Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001676202
Ethics application status
Approved
Date submitted
2/08/2018
Date registered
11/10/2018
Date last updated
11/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Project Synergy: A Clinical Trial to Validate the Synergy Online System
Scientific title
Project Synergy: A Clinical Trial to Validate the Synergy Online System within Australian mental health services across the lifespan
Secondary ID [1] 294212 0
None
Universal Trial Number (UTN)
U1111-1221-7071
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 309941 0
Anxiety 309942 0
Other mental health disorders 309953 0
Condition category
Condition code
Mental Health 308714 308714 0 0
Depression
Mental Health 308715 308715 0 0
Anxiety
Mental Health 308716 308716 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Synergy Online System (Synergy) is a customisable digital toolkit to assist assessment, monitoring and management of mental health issues and maintenance of wellbeing. It does this by collecting personal and health information (data) from consumers and their service providers. This information is stored, analysed, and reported back to consumers and their health professionals to promote collaborative care partnerships. The clinical content is determined by the service provider who invited the consumer to use Synergy.

Synergy does not itself provide stand-alone medical or health advice, diagnosis or treatment. Instead, Synergy guides and supports (but does not direct) consumers and their treating health professionals to decide what may be suitable care options. Importantly, all care aligns with the existing clinical governance (e.g. policies and procedures) of the service provider.

The primary objective of this clinical trial is to validate, by provision of objective evidence, that Synergy can be implemented consistently and conforms to all user’s needs and intended uses as it pertains to "stage-based stepped-care".

Objective evidence for validation will be collected from Synergy, health professionals assessing consumers, in-service multi-disciplinary teams as well as an independent expert-clinician reference group. This data will be used for:

Scientific validity – showing the association of Synergy output to the prevention, early intervention, treatment and continuous monitoring of mental ill health and maintenance of wellbeing using "stage-based stepped-care";

Clinical performance – showing the ability of Synergy to yield a clinically meaningful output for individual users, health professionals and services associated to the target use of Synergy for the purposes of prevention, early intervention, treatment and continuous monitoring of mental ill health and maintenance of wellbeing; and

Analytical validity – showing the technical performance of Synergy related to the accuracy, reliability, repeatability and reproducibility of data and recommendations.

To conduct this clinical trial, Synergy will be implemented into traditional and online Australian mental health services (participating centres) to use as standard practice for a period of up to 12 months. After contacting a service for care, a consumer will be invited to use Synergy by the service. Following consent, the consumer will complete an immediate online self-report assessment (including demographics, medical and psychological history, current symptoms and functioning) and then view a dashboard of results with recommended care options that are self-managed (eg. apps, etools, fact sheets) or health professional supported (eg. psychological therapies). After the initial assessment and most commonly during the first face-to-face appointment, treating health professionals will review and interact with a consumers dashboard of results and recommended care options. They will also input data regarding the consumer’s overall health, severity of illness, observed levels of distress, function and risk. Importantly, Synergy will provide a recommendation of “staged-based stepped care” and the health professional as well as in-service multi-disciplinary team will provide their consensus to this recommendation. Separately, an independent expert-clinician reference group will review approximately 10% of the results to further validate “staged-based stepped care”.
Intervention code [1] 300503 0
Treatment: Other
Comparator / control treatment
In this clinical trial, there is no control group. However, there are four comparators:

1. Synergy recommended “staged-based stepped care” which is a generated via a prototypic algorithm within the system.
2. Trained health professional allocation of “staged-based stepped care” within Synergy which is provided as a consensus to Synergy’s prototypic algorithm.
3. In-service multi-disciplinary team allocation of “staged-based stepped care” within Synergy which is provided as a consensus to Synergy’s prototypic algorithm.
4. Independent expert-clinician reference group who are responsible for reviewing up to 10% of participating consumers/ health professional outcomes to further validate “staged-based stepped care” recommendations. They are the gold standard.
Control group
Active

Outcomes
Primary outcome [1] 305000 0
A primary outcome is the comparison of Synergy-generated assignment of "staged" to health professional allocation, within-service multidisciplinary team consensus as well as an independent expert-clinician reference group. Stage is measured as 1A (mild symptoms/ functional impairment), 1B (moderate symptoms/ functional impairment), 2 (diagnosed mental disorder), 3 (ongoing mental disorder) or 4 (severe & ongoing mental disorder).
Timepoint [1] 305000 0
1 month
Primary outcome [2] 307690 0
A primary outcome is the comparison of Synergy-generated assignment of "stepped care" to health professional allocation, within-service multidisciplinary team consensus as well as an independent expert-clinician reference group. Stepped care (or recommended level of care) is measured as Step 1 (maintenance of wellbeing), 2 (low need for support), 3 (moderate need for support), 4 (high need for support) or 5 (very high need for support).
Timepoint [2] 307690 0
1 month
Primary outcome [3] 307691 0
A composite primary outcome is the evaluation of an individual’s clinical and functional outcomes matched to their allocated "stage-based stepped care". Specifically, clinical and functional outcomes will be determined by one-item assessing overall health, the patient/ clinician global impression rating scale, the Kessler psychological distress scale (K10), SOFAS and the SIDAS. This data is collected by the consumer’s initial online self-report assessment (via Synergy) as well as the health professionals input regarding the consumer (also via Synergy).
Timepoint [3] 307691 0
1 month
Secondary outcome [1] 352594 0
Another primary outcome is to determine analytical validity using both Google and system analytics.

Google analytics will continuously measure: number of users by type of user; geographical location of user’s IP address; average number of page views per user; average visit duration; average page duration; busy times; most requested pages; most requested exit pages; external links; and top paths. System analytics will continuously measure the accuracy, reliability, repeatability and reproducibility of results shown on a consumer's dashboard. These will also be checked manually by a data analyst using defined statistical analyses.
Timepoint [1] 352594 0
1 month
Secondary outcome [2] 352674 0
A secondary outcome is to monitor Synergy for the purposes of quality assurance and improvement. This will be measured by consumer, health professional and service feedback collected via Synergy through online evaluation polls (i.e. the System Usability Scale).
Timepoint [2] 352674 0
3 months

Eligibility
Key inclusion criteria
Presenting for care to a traditional face-to-face or online mental health service utilising Synergy as part of their standard clinical care/ practice.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Due to the nature of its research design, this clinical trial 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
Scientific validity will be evaluated using inter-rater reliability statistical methods to quantify the degree of agreement within and between the four ratings of "stage-based stepped care" (i.e. Synergy-generated, health professional allocated, in-service multi-disciplinary consensus and independent expert clinician reference group).

The clinical performance of Synergy will be evaluated using: aggregate data derived from clinical rating scales completed by the individual user and health professional to measure and track health domain intensity, frequency, quality and chronicity over time; and, aggregate service-level performance data including safety and clinical quality (e.g. reduced time to first assessment, improved user service accessibility, reduced waitlist for service, greater service efficiency, improved service user satisfaction).

Within and between group analyses using multivariate statistics (e.g. multivariate analyses of variance, Kruskall Wallis test, etc.) will be computed to evaluate differences in clinical outcomes between services and between population groups. Additionally, reliable change and effect-size scores will be calculated to determine clinical improvement over time for individual data and then aggregated for service-level outcome data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 10979 0
Headspace Hurstville - Hurstville
Recruitment hospital [2] 10980 0
Headspace Miranda - Miranda
Recruitment hospital [3] 10981 0
Headspace Bondi Junction - Bondi Junction
Recruitment hospital [4] 10982 0
Headspace Ashfield - Ashfield
Recruitment hospital [5] 10983 0
Headspace Camperdown - Camperdown
Recruitment hospital [6] 10984 0
Headspace Port Macquarie - Port Macquarie
Recruitment hospital [7] 10985 0
Headspace Coffs Harbour - Coffs Harbour
Recruitment hospital [8] 10986 0
Headspace Grafton - Grafton
Recruitment hospital [9] 10987 0
Headspace Lismore - Lismore
Recruitment hospital [10] 10988 0
Headspace Tweed Heads - Tweed Heads
Recruitment hospital [11] 10989 0
Headspace Edinburgh North - Edinburgh North
Recruitment hospital [12] 10990 0
Veterans and Veterans Families Counselling Service - Surry Hills
Recruitment postcode(s) [1] 22779 0
2010 - Surry Hills
Recruitment postcode(s) [2] 22770 0
2022 - Bondi Junction
Recruitment postcode(s) [3] 22772 0
2050 - Camperdown
Recruitment postcode(s) [4] 22771 0
2131 - Ashfield
Recruitment postcode(s) [5] 22768 0
2220 - Hurstville
Recruitment postcode(s) [6] 22769 0
2228 - Miranda
Recruitment postcode(s) [7] 22773 0
2444 - Port Macquarie
Recruitment postcode(s) [8] 22774 0
2450 - Coffs Harbour
Recruitment postcode(s) [9] 22775 0
2460 - Grafton
Recruitment postcode(s) [10] 22776 0
2480 - Lismore
Recruitment postcode(s) [11] 22777 0
2485 - Tweed Heads
Recruitment postcode(s) [12] 22778 0
5113 - Edinburgh North

Funding & Sponsors
Funding source category [1] 298849 0
Government body
Name [1] 298849 0
Department of Health
Country [1] 298849 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 300416 0
None
Name [1] 300416 0
Address [1] 300416 0
Country [1] 300416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299793 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 299793 0
NSLHD Research Office
Reserve Rd
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 299793 0
Australia
Date submitted for ethics approval [1] 299793 0
10/07/2018
Approval date [1] 299793 0
02/08/2018
Ethics approval number [1] 299793 0
RESP/17/349

Summary
Brief summary
The Synergy Online System collects data via multiple sources including online self-report, health professional and service surveys as well as third-party integrations (e.g. Fitbit) as a means to offer individual user’s personalised assessment and intervention options as well as continuous monitoring. This research employs a naturalistic prospective clinical trial design wherein all individuals presenting for care to a traditional face-to-face or online mental health service (participating in Project Synergy research studies) will be informed of the trial via a tiered consenting process including 'opt-out'. Upon consent, Synergy collects, stores and analyses personal and health information (data) in its database. By taking part in this clinical trial, participants give researchers permission to access their non-identified data, which will be used to scientifically, clinically and analytically validate "stage-based stepped-care" recommendations generated by the System.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2938 2938 0 0
/AnzctrAttachments/374632-Letter - Approved AMENDMENT - HREC Exec Meeting 1 August 2018 - RESP_17_349.pdf

Contacts
Principal investigator
Name 81586 0
Prof Ian Hickie
Address 81586 0
The University of Sydney
Brain and Mind Centre
94 Mallett Street
Camperdown, NSW 2050
Country 81586 0
Australia
Phone 81586 0
+61 2 9351 0810
Fax 81586 0
Email 81586 0
ian.hickie@sydney.edu.au
Contact person for public queries
Name 81587 0
Ms Joan Torony
Address 81587 0
The University of Sydney
Brain and Mind Centre
InnoWell | Shop 1-3 | 66-70 Parramatta Road
Camperdown
NSW 2050
Country 81587 0
Australia
Phone 81587 0
+61 2 8627 7263
Fax 81587 0
Email 81587 0
joan.torony@sydney.edu.au
Contact person for scientific queries
Name 81588 0
Ms Tracey Davenport
Address 81588 0
The University of Sydney
Brain and Mind Centre
InnoWell | Shop 1-3 | 66-70 Parramatta Road
Camperdown
NSW 2050
Country 81588 0
Australia
Phone 81588 0
+61 2 8627 6932
Fax 81588 0
Email 81588 0
tracey.davenport@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23605Study protocolDavenport TA, LaMonica HM, Whittle L, English A, Iorfino F, Cross S, Hickie IB Validation of the InnoWell Platform: Protocol for a Clinical Trial JMIR Res Protoc 2019;8(5):e13955  
23606Clinical study report  haley.lamonica@sydney.edu.au

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.