Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001233718
Ethics application status
Approved
Date submitted
8/09/2022
Date registered
13/09/2022
Date last updated
10/04/2024
Date data sharing statement initially provided
13/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing an online community on level of depression among older Australians
Scientific title
A randomised controlled trial of an online peer support intervention on symptoms of depression among community-dwelling older adults living in rural Australia
Secondary ID [1] 307942 0
GNT1150496
Universal Trial Number (UTN)
U1111-1282-3161
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 327594 0
Anxiety 327595 0
Loneliness 327596 0
Quality of Life 327597 0
Condition category
Condition code
Mental Health 324682 324682 0 0
Depression
Mental Health 324683 324683 0 0
Anxiety
Public Health 324684 324684 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Web-based peer support intervention: Individuals in the intervention arm will receive usual care plus access to a secure, study-specific, unmoderated online community (the "Seniors Connect" website) dedicated to older people, where they can meet and engage in asynchronous one-to-one and group-based communication with other individuals in the intervention arm. The Seniors Connect website adheres to user-centred design processes and web design guidelines for older people, and will be accessible via computers and mobile devices for the duration of the trial. All individuals in the intervention arm will be sent an email invitation to access the private online community from a member of the research team, including the website address, login details, and basic instructions for use, as well as the BeyondBlue 'Connections Matter' booklet which emphasises the importance of social connections for improving mental health and wellbeing. The booklet takes around 20 minutes to read, however perusal is at the participant's own discretion. Individuals can: 1) create a profile using an online template. Individuals will have the option to include an avatar. As part of the profile creation process, each individual will be required to accept the terms and conditions of using the website including respectful communication, maintaining privacy, and promoting a positive culture among the online community. The research team will check all profiles prior to upload; 2) send and receive one-to-one private messages: a website function will enable individuals to use keywords and filters to search the profiles of other members of the intervention arm and identify those that meet specific criteria such as a particular interest or hobby. Individuals will be able to send connection requests directly to individuals with whom they wish to communicate one-to-one. Once individuals are connected, they will be able to communicate with each other one-to-one via asynchronous private messages linked to their profile, in order to share concerns and provide support to each other; and 3) view and post group-based messages: individuals will be able to communicate with all members of the group by reading and commenting on posts, starting a new discussion topic by posting questions, and sharing content. The research team will post at least 1 news item each month, e.g. links to tip sheets about creating connections, a link to information about the United Nations International Day of Friendship, a link to information about the FriendLine service. Individuals will receive sms and/or email prompts alerting them to new content (e.g. new members joined, new news items) and to remind them to log on if they have not accessed the website for 2 weeks. An online complaints form allows participants to report inappropriate communication or posts of concern to the research team; these will be reviewed and addressed by the research team upon receipt. The online community will be launched when the group has achieved a critical mass of 20 registered profiles, and will be accessible to individuals in the intervention group as often as they choose to engage, for a six month intervention period. Adherence to the intervention will be monitored by inbuilt software tracking profile created, website logins, post counts, connections requested counts, message counts and minutes per login session. The website will be made available to individuals in the control arm at the end of the 6-month intervention period.
Intervention code [1] 324399 0
Behaviour
Comparator / control treatment
Usual care: Individuals allocated to the control arm will continue to receive usual care including any public or privately funded consumer-directed aged care services they may be receiving. Individuals in the control arm will also receive a copy of the BeyondBlue 'Connections Matter' booklet which emphasises the importance of social connections for improving mental health and wellbeing. In addition, as part of duty of care, any individuals who indicate severe depression (score >=12 on GDS-15) at baseline or follow-up will be contacted by a member of the research team with a recommendation to consult their local doctor or aged care provider (if applicable).
Control group
Active

Outcomes
Primary outcome [1] 332503 0
Mean depression score assessed by the 15-item Geriatric Depression Scale (GDS-15)
Timepoint [1] 332503 0
Baseline, and at 3 months and 6 months (primary timepoint) after completion of baseline measures
Secondary outcome [1] 413758 0
Anxiety assessed by the 20-item Geriatric Anxiety Inventory
Timepoint [1] 413758 0
Baseline, and at 3 and 6 months after completion of baseline measures
Secondary outcome [2] 413759 0
Loneliness assessed by the 11-item De Jong-Gierveld Loneliness Scale
Timepoint [2] 413759 0
Baseline, and at 3 months and 6 months after completion of baseline measures
Secondary outcome [3] 413760 0
Quality of life will be assessed using the 6-item Quality of Life- Aged Care Consumer tool (QOL-ACC), rather than the SF-36.
Timepoint [3] 413760 0
Baseline, and at 3 months and 6 months after completion of baseline measures
Secondary outcome [4] 433862 0
ONS Life Satisfaction Scale
Timepoint [4] 433862 0
Secondary outcome [5] 433863 0
ONS Life Satisfaction Scale
Timepoint [5] 433863 0
Baseline, 3 and 6 months post-baseline

Eligibility
Key inclusion criteria
(i) Aged 65 years or older; (ii) English speaking; (iii) have a life expectancy of more than 6 months; (iv) live independently at home with low levels of support i.e. Commonwealth Home Support Programme or Home Care Package Level 1 or 2; (v) have access to the internet.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) under a guardianship order

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. Allocation involves randomisation by computer by an independent statistician at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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: Studies with older community-based samples have shown the GDS-15 score to have a mean ranging from 2.6 (SD=2.3) to 5.1 (SD=3.5). Considering this previous data, a sample of 100 people per group at 6 month follow-up will enable the detection of at least a 2 point mean difference between intervention and control groups with over 90% power and 5% significance. A 2-point difference on the GDS-15 represents a minimally clinically important difference. Allowing for 20% attrition by 6 month follow-up, approximately 120 participants will need to recruited per group at baseline.

Statistical methods/analysis: Data will be analysed using the intent-to-treat principal. Primary outcome group differences will be tested using a mixed effects linear regression model, which will include fixed effects for baseline GDS-15 score, treatment group, time and interaction between treatment group and time. Sub-group analysis using residential location (capital city vs regional/rural/remote areas), and level of social participation (measured via the 15-item Australian Community Participation Questionnaire; ACPQ; Berry 2007; high versus low social participation) will be undertaken. Within-person serial correlations will be modelled with an unstructured residual correlation matrix. The interaction term in the model will be used to determine treatment group differences in least-square means at each follow-up, with the primary comparison being at 6 months. The mixed model provides unbiased estimates of the treatment effect under the assumption that data are missing at random. Sensitivity analyses using non-ignorable pattern-mixture and selection models will be used to investigate the robustness of conclusions across these models for missing data. The same approach will be used to examine continuous secondary outcomes. Where secondary outcome data are categorical, the significance of the difference in proportions will be assessed using a generalised linear mixed model with a logit link function and a binomial distribution.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312210 0
Government body
Name [1] 312210 0
National Health and Medical Research Council
Country [1] 312210 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan
NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 313738 0
None
Name [1] 313738 0
Address [1] 313738 0
Country [1] 313738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311591 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 311591 0
Ethics committee country [1] 311591 0
Australia
Date submitted for ethics approval [1] 311591 0
15/11/2018
Approval date [1] 311591 0
07/03/2019
Ethics approval number [1] 311591 0
H-2018-0461

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

Contacts
Principal investigator
Name 121638 0
Dr Allison Boyes
Address 121638 0
Health Behaviour Research Collaborative
University of Newcastle
HMRI Building, L4W
University Drive
Callaghan, NSW 2308 Australia
Country 121638 0
Australia
Phone 121638 0
+61 2 40420703
Fax 121638 0
Email 121638 0
[email protected]
Contact person for public queries
Name 121639 0
Natasha Noble
Address 121639 0
Health Behaviour Research Collaborative
University of Newcastle
HMRI Building, L4W
University Drive
Callaghan, NSW 2308 Australia
Country 121639 0
Australia
Phone 121639 0
+61 2 4042 0652
Fax 121639 0
Email 121639 0
[email protected]
Contact person for scientific queries
Name 121640 0
Allison Boyes
Address 121640 0
Health Behaviour Research Collaborative
University of Newcastle
HMRI Building, L4W
University Drive
Callaghan, NSW 2308 Australia
Country 121640 0
Australia
Phone 121640 0
+61 2 4042 0703
Fax 121640 0
Email 121640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing of IPD is not approved by the Ethics Committee


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17097Study protocol  [email protected]
17098Ethical approval  [email protected]



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.