research Institute, Level 1, 347 Burwood Highway, Forest Hill, Victoria, 3131
Country 123828 0
Australia
Phone 123828 0
+61400253459
Fax 123828 0
Email 123828 0
rogrin@boltonclarke.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Current HREC approval does not include enabling data sharing at this level. Aggregate data will be shared, but all of the individual quantitative data collected during the trial will be accessible upon request and HREC approval will be sought separately.
When will data be available (start and end dates)?
At the completion of the trial and after HREC approval has been given to enable us to do this. We anticipate this will be from August 2025 and data availability will be possible until 7 years after the completion of the study (August 2032)
Available to whom?
Researchers who request the data to use in relevant research that has obtained ethics approval.
Available for what types of analyses?
For secondary analysis of data for research purposes, such as meta-analysis in systematic reviews.
How or where can data be obtained?
Researchers to contact the principal investigator: Dr Rajna Ogrin at rogrin@boltonclarke.com.au


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