ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

First episode psychosis

Physical inactivity

Substance use

Smoking behaviour

Condition category

Condition code

Mental Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

3 months after workshops completed

Secondary outcome [1]

Service users' perceived autonomy.

Measured using a modified version of the Healthcare Climate Questionnaire (HCCQ).

Timepoint [1]

Immediately following the final workshop,

Secondary outcome [2]

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]

Immediately following the final workshop.

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Lottery Health Research Grant

Address [1]

c/o Department of Internal Affairs
45 Pipitea Street, Thorndon, Wellington 6011

Country [1]

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]

Charities/Societies/Foundations

Name [1]

Lottery Health Research Grant

Address [1]

c/o Department of Internal Affairs
45 Pipitea Street, Thorndon, Wellington 6011

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

Academic Committees Office
Te Tari ka Komiti Matauraka
Academic Division
University of Otago
PO Box 56, Dunedin 9054

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/04/2022

Approval date [1]

02/05/2022

Ethics approval number [1]

H22/048

Summary

Brief summary

Background
Young people experiencing first episode psychosis (FEP) have an increased risk of physical health conditions, which only worsen over time. These risks are due to a myriad of reasons, most notably the side effects of medication, but also notable effects on health behaviours such as physical activity, nutrition and/or rates of smoking, and substance use or abuse.
Young people experiencing FEP are faced with barriers to undertaking positive health behaviours, including sedation as a result of medication, reduced motivation and/or confidence, self- and societal stigma, and a lack of systemic support to lead healthy lives. While movements in other countries have developed ways to support young people with FEP to overcome these barriers, such efforts in Aotearoa New Zealand are scarce.

Purposes of the study
1.	To understand the lived experiences of young people experiencing first episode psychosis from the perspectives of the clients themselves and their whanau support.
2.	To co-design a healthy lifestyle programme that can be delivered within early intervention health services alongside FEP clients, their whanau/support, and health service professionals working with this population.

Methods
A series of iterative workshops will be undertaken in which FEP clients, their whanau/support, and health professionals (in the form of a expert advisory group) will work together to co-design a feasible healthy lifestyle programme, facilitated by members of the research team with lived experience of psychosis, and the Maori health promotion agency Toi Tangata.

Collected data in the form of verbatim quotes by participants, recorded audio, and data walls, will be analysed using a process of thematic analysis.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Matthew Jenkins

Address

University of Otago Wellington
Level 5, 29 Brandon Street
Lambton Quay
Wellington
6011

Country

New Zealand

Phone

+64 221740904

Fax

matthew.jenkins@otago.ac.nz

Contact person for public queries

Name

Matthew Jenkins

Address

University of Otago Wellington
Level 5, 29 Brandon Street
Lambton Quay
Wellington
6011

Country

New Zealand

Phone

+64 221740904

Fax

matthew.jenkins@otago.ac.nz

Contact person for scientific queries

Name

Matthew Jenkins

Address

University of Otago Wellington
Level 5, 29 Brandon Street
Lambton Quay
Wellington
6011

Country

New Zealand

Phone

+64 221740904

Fax

matthew.jenkins@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

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

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