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Trial registered on ANZCTR


Registration number
ACTRN12618000134224
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
30/01/2018
Date last updated
1/11/2019
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
1/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Coordinated Veterans' Care Pilot to improve mental health of Australian veterans
Scientific title
Coordinated Veterans' Care Pilot to improve mental health of Australian veterans
Secondary ID [1] 293784 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CVC Mental Health Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 306179 0
Condition category
Condition code
Mental Health 305292 305292 0 0
Anxiety
Mental Health 305293 305293 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CVC mental health program will include a digital coaching program known as Clevertar digital coaches, and a call monitoring facility provided by Tunstall Healthcare.

i) Clevertar digital coaches - mental health module
This program involves using an “app” for about 6 to 9 weeks per module. The module consists of 12 sessions, with a new coaching session available every 3 days. Each session lasts approximately 15 minutes. However, participants may choose to use the “app” for a longer period of time if they wish to revise the materials that they have read. Further, they can choose to access the “app” at any time at your convenience. Participants will have access to the mental health “app” module for 90 days.
The module uses low intensity cognitive behaviour therapy (Li-CBT) to guide goal setting and self-management for mild to moderate anxiety and depression. The mental health “app” module uses a virtual coach to provide individuals with the skills and strategies needed to maximise self-determination, and supports them to recognise and take responsibility for their own recovery and well being. Training to use the “app” will not be provided but participants can contact the Tunstall Healthcare for assistance if they have any difficulties while using the “app”.
Adherence will be assessed based on data capture included in the “app”. These include time spent during each session, time for completion, types of problems encountered etc.

ii) Clinical and technical support provided by Tunstall Healthcare
Tunstall will then call the participants every fortnight to provide them with any technical or clinical support that they need while using the “app”. Additionally, participants can contact the Tunstall call monitoring facility for any technical or clinical support during the hours of 9am-5pm Monday to Friday.
Intervention code [1] 300037 0
Treatment: Other
Comparator / control treatment
No comparator group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304449 0
Kessler Psychological distress (K-10) score
Timepoint [1] 304449 0
Baseline, 1- and 6-months post completion of the app
Secondary outcome [1] 342004 0
Pain Catastrophizing Scale (PCS)
Timepoint [1] 342004 0
Baseline, 1- and 6-months post completion of the app
Secondary outcome [2] 342005 0
Defence & Veterans Pain Rating Scale (DVPRS)
Timepoint [2] 342005 0
Baseline, 1- and 6-months post completion of the app
Secondary outcome [3] 342006 0
Dimensions of Anger Reactions Scale-5 (DAR-5)
Timepoint [3] 342006 0
Baseline, 1- and 6-months post completion of the app
Secondary outcome [4] 342007 0
Hope Scale
Timepoint [4] 342007 0
During app use (Sessions 1, 4, 8 and 12)


Eligibility
Key inclusion criteria
1) Have a Kessler Psychological distress (K-10) score between 20 and 29 at study entry;
2) Have chronic pain symptoms (chronic pain being defined as pain lasting more than 12 weeks) or other physical comorbidity;
3) Diagnosis of depression, anxiety or post-traumatic stress disorder (PTSD); and
4) Ability to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Persons with K-10 scores outside the 20 to 29 range;
2) Persons participating in another mental health research project;
3) Persons with a drug or alcohol use disorder; and
4) Hospitalisation with a mental health condition within the past 12 months.

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
The primary efficacy endpoint is the difference (d) in K-10 scores. A paired t-test will be used to compare the difference in an individual’s K-10 score at follow-up (1 and 6 months post completion of the app) with their baseline K-10 score. McNemar’s test will be used to compare measures with ordinal or categorical scale between baseline and 1 month follow-up.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298400 0
Government body
Name [1] 298400 0
Australian Government Department of Veterans’ Affairs
Address [1] 298400 0
21, Genge St,
Canberra ACT 2601
Country [1] 298400 0
Australia
Primary sponsor type
Government body
Name
Australian Government Department of Veterans’ Affairs
Address
21, Genge St,
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 297531 0
None
Name [1] 297531 0
Address [1] 297531 0
Country [1] 297531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299394 0
Departments of Defence and Veterans’ Affairs Human Research Ethics Committee
Ethics committee address [1] 299394 0
21 Genge St,
Canberra ACT 2601
Ethics committee country [1] 299394 0
Australia
Date submitted for ethics approval [1] 299394 0
24/10/2017
Approval date [1] 299394 0
08/12/2017
Ethics approval number [1] 299394 0
020-17
Ethics committee name [2] 299396 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 299396 0
101 Currie St,
Adelaide SA 5001
Ethics committee country [2] 299396 0
Australia
Date submitted for ethics approval [2] 299396 0
11/12/2017
Approval date [2] 299396 0
12/12/2017
Ethics approval number [2] 299396 0
200821

Summary
Brief summary
The Australian Government Department of Veterans' Affairs is expanding the current Coordinated Veterans’ Care (CVC) program to address the specific needs of veterans. The existing CVC program uses a team-based model of care led by a general practitioner (GP) and supported by a practice nurse. The GP and practice nurse, in consultation with the patient, develop a personalised care plan for the patient and then work with the patient to improve the management of the patient’s health and quality of life.

In the expanded CVC program to address mental health needs, the program will incorporate a digital mental health coaching program to support veterans with mild to moderate anxiety or depression. The digital mental health coaching program is known as Clevertar™ Digital Coaches “app”. Veterans using the “app” will also be supported by a call monitoring facility run by Tunstall Healthcare. The call monitoring facility will provide on-going support for veterans during the time they are using the Clevertar™ Digital Coach program. Staff at the call facility include mental health nurses, allowing participants to access immediate care and support.

The aim of this pilot is to evaluate whether the CVC mental health program for veterans with chronic pain who also demonstrate signs of mild to moderate mental health problems can improve mental health (as measured by psychological distress).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80266 0
A/Prof Nicole Pratt
Address 80266 0
Quality Use of Medicines and Pharmacy Research Centre,
School of Pharmacy and Medical Sciences
Sansom Institute for Health Research
University of South Australia
Adelaide SA 5001
GPO Box 2471
Country 80266 0
Australia
Phone 80266 0
+61 8 830 22818
Fax 80266 0
Email 80266 0
Nicole.Pratt@unisa.edu.au
Contact person for public queries
Name 80267 0
Dr Renly Lim
Address 80267 0
Quality Use of Medicines and Pharmacy Research Centre,
School of Pharmacy and Medical Sciences
Sansom Institute for Health Research
University of South Australia
Adelaide SA 5001
GPO Box 2471
Country 80267 0
Australia
Phone 80267 0
+61883022307
Fax 80267 0
Email 80267 0
Renly.Lim@unisa.edu.au
Contact person for scientific queries
Name 80268 0
Dr Renly Lim
Address 80268 0
Quality Use of Medicines and Pharmacy Research Centre,
School of Pharmacy and Medical Sciences
Sansom Institute for Health Research
University of South Australia
Adelaide SA 5001
GPO Box 2471
Country 80268 0
Australia
Phone 80268 0
+61883022307
Fax 80268 0
Email 80268 0
renly.lim@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The individual participant data will be kept at the Australian Government Department of Veterans’ Affairs. Restrictions apply to the availability of these data, and are not publicly available.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary