Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001323718
Ethics application status
Approved
Date submitted
5/10/2022
Date registered
12/10/2022
Date last updated
12/10/2022
Date data sharing statement initially provided
12/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Co-designing a healthy lifestyle programme for first episode psychosis patients
Scientific title
Co-designing a healthy lifestyle programme for first episode psychosis patients by understanding the lived experiences of young people living with first episode psychosis
Secondary ID [1] 308114 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First episode psychosis 327820 0
Physical inactivity 327821 0
Substance use 327850 0
Smoking behaviour 327851 0
Condition category
Condition code
Mental Health 324895 324895 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A series of workshop sessions with service users, their families, and health service providers. We will be collecting qualitative data to inform the co-design of a healthy lifestyle programme.

Workshop 1 with service users only will last approx. 4 hours, to be conducted at the University of Otago Wellington, 29 Brandon Street, Lambton Quay, Wellington. This will be a semi-structured 'creative' session used to understand lived experience of psychosis within the healthcare system, identify barriers and facilitators to positive health behaviours, and initially design a system of support for positive health.

Workshop 2 with their families only will last approx. 2 hours, to be conducted online (Zoom). This workshop will be in the form of a focus group, exploring the same areas as Workshop 1 but from the perspective of family members.

Workshop 3 with service providers only will last approx. 2 hours, to be conducted at Early Intervention Services Wellington, Hania Street, Wellington, New Zealand. This workshop will focus on integrating design ideas with known contextual constraints within the healthcare system.

Workshop 4 with service users only will last approx. 1 hour, to be conducted online (Zoom). This workshop will focus on presenting a final system or programme of support to service users to obtain data regarding acceptability and feasibility

All workshops will be facilitated by three members of the research team: A member of Toi Tangata (a Maori-led health promotion agency specialising in co-design), an assistant research fellow, and a research assistant.
Intervention code [1] 324568 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332704 0
Determining perceived barriers and enablers during the co-design process via semi-structured workshops with service users, their family, and health service providers.
Timepoint [1] 332704 0
3 months after workshops completed
Secondary outcome [1] 414408 0
Service users' perceived autonomy.

Measured using a modified version of the Healthcare Climate Questionnaire (HCCQ).
Timepoint [1] 414408 0
Immediately following the final workshop,
Secondary outcome [2] 414691 0
Perceived confidence in changes to healthcare being made as a result of the co-design process.

Measured using a rating scale:
'On a scale of 1-10, how confident are you that changes to your healthcare will be made as a result of this co-design process?'
Timepoint [2] 414691 0
Immediately following the final workshop.
Secondary outcome [3] 414692 0
Acceptability of the co-design process

Measured using a rating scale:
'On a scale of 1-10, how acceptable did you find the co-design process?'
Timepoint [3] 414692 0
Immediately following the final workshop.

Eligibility
Key inclusion criteria
Current clients of Early Intervention Services (16 to 25 years old); stable mental state; able to provide informed consent, as determined by client’s case worker.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not acutely psychotic (as determined by each participant’s early intervention services clinician); not currently under the Mental Health Act.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
We are aiming to recruit 12 service users, 12 family members of service users, and 12 service providers. There are no statistical analyses involved, and therefore no power calculations for sample size required.

This is both prospective and retrospective because we have so far recruited 6 service users and no other participants, and the co-design process has yet to begin.

Data will be used to understand the lived experiences of young people experiencing first episode psychosis in terms of maintaining positive health behaviours.

We will collect data in the form of verbatim quotes and audio recording, and use a thematic analysis approach to analyse the data collected during workshops.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/09/2022
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
36
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 25044 0
New Zealand
State/province [1] 25044 0
Wellington

Funding & Sponsors
Funding source category [1] 312369 0
Charities/Societies/Foundations
Name [1] 312369 0
Lottery Health Research Grant
Country [1] 312369 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Level 4, 29 Brandon Street
Lambton Quay
Wellington
6011
Country
New Zealand
Secondary sponsor category [1] 313934 0
Charities/Societies/Foundations
Name [1] 313934 0
Lottery Health Research Grant
Address [1] 313934 0
c/o Department of Internal Affairs
45 Pipitea Street, Thorndon, Wellington 6011
Country [1] 313934 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311729 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 311729 0
Ethics committee country [1] 311729 0
New Zealand
Date submitted for ethics approval [1] 311729 0
08/04/2022
Approval date [1] 311729 0
02/05/2022
Ethics approval number [1] 311729 0
H22/048

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

Contacts
Principal investigator
Name 122158 0
Dr Matthew Jenkins
Address 122158 0
University of Otago Wellington
Level 5, 29 Brandon Street
Lambton Quay
Wellington
6011
Country 122158 0
New Zealand
Phone 122158 0
+64 221740904
Fax 122158 0
Email 122158 0
[email protected]
Contact person for public queries
Name 122159 0
Matthew Jenkins
Address 122159 0
University of Otago Wellington
Level 5, 29 Brandon Street
Lambton Quay
Wellington
6011
Country 122159 0
New Zealand
Phone 122159 0
+64 221740904
Fax 122159 0
Email 122159 0
[email protected]
Contact person for scientific queries
Name 122160 0
Matthew Jenkins
Address 122160 0
University of Otago Wellington
Level 5, 29 Brandon Street
Lambton Quay
Wellington
6011
Country 122160 0
New Zealand
Phone 122160 0
+64 221740904
Fax 122160 0
Email 122160 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17264Study protocol    384775-(Uploaded-05-10-2022-12-26-17)-Study-related document.docx
17265Informed consent form    384775-(Uploaded-05-10-2022-12-27-14)-Study-related document.pdf
17266Ethical approval    384775-(Uploaded-05-10-2022-12-28-34)-Study-related document.pdf



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.