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Trial registered on ANZCTR


Registration number
ACTRN12620000642987
Ethics application status
Approved
Date submitted
24/04/2020
Date registered
1/06/2020
Date last updated
1/06/2020
Date data sharing statement initially provided
1/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrating a mobile health device into a community youth mental health team to manage severe mental illness: A randomized controlled trial
Scientific title
A randomized controlled trial examining the effects of a mobile health device integrated into a community mental health team on illness severity and treatment response in young adults with severe mental illness
Secondary ID [1] 300659 0
None
Universal Trial Number (UTN)
Trial acronym
unWIRED-RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe mental illness 316126 0
Condition category
Condition code
Mental Health 314415 314415 0 0
Anxiety
Mental Health 314416 314416 0 0
Depression
Mental Health 314417 314417 0 0
Psychosis and personality disorders
Mental Health 314418 314418 0 0
Schizophrenia
Mental Health 314704 314704 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard case management augmented by a integrated mobile Health device (unWIRED intervention): Participants will receive case management for their mental illness through a community mental health service, as well as wearing the Embrace2 mobile Health (mHealth) device. Case management involves an assessment followed by combinations of medication-based and/or psychosocial treatments. Participants are assigned a core case manager, however, their treatment is managed within a mental health team. Frequency of contact with the mental health service varies based on clinical necessity, typically weekly to monthly contact. Contact with the mental health service can be through phone calls, face to face meetings at the community health center or home visits if required. In addition to receiving standard case management, a mHealth device will continuously record the participant's physiological measurements including actigraphy (rest and activity) and electrodermal activity (EDA). The Embrace2 mHealth device will be worn on the wrist for up to 6 months during the trial. The participants will have access to activity-based information which will be transmitted to their mobile phone. These measurements will be relayed to health service computers and displayed on dashboards for the treating case manager to view. The dashboard will provide a visualization of the participant's EDA and activity over a 24-hour period. Based on this information, case managers and/or participants may choose to alter their management plan. For example, periods of high arousal and/or poor sleep may indicate a need for a medication change or a more assertive intervention. Physiological information relayed to both the case manager and participant will be regularly reviewed and discussed during clinical team meetings.
Intervention code [1] 316754 0
Treatment: Devices
Intervention code [2] 317430 0
Prevention
Comparator / control treatment
Standard case management augmented by an unintegrated mobile health device (control): Participants in the control condition will receive their standard care in addition to being given a basic mHealth device (the Fitbit Inspire) to self-monitor their activity. This device will provide information to the participants regarding their activity, however, unlike the integrated condition, information will not be returned to their treating case manager - the device will not be integrated within the mental health team. The Fitbit Inspire also does not measure EDA. The device can be used at the participant's discretion, without prompting or oversight from their case manager. Measurements from the unintegrated device will not be recorded for the purposes of this research.
Control group
Active

Outcomes
Primary outcome [1] 322964 0
Clinical Global Impression Scale: The CGI severity scale is a measure of mental illness severity as reported by the participant's case manager and through chart review by a blind rater. The blind rater is independent and blinded to treatment allocation.
Timepoint [1] 322964 0
Measurements will be made at baseline, 1, 2, 3, 4, 5 and 6 months post intervention commencement.
Primary outcome [2] 322965 0
Clinical Global Impression Scale: The CGI treatment response scale is a measure of treatment efficacy as reported by the participant's case manager and through chart review by a blind rater. The blind rater is independent and blinded to treatment allocation.
Timepoint [2] 322965 0
Measurements will be made at baseline, 1, 2, 3, 4, 5 and 6 months post intervention commencement.
Primary outcome [3] 323613 0
Number of exacerbations of mental illness requiring emergency care: Exacerbations are evidenced by ratings from clinicians and blind independent raters using electronic Medical Records (eMR). Where necessary, case managers or participants will also be consulted to clarify clinical information from eMR. Charts will be examined for information including emergence of symptoms, treatment histories, hospitalizations, indications of relapse and mental deterioration.
Timepoint [3] 323613 0
This will be evaluated at 6-month post commencement of the trial.
Secondary outcome [1] 380387 0
The Depression Anxiety and Stress Scale 21 Item Version: The DASS-21 is a composite measure of current depression, anxiety and stress over the previous week.
Timepoint [1] 380387 0
Baseline and 6-month.
Secondary outcome [2] 380613 0
The Behavior and Symptom Assessment Scale 24 items: The BASIS-24 is a composite measure of psychiatric symptoms and functioning difficulties over the previous week.
Timepoint [2] 380613 0
Baseline and 6-month.
Secondary outcome [3] 380735 0
Activity and Participation Questionnaire: The APQ6 is a measurement of the participant's capacity to conduct their usual activities over the previous month.


Timepoint [3] 380735 0
Baseline, 3-month and 6-month.
Secondary outcome [4] 380736 0
The Assessment of Quality of Life 8 Dimension: The AQoL-8D is a health-related multi-attribute quality of life measure over the previous week.
Timepoint [4] 380736 0
Baseline and 6-month.
Secondary outcome [5] 380737 0
The Pittsburgh Sleep Quality Index: The PSQI is a composite measure of sleep quality and disturbances over the previous month.
Timepoint [5] 380737 0
Baseline, 3-month and 6-month.
Secondary outcome [6] 380739 0
Measurements regarding electrdoermal activity (EDA) will be made using the Embrace2 Device.

Timepoint [6] 380739 0
Continuously from study entry until 6 months post intervention commencement.
Secondary outcome [7] 382935 0
Measurements regarding actigraphy (rest and activity) will be made using the Embrace2 Device.
Timepoint [7] 382935 0
Continuously from study entry until 6 months post intervention commencement.
Secondary outcome [8] 382983 0
Participants in the integrated unWIRED intervention will be asked to report their stress levels in real time in order to identify periods when they are stressed or becoming unwell. Participants will receive a text message asking “How stressed are you feeling now?” (0 = not at all stressed; 10 = very stressed), what they are doing and/or how they are feeling. Participants will not respond to the text message, rather they will record their response on the Empatica Mate App, which is downloaded onto their phone. The event will be given a time stamp and recorded alongside their physiological data.
Timepoint [8] 382983 0
EMA scores will be recorded randomly from study entry until 6 months post intervention commencement. This will occur initially second daily and then reduce to weekly after the first 2 weeks.
Secondary outcome [9] 382984 0
Qualitative interviews regarding attitudes to the mHealth Intervention: For the participants in the integrated intervention and their respective case managers, feedback as to the acceptability of the approach will be obtained. Study researchers will collect information regarding participant and case manager attitudes towards the mHealth device. For example, participants and case managers will be asked what they find helpful or challenging about using the device. This information will be sort either from focus groups or individual interviews. The transcribed responses will be thematically analysed by members of the research team.
Timepoint [9] 382984 0
Qualitative interviews will be conducted at the 6 month conclusion of the trial.
Secondary outcome [10] 383069 0
The Social and Occupational Functioning Assessment Scale: The SOFAS is an overall measure of social and occupational functioning used in psychiatric assessments as reported by the participant's case manager. This will be done by an independent rater blind to treatment allocation.
Timepoint [10] 383069 0
Measurements will be made at baseline, 1, 2, 3, 4, 5 and 6 months post intervention commencement.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Current community mental health service patient
2. Aged 18-25 years
3. Confirmed diagnosis of serious mental illness, such as schizophrenia spectrum disorders, bipolar, major depressive disorder, anxiety and/or personality disorder
4. Capacity to consent to the study
Minimum age
18 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Non-English speaking
2. Greater than mild developmental disability
3. Inability to comply with either the requirements of informed consent or the treatment protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
When allocation has occurred, the participant's case manager will be informed which condition they are in. Participants will not be blinded to the allocation, as their involvement will be visible based on their device usage.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomly permuted blocks will be centrally generated using a computer-generated algorithm. Participants will be allocated independently of the researchers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The trial design is a parallel group randomized controlled trial, predicting the superiority of case management for severe mental illness with an integrated mHealth device over case management with an unintegrated device. It will have a mixed design with both between (case management with an integrated vs. unintegrated mHealth device) and within subject components (repeated measures of participants with the integrated device to determine if it predicts mental deterioration). Scoring of primary outcomes will be conducted by clinicians and independent raters who are blind to the participant’s treatment condition.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome for this study is to compare changes in treatment-related variables for participants in the integrated unWIRED condition vs. unintegrated control condition. The RCT component generally compares measures of mental health, distress and functioning between the conditions, adjusted for baseline scores. For example, this analysis may focus on an intent-to-treat using a hierarchical linear model (HLM) to test the differential effects of the two treatment conditions, because this method allows the number of observations to vary between participants and handles missing data by calculating estimates of trajectories using maximum likelihood estimation. Fixed effects could be tested for intervention condition and time of assessment. Random effects in the unstructured models provide an index of the relative effects of the treatments over time. Fixed effects parameters may be tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Analyses will focus on the primary (CGI scores, mental health exacerbations) and secondary outcomes (e.g., APQ, BASIS-24, DASS, Pittsburgh, SOFAS, AQoL-8D) between unWIRED and the active control, with the main outcome points being 6-month follow-up, relative to baseline. All results are based on estimated mean values derived from HLM analyses.

The within subjects analysis will conduct linear fixed effects models using physiological measurements (sleep, activity and EDA) to predict measures of mental health, distress and functioning. Baseline variables may be used as covariates when analyzing individual and between group differences (e.g., age, illness severity and personality differences).

Thematic analysis will be used to analyse individual and group qualitative feedback regarding the acceptability of the mHealth device and unWIRED intervention for participants and case managers.

Recruitment
Recruitment status
Not yet 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)
NSW
Recruitment hospital [1] 16817 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 30440 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 304873 0
Charities/Societies/Foundations
Name [1] 304873 0
Balnaves Foundation
Address [1] 304873 0
Suite 2, level 8/139
Macquarie St
Sydney, NSW, 2000.
Country [1] 304873 0
Australia
Funding source category [2] 305037 0
Government body
Name [2] 305037 0
Western Sydney Local Health District
Address [2] 305037 0
Westmead Hospital
Cnr Hawkesbury Road and Darcy Rd
Westmead, NSW, 2145, Australia.
Country [2] 305037 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Westmead Hospital
Cnr Hawkesbury Road and Darcy Rd
Westmead, NSW, 2145, Australia.
Country
Australia
Secondary sponsor category [1] 305462 0
None
Name [1] 305462 0
Address [1] 305462 0
Country [1] 305462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305281 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305281 0
Westmead Hospital
Cnr Hawkesbury Road and Darcy Rd
Westmead, NSW, 2145, Australia.
Ethics committee country [1] 305281 0
Australia
Date submitted for ethics approval [1] 305281 0
13/11/2019
Approval date [1] 305281 0
17/04/2020
Ethics approval number [1] 305281 0

Summary
Brief summary
Symptoms of mental illness are often triggered by stress and individuals with mental illness are sensitive to these effects. This study uses a mobile health device to monitor physiological signs of stress in youths with severe mental illness, as reflected by changes in their activity and arousal. Participants from community mental health services will be allocated to standard case management combined with an integrated mHealth device (information is viewed by both participant and case manager) or an unintegrated mHealth device (participant alone views information; control). We hypothesize that participants and case managers using the integrated mHealth device will be better able to engage and respond to early signs of mental deterioration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99874 0
Prof Anthony Harris
Address 99874 0
Department of Psychiatry
Cnr Hawkesbury Road and Darcy Rd
Westmead Hospital
Westmead, NSW, 2145.
Country 99874 0
Australia
Phone 99874 0
+61 2 88906688
Fax 99874 0
+61 2 96357734
Email 99874 0
anthony.harris@sydney.edu.au
Contact person for public queries
Name 99875 0
Prof Anthony Harris
Address 99875 0
Department of Psychiatry
Cnr Hawkesbury Road and Darcy Rd
Westmead Hospital
Westmead, NSW, 2145.
Country 99875 0
Australia
Phone 99875 0
+61 2 88906688
Fax 99875 0
+61 2 96357734
Email 99875 0
anthony.harris@sydney.edu.au
Contact person for scientific queries
Name 99876 0
Dr Simon Byrne
Address 99876 0
Department of Psychiatry
Cnr Hawkesbury Road and, Darcy Rd
Westmead Hospital
Westmead, NSW, 2145.
Country 99876 0
Australia
Phone 99876 0
+61 437253851
Fax 99876 0
+61 2 96357734
Email 99876 0
simon.byrne@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Provided that we can assure the privacy and confidentiality of the data, we will consider sharing it. All participant data requests will be considered.
When will data be available (start and end dates)?
At the conclusion of the trial for five years.
Available to whom?
Researchers who are interested.
Available for what types of analyses?
All types of analysis could be used.
How or where can data be obtained?
Data can be obtained by email request from the principal investigator, Prof Anthony Harris (anthony.harris@sydney.edu.au).
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 7774 0
Study protocol
Citation [1] 7774 0
Link [1] 7774 0
Email [1] 7774 0
anthony.harris@sydney.edu.au
Other [1] 7774 0
Attachment [1] 7774 0
Summary results
No Results