Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000023257
Ethics application status
Approved
Date submitted
1/12/2017
Date registered
12/01/2018
Date last updated
22/10/2021
Date data sharing statement initially provided
22/10/2021
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Electronic risky health behaviour and mental health screening for contemporary NZ veterans
Scientific title
VeCHAT: Proof of concept study on screening, managing and monitoring NZ veterans’ health and wellbeing
Secondary ID [1] 293507 0
none
Universal Trial Number (UTN)
U1111-1206-0971
Trial acronym
VeCHAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 305693 0
Risky health behaviours 305694 0
Condition category
Condition code
Mental Health 304913 304913 0 0
Depression
Public Health 304914 304914 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic intervention study.
This is a proof of concept study. VeCHAT involves electronic screening of risky health behaviour and mental health screening for contemporary NZ veterans. Summary results are reviewed online by a Veteran Affairs medical case reviewer and referral made to a case manager where indicated. Veteran participants subsequently complete an online acceptability and feasibility survey. Case managers and medical case reviewers will be interviewed as to feasibility and acceptability of the tool, and utility data extracted from the VeCHAT database.
The only 'intervention' is the online screening. Participants will only be invited to complete the online screening once. The medical case reviewers will decide on the course of action as per their usual system of care ie usual practice. Similarly they will refer to the case managers as they would normally. The case managers will refer clients on, either for self-management, to community agencies or to GPs. they will not 'intervene' per se. Thew screening involves participants completing the online screening questionnaire at home or another place of their convenience on an internet-enabled device - eg computer, phone, tablet. Questions cover substance misuse, problem gambling, depression and anxiety, post-traumatic stress disorder, exposure to abuse, difficulties with anger control and physical inactivity., For some of the items a positive response triggers presentation of a validated scored diagnostic tool (ASSIST, PHQ-9, GAD-7, PTSD-PC). Completing the questionnaire takes between 5 and 15 minutes depending on numbers of positive responses.
Intervention code [1] 299819 0
Early detection / Screening
Intervention code [2] 299820 0
Lifestyle
Intervention code [3] 299821 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304107 0
Utility: VeCHAT response data extraction
Timepoint [1] 304107 0
Anonymous collated VeCHAT responses will be extracted from the programme at the end of data collection (estimated Dec 2019)
Primary outcome [2] 304189 0
Feasibility and acceptability from veterans' perspective - measured using post-VeCHAT survey
Timepoint [2] 304189 0
Electronic survey will be sent to veterans within two weeks of completing VeCHAT
Primary outcome [3] 304190 0
Feasibility and acceptability of VeCHAT from staff perspective. Measured using semi-structured interviews of medical case reviewers and case managers
Timepoint [3] 304190 0
Interviews will take place with case managers and medical case reviewers at the completion of data collection from the 200 veteran participants (estimated within one year of commencement of recruitment).
Secondary outcome [1] 341178 0
Feasibility and acceptability of VeCHAT from the perspective of support organisations. Interviews will be conducted with key members of No Duff and RSA to assess the feasibility and acceptability of VeCHAT as well as veteran recruitment procedure.

.
Timepoint [1] 341178 0
Once recruitment is complete (anticipated approximately Dec 2018)

Eligibility
Key inclusion criteria
Contemporary NZ Veteran
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Mixed methods with both qualitative analyses (primarily inductive thematic approach) and the gathering of quantitative descriptive data from the eCHAT tool.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/03/2018
Actual
1/03/2018
Date of last participant enrolment
Anticipated
28/02/2019
Actual
28/02/2019
Date of last data collection
Anticipated
31/03/2019
Actual
31/03/2019
Sample size
Target
200
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 9407 0
New Zealand
State/province [1] 9407 0
national

Funding & Sponsors
Funding source category [1] 298126 0
Government body
Name [1] 298126 0
Veterans Health Advisory Panel / Veterans AFfairs NZ
Country [1] 298126 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019, Auckland 1142
NZ
Country
New Zealand
Secondary sponsor category [1] 297282 0
None
Name [1] 297282 0
Address [1] 297282 0
Country [1] 297282 0
Other collaborator category [1] 279843 0
Government body
Name [1] 279843 0
Veterans Affairs NZ
Address [1] 279843 0
PO BOX 5146
Wellington 6410
Country [1] 279843 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299143 0
Health and Disability Ethics Committee
Ethics committee address [1] 299143 0
133 Molesworth Street, Wellington, NZ 6011
Ethics committee country [1] 299143 0
New Zealand
Date submitted for ethics approval [1] 299143 0
02/10/2017
Approval date [1] 299143 0
28/11/2017
Ethics approval number [1] 299143 0
17/CEN/224

Summary
Brief summary
This is a proof of concept study, assessing the acceptability, feasibility, and usability of eCHAT for the assessment and clinical care of veterans (VeCHAT). Results will also be used to gain NZ-specific data on the prevalence of mental health issues and lifestyle risk factors in veterans, thus informing future service delivery and policy.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
n/a
Attachments [1] 2238 2238 0 0
/AnzctrAttachments/374097-HDEC Letter 17CEN224_Approved EXP Application.pdf (Ethics approval)

Contacts
Principal investigator
Name 79446 0
Prof Felicity Goodyear-Smith
Address 79446 0
Department of General Practice & Primary Health Care, Room 378, Building 730 School of Population Health,Tamaki Campus, University of Auckland, 261 Morrin Rd, Glen Innes, Auckland 1142
Country 79446 0
New Zealand
Phone 79446 0
+64 9 923 2357
Fax 79446 0
Email 79446 0
[email protected]
Contact person for public queries
Name 79447 0
Prof Felicity Goodyear-Smith
Address 79447 0
Department of General Practice & Primary Health Care, University of Auckland, PB 92 019 Auckland 1142 New Zealand
Country 79447 0
New Zealand
Phone 79447 0
+6499232357
Fax 79447 0
Email 79447 0
[email protected]
Contact person for scientific queries
Name 79448 0
Dr Margot Darragh
Address 79448 0
Department of General Practice & Primary Health Care, University of Auckland, PB 92 019 Auckland 1142 New Zealand
Country 79448 0
New Zealand
Phone 79448 0
+6421337114
Fax 79448 0
Email 79448 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
Participants were assured privacy and confidentiality prior to participating in the study. Findings regarding the acceptability and feasibility of VeCHAT (the study aim) can be reported without providing individual data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes GOODYEAR-SMITH F, DARRAGH M, WARREN J. VeCHAT: a p... [More Details]

Documents added automatically
No additional documents have been identified.