Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000163404
Ethics application status
Approved
Date submitted
4/02/2016
Date registered
10/02/2016
Date last updated
6/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a bespoke e-health platform on general health and wellbeing in young Australians: a pilot study
Scientific title
A pilot 'proof of concept' study to evaluate the effect of an innovative web-based resource, NSW Synergy Online Ecosystem, on general health and wellbeing in young Australians aged 16 to 25 years in three locations (Western Sydney, Central Coast and Far West).
Secondary ID [1] 288481 0
None
Universal Trial Number (UTN)
U1111-1179-2150
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 297529 0
General health and wellbeing 297583 0
Condition category
Condition code
Mental Health 297728 297728 0 0
Depression
Mental Health 297729 297729 0 0
Anxiety
Public Health 297778 297778 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The NSW Synergy Online Ecosystem is currently comprised of three existing online resources:

1. HAPPINESS CENTRAL – developed by the Brain and Mind Centre (The University of Sydney) in collaboration with the Young and Well CRC, young people identify their current needs (eg. managing stress) and through the use of smart algorithms and interoperable apps and etools, develop a personalised ‘wellbeing plan’;

2. ReachOut.com Next Step – developed by ReachOut.com Australia, The University of Melbourne and 13 youth service partners in collaboration with the Young and Well CRC, ReachOut.com Next Step is a web-based tool that uses creative algorithms designed to help young people work out what’s going on, find free and paid support services, as well as suggest practical tips for immediate use;

3. Mental Health eClinic – developed by the Brain and Mind Centre (The University of Sydney) in collaboration with the Young and Well CRC, the Mental Health eClinic is a real-time primary care clinic that offers young people immediate online assessment, as well as timely support and programs, via a ‘video-visit’ with a health professional and share plan.

Note, each of these apps and etools currently has their own Human Research Ethics Committee (HREC) approvals: HAPPINESS CENTRAL (The University of Sydney, Protocol Number 2014/862); ReachOut.com Next Step (The University of Melbourne, Protocol Number 1341063.6); and, the Mental Health eClinic (The University of Sydney, Protocol Number 2014/689).

The NSW Synergy Online Ecosystem will be piloted in NSW but restricted to three target communities including the Central Coast, Western Sydney and Far West. The boundaries of these regions have been determined by the geographical boundaries used by the Local Health District (LHD) of each region: the Central Coast LHD, Western Sydney LHD and Far West LHD, including their associated broader catchment areas. Note: the trial will not be conducted within the physical health services of any of these LHDs.

Participants aged 16 to 25 years are free to use (or not use) any of the three resources at their discretion throughout the 90-day intervention period. Adherence to the intervention will be assessed via online surveys at five time points (Day 1, Day 15, Day 30, Day 60 and Day 90).
Intervention code [1] 293832 0
Treatment: Other
Intervention code [2] 293873 0
Lifestyle
Intervention code [3] 293874 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297260 0
Primary outcome 1: Percentage (%) change in item measuring general health and wellbeing: “How would you rate your overall health?” (five-point Likert scale response ‘very bad’ to ‘very good’).
Timepoint [1] 297260 0
Primary outcome 1:
Baseline (or Day 1), Day 15, Day 30, Day 60 and Day 90
Primary outcome [2] 297305 0
Primary outcome 2: Percentage (%) change in item measuring overall mental health: “How would you rate your overall mental health?” (five-point Likert scale response ‘very bad’ to ‘very good’).
Timepoint [2] 297305 0
Primary outcome 2:
Baseline (or Day 1), Day 15, Day 30, Day 60 and Day 90
Primary outcome [3] 297306 0
Primary outcome 3: Mean score on item measuring overall rating of the system: “What is your overall (star) rating of the NSW Synergy Online Ecosystem?” (‘1’ to ‘5’ star rating).
Timepoint [3] 297306 0
Primary outcome 3:
Day 90 only
Secondary outcome [1] 320503 0
Secondary outcome 1: Percentage (%) change over time as measured on analytics including on measures of mental health: 10-item Kessler Psychological Distress Scale (K-1); five-item suicide frequency questionnaire; 14-item Mental Health Continuum – Short Form; abbreviated Oxford Happiness Questionnaire.
Timepoint [1] 320503 0
Secondary outcome 1:
Baseline (or Day 1), Day 15, Day 30, Day 60 and Day 90
Secondary outcome [2] 320670 0
Secondary outcome 2: Mean system usability score as measured by the System Usability Scale (five-point Likert scale response ‘strongly disagree’ to ‘strongly agree’).
Timepoint [2] 320670 0
Secondary outcome 2:
Day 90 only
Secondary outcome [3] 320671 0
Secondary outcome 3: Google Analytics
* The number of participants.
* Geographical location (postcode) of participant’s IP address.
* The average number of page views per participant – a high number would indicate that the average participants go deep inside the site, possibly because they like it or find it useful.
* Average visit duration – the total length of a participant’s visit.
* Average page duration – how long a page is viewed for.
* Busy times – the most popular viewing time of the site.
* Most requested pages – the most popular pages.
* Most requested entry pages – the entry page is the first page viewed by a visitor and shows which are the pages most attracting visitors.
* Most requested exit pages – the most requested exit pages could help find bad pages or the exit pages may have a popular external link.
* Top paths – a path is the sequence of pages viewed by visitors from entry to exit, with the top paths identifying the way most visitors go through the site.
Timepoint [3] 320671 0
Secondary outcome 3:
Automatically collected throughout the entire duration of the trial.

Eligibility
Key inclusion criteria
Each participant must meet all of the following criteria to be enroled in the study:
* Aged 16 to 25 years old;
* Currently live in the NSW target communities of the Central Coast, Western Sydney or Far West;
* Regular access to a smartphone (iPhone or Android) and the Internet; and,
* Willingness to give online informed consent and willingness to comply with study protocol.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Due to the naturalistic research design, this study does not have defined exclusion criteria.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation
The naturalistic study will involve a total of 300 participants (n = 100 each from the Central Coast, Western Sydney and Far West) which is ample given calculations predict a total of 151 participants based on a small effect size (d=0.25) for three groups, an alpha level of 0.05 and 95% power for a repeated measures MANOVA design as well as accounting for an anticipated attrition rate of 30%.

Population to be analysed
The population to be analysed are young people aged 16 to 25 years currently living in the NSW target communities of the Central Coast, Western Sydney and the Far West. This population also has regular access to a smartphone (iPhone or Android) as well as the Internet and are interested in actively improving their general health and wellbeing (including mental health).

Statistical Analysis Plan
Utilising a naturalistic research design, the NSW Synergy Online Ecosystem will be evaluated by using a range of descriptive and multivariate statistical analyses, which will essentially look at baseline vs post-test outcomes. Further, longitudinal repeated measures MANOVA will be used to assess primary and secondary outcomes. Finally, where combinations of influential variables are identified, regression analyses will be used to identify the unique variance associated with different factors.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/02/2016
Actual
6/03/2016
Date of last participant enrolment
Anticipated
1/07/2016
Actual
1/07/2016
Date of last data collection
Anticipated
30/09/2016
Actual
12/11/2016
Sample size
Target
300
Accrual to date
Final
449
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292826 0
Government body
Name [1] 292826 0
Mental Health Commission of NSW
Country [1] 292826 0
Australia
Funding source category [2] 292827 0
Government body
Name [2] 292827 0
Young and Well Cooperative Research Centre
Country [2] 292827 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Brain and Mind Centre
100 Mallett Street
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 291569 0
None
Name [1] 291569 0
Address [1] 291569 0
Country [1] 291569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294333 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 294333 0
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006
Ethics committee country [1] 294333 0
Australia
Date submitted for ethics approval [1] 294333 0
08/12/2015
Approval date [1] 294333 0
15/01/2016
Ethics approval number [1] 294333 0
2015/946

Summary
Brief summary
The NSW Synergy Online Ecosystem is a new and innovative web-based resource of integrated apps and etools designed to help young people (aged 16 to 25 years) manage their general health and wellbeing (including mental health). If needed, the NSW Synergy Online Ecosystem also provides a seamless transition into web-based (or face-to-face) primary care.

The study will employ a naturalistic research design wherein potential participants (young people aged 16 to 25 years; living in the NSW target communities on the Central Coast, Western Sydney or the Far West; with regular access to a smartphone [iPhone or Android] and the Internet) will be given access to the NSW Synergy Online Ecosystem.

Participants will be given access to the NSW Synergy Online Ecosystem for a period of 90 days only. Participants are then able to navigate the website (or online system) at their own accord, naturally engaging with the recommended apps and etools. At five time points (Day 1, Day 15, Day 30, Day 60 and Day 90), participants will be asked to complete a short questionnaire via LimeSurvey. This questionnaire will include items regarding engagement with, efficacy and effectiveness of the website (or online system).
Trial website
www.nswsynergytrial.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63322 0
Prof Ian Hickie
Address 63322 0
Brain and Mind Centre
The University of Sydney
Building F, Level 4
94 Mallett Street
Camperdown NSW 2050
Country 63322 0
Australia
Phone 63322 0
+61 2 9351 0810
Fax 63322 0
Email 63322 0
[email protected]
Contact person for public queries
Name 63323 0
Ms Tracey Davenport
Address 63323 0
Brain and Mind Centre
The University of Sydney
Building G, Level 3
100 Mallett Street
Camperdown NSW 2050
Country 63323 0
Australia
Phone 63323 0
+61 2 9114 4220
Fax 63323 0
Email 63323 0
[email protected]
Contact person for scientific queries
Name 63324 0
Ms Tracey Davenport
Address 63324 0
Brain and Mind Centre
The University of Sydney
Building G, Level 3
100 Mallett Street
Camperdown NSW 2050
Country 63324 0
Australia
Phone 63324 0
+61 2 9114 4220
Fax 63324 0
Email 63324 0
[email protected]

No information has been provided regarding IPD availability


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.