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Trial registered on ANZCTR


Registration number
ACTRN12618002059246
Ethics application status
Approved
Date submitted
10/12/2018
Date registered
21/12/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability of WAKA - a new online support tool for people living with schizophrenia on paliperidone injection
Scientific title
Acceptability of a new online self-management tool (WAKA) for people living with
schizophrenia who are prescribed paliperidone injection
Secondary ID [1] 294058 0
Janssen internal ID: RRA20110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 306616 0
Condition category
Condition code
Mental Health 305714 305714 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
WAKA is a recently developed novel digital self-management tool which has been co-created with people living with schizophrenia and healthcare providers experienced in managing schizophrenia. WAKA is co-designed, which mean its development has been informed by insights from service users, support groups, clinicians and other health providers involved in caring for people living with schizophrenia. It aims to deliver self-management education and support as well as provide a social support network to people living with schizophrenia in New Zealand who are prescribed paliperidone injection. WAKA is available via web or app, on any device or operating system, and accessible to any user who can connect to the internet.

WAKA is a self-directed self-management tool. It offers a suite of easily accessible online resources including engagement, activation, goal setting and tracking of feelings, behaviours and activity. The tracking / monitoring function includes a symptom tracker on the app (online diary), access to a 24/7 helpline delivered by HomeCare Medical mental health nurses, a moderated social community of fellow service users, and self-management modules and resources.

The tool is centred around a private secure service user community that is moderated around the clock by a team of mental health professionals. WAKA’s key aim is to deliver engaging and interactive self-management tools and education to encourage and enable service users to achieve and stay active in their recovery.

Below are WAKA’s key components:

• 24/7 online peer support moderated by mental health clinicians
• one to one access to a mental health trained coaches
• an online diary for service users track and monitor their own physical and mental health;
• engaging educational material;
• a portal for service users to store their own clinical information or share information directly with their care team
• a HELP button for service users to push if they feel they require additional support outside of WAKA’s scope

The educational material provided is designed specifically for this study and has been reviewed by health professionals with expertise in this field.

WAKA is not a clinical or crisis management tool and is not intended to be used by participants in this way. Any concerns/ questions regarding the clinical care of users will be directed to the usual care team.

This study aims to evaluate the acceptability of the WAKA tool in people living with schizophrenia, who are treated with monthly paliperidone injection. People living with schizophrenia, who have been prescribed paliperidone long-acting therapy, will be invited to participate in the evaluation of the WAKA tool.. Participants will have the opportunity to use WAKA and provide feedback on the tool during the 6-month study. Participation and use of WAKA will be entirely voluntary and no particular frequency of use will be stipulated as the study is observational, with the aim of assessing acceptability of the WAKA tool.
Intervention code [1] 313206 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304793 0
Acceptability of the WAKA tool for individuals living with schizophrenia, who are treated with long-acting paliperidone injection

This will be assessed in 3 ways:
- Self-report questionnaire via an end of study survey. This will ask participants to rate how much they agree/ disagree with statements about how easy the WAKA tool was to use and how useful they found it for managing their health and treatment
- Automatic data generated from the WAKA tool. This will be information on number of log-ins, time spent on different functions of the app, % people using app after 6 months
- Semi-structured interview via telephone to feedback on experience of using the app
Timepoint [1] 304793 0
6-months- post enrolment
Secondary outcome [1] 343217 0
Self-reported treatment adherence to paliperidone injection

Assessed by a 1-item question "Are you still having paliperidone injection" Yes/No
If no, then participant can tick reasons for this (side effects, doctor change medication, no longer needed, don't like injections, didn't have any benefit, other)
Timepoint [1] 343217 0
6-months-post enrolment
Secondary outcome [2] 343218 0
Social connectedness and integration
This is a composite measure and will be assessed by the Health Education Impact questionnaire (HeiQ) - using the Social integration and support (5 items) and Skill and Technique Acquisition (4 items) domains.
Participants will rate these statements from 1-5
Timepoint [2] 343218 0
6-months post-enrolment

Eligibility
Key inclusion criteria
People living with schizophrenia, who have been prescribed paliperidone long-acting therapy, will be invited to participate.

To be eligible for inclusion in the study service users must:

• be aged 18-65 years,
• have a diagnosis of schizophrenia,
• currently reside in one of the locations served by the recruitment sites
• be on a paliperidone long-acting therapy
• have internet access and a device that can access the internet (e.g. a smartphone)
• have capacity to provide informed consent
• be able to read and understand English at a sufficient level to provide informed consent and participate in the study.

Enrolment onto the trial is open to service users who meet the above inclusion criteria and are under a Compulsory Treatment Order (CTO).

In order to manage any ethical concerns around this issue, DHB enrollers will make it explicitly clear to potential participants that enrolling onto the trial is entirely voluntary. Enrollers will assess the initial response of individuals under CTO and provide information accordingly for those who are interested in enrolling. DHB staff will explain the aim of the study and provide any safeguards to address any feelings of coercion by the service user.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Service Users will be excluded if they:
• do not have daily access to the internet
• are unable to use a mobile phone or computer due to physical disabilities affecting eyesight or dexterity or do not have cognitive ability to navigate digital programmes

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment - the study is not a randomised controlled trial. There is no control group - rather we are exploring patient acceptability of a new digital tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - not randomised. Participants will be recruited by study nurses who will identify potentially interested and eligible participants from the patients' care team(s).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Observational
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be summarised using descriptive statistics. Continuous variables will be described as numbers of observed and missing values, mean, standard deviation, median, minimum and maximum. Categorical variables will be described as frequencies and percentages.

All primary and secondary outcome measures will be first summarised using descriptive statistics, at baseline and at six months separately. Differences before and after the intervention will be tested using paired Student’s t-test for continuous variables, and simple Chi-square test for categorical variables. Non-parametric tests may be considered if the distribution of data are not normal. Consistency of the intervention effect between ethnic groups (e.g. Maori, Pacific and non-Maori non-Pacific), level of interaction with the tool, and other subgroup analyses will be explored using standard regression analyses if numbers are large enough to enable such analyses. Sub-group analyses of interest include age, duration of illness, access to a GP, employment status, and smartphone and internet access.

All qualitative data collected will be analysed using an inductive thematic approach. The interviews will be audio-recorded with the service users consent, transcribed verbatim and de-identified. The transcripts will be checked by the researcher to ensure the transcription was accurate. The transcript will then be analysed for themes. An inductive thematic analysis approach (Braun and Clarke) will be used to extract and describe the responses from participants and from healthcare professionals. According to Braun and Clarke the use of an inductive approach means the themes are strongly linked to the data rather than extracting data the fits the beliefs of the researcher.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/12/2018
Actual
Date of last participant enrolment
Anticipated
7/06/2019
Actual
Date of last data collection
Anticipated
27/12/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 9588 0
New Zealand
State/province [1] 9588 0

Funding & Sponsors
Funding source category [1] 298683 0
Commercial sector/Industry
Name [1] 298683 0
Janssen Pharmaceutical Companies (Johnson & Johnson New Zealand)
Country [1] 298683 0
New Zealand
Primary sponsor type
Individual
Name
Dr Lyndy Matthews
Address
Spoonful of Sugar Ltd,
UCL Business PLC,
The Network Building,
97 Tottenham Court Road,
London W1T 4TP
Country
United Kingdom
Secondary sponsor category [1] 297854 0
Individual
Name [1] 297854 0
Dr Amy Chan
Address [1] 297854 0
Spoonful of Sugar Ltd,
UCL Business PLC,
The Network Building,
97 Tottenham Court Road,
London W1T 4TP
Country [1] 297854 0
United Kingdom
Other collaborator category [1] 279934 0
Commercial sector/Industry
Name [1] 279934 0
Spoonful of Sugar Ltd,
Address [1] 279934 0
UCL Business PLC,
The Network Building,
97 Tottenham Court Road,
London W1T 4TP
Country [1] 279934 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299637 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 299637 0
Ethics committee country [1] 299637 0
New Zealand
Date submitted for ethics approval [1] 299637 0
30/10/2017
Approval date [1] 299637 0
26/01/2018
Ethics approval number [1] 299637 0
17/STH/217

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

Contacts
Principal investigator
Name 81122 0
Dr Lyndy Matthews
Address 81122 0
Spoonful of Sugar Ltd,
UCL Business PLC,
The Network Building,
97 Tottenham Court Road,
London W1T 4TP
Country 81122 0
United Kingdom
Phone 81122 0
+61417935333
Fax 81122 0
Email 81122 0
lyndy@lipsych.co.nz
Contact person for public queries
Name 81123 0
Lisa Toi
Address 81123 0
c/o Janssen
507 Mt Wellington Highway
Mt Wellington
Auckalnd 1060
Country 81123 0
New Zealand
Phone 81123 0
+6421796024
Fax 81123 0
Email 81123 0
lisatoi222@gmail.com
Contact person for scientific queries
Name 81124 0
Lyndy Matthews
Address 81124 0
Spoonful of Sugar Ltd,
UCL Business PLC,
The Network Building,
97 Tottenham Court Road,
London W1T 4TP
Country 81124 0
United Kingdom
Phone 81124 0
+61417935333
Fax 81124 0
Email 81124 0
lyndy@lipsych.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual level participant data will only be available in a de-identified form and shared with partner research organisation Spoonful of Sugar Ltd, who is responsible for data analysis. Data includes:DHB, Demographics (age, gender, ethnicity, time since diagnosis, smoking /living / employment situation, health conditions), participant feedback, adherence, social integration questionnaire scores
When will data be available (start and end dates)?
From study start - 11th December until study recruitment and follow-up finished
Available to whom?
Only to Spoonful of Sugar Ltd (who is doing the data analysis) and Melon Health who will store data securely on its servers. Aggregate data and findings will be shared at the end of the trial in the form of the study report.
Available for what types of analyses?
Quantitative data - descriptive data analysis. Participant feedback will be analysed thematically (qualitatively). Other data such as adherence and questionnaire data will be summarised quantitatively (e.g. means, medians, total scores) and then compared between study baseline and end (e.g. change in adherence)
How or where can data be obtained?
This will be passed to Spoonful of Sugar from the online secure server in a password protected data form


What supporting documents are/will be available?

No Supporting Document Provided



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.