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Trial registered on ANZCTR


Registration number
ACTRN12620000673943
Ethics application status
Approved
Date submitted
18/05/2020
Date registered
12/06/2020
Date last updated
12/06/2020
Date data sharing statement initially provided
12/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
MyCare: An Evaluation of a Community Based Mental Health Program for Individuals with a Mental Illness.
Scientific title
MyCare: effect of a Non-Randomised Controlled Trial of a Community Based Mental Health Program on Health and Wellbeing Outcomes Among Individuals with Severe Mental Illness
Secondary ID [1] 300841 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 316730 0
Psychosocial health 317672 0
Severe mental illness 317673 0
Condition category
Condition code
Mental Health 314975 314975 0 0
Psychosis and personality disorders
Mental Health 314976 314976 0 0
Schizophrenia
Mental Health 314977 314977 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MyCare Intervention.

Participants in the intervention group will receive the MyCare program, which is a step-down, community-based mental health programs that provide assertive outreach support to individuals aged 18-64 years-old with serious mental illness (SMI) who are also actively case managed by Mental Health Services (MHS) Tasmania (part of Department of Health in Tasmania). The intervention focuses on improving mental health issues and psychosocial adjustment (i.e., emotional, social, physical and spiritual dimensions of health) during administration of a 12 month program, with subsequent follow-up sessions up to 18 months post-enrolment. At the point of referral, a MyCare Senior Practitioner assesses the eligibility of the individual (i.e., aged 18-64, are motivated to change, and engaged with MHS). If eligible, MyCare clients are allocated a case worker (i.e., MyCare Care Coordinators) who provide home visitations on a weekly or fortnightly basis (depending on the client’s needs) for 1-2 hours (again, depending on the client's needs). The home visits aim to assist the client in setting and achieving their own personalised psychosocial goals to improve quality of life (i.e., safe and stable housing, physical health, community engagement, and independent living skills etc). The activities that are conducted during home visits will be varied, depending on the clients' needs. For example, Care Coordinators may accompany clients while grocery shopping to assist in improving eating habits, provide transport to mental health appointments, accompany the client on a walk in the park to facilitate behavioural activation, provide verbal psycho-education, or assist the client in completing forms, such as Centrelink applications. MyCare also incorporates a brokerage component, which is an enabler that can be used to assist in funding activities to reach clients’ psychosocial goals (i.e., gym membership) or to provide the client with basic living necessities (i.e., washing machine). Clients will not be provided with any physical or informational educational materials. To monitor adherence to the intervention, Care Coordinators will keep a record of when home visits are conducted with each client and a brief overview of what was achieved during each home visit, which will be kept in the client's file. Participants will also receive the control treatment as described below in addition to the MyCare program. Participants will attend a one-hour face-to-face session with the MHS psychiatrist every month for 12 months at the outpatient clinic at either the Royal Hobart Hospital or Launceston General Hospital, depending on the participants' location.
Intervention code [1] 317168 0
Lifestyle
Intervention code [2] 317169 0
Behaviour
Comparator / control treatment
Mental Health Services support
Individuals aged 18-64 years-old with a SMI who are on a ‘Treatment Order’ for Tasmanian State-wide Mental Health Services (MHS) support, will comprise the control group. MHS is operated through Tasmanian DHHS, and provides individuals with ongoing clinical assessment, treatment, and support to manage their mental illness for a period of 12 months. Participants will attend a one-hour face-to-face session with the MHS psychiatrist every month for 12 months. These will take place at the outpatient clinic at the Royal Hobart Hospital and Launceston General Hospital, depending on the location of the participant. Individuals on a treatment order were selected to comprise the control group as they are not likely to be engaged in any other community-based programs and will therefore not be actively receiving any other specific psychosocial support other than the compulsory clinical support from MHS, enabling a less contaminated comparison. Attendance will be routinely recorded as part of participants' treatment order and to assess adherence. Participants may be provided with physical or information materials for them to take home and consolidate what was covered in the session (e.g., educational documents about symptoms or medication management).
Control group
Active

Outcomes
Primary outcome [1] 323283 0
Psychosocial functioning is the composite primary outcome. It will be measured by The Behavioural and Symptom Identification Scale (BASIS-32), Health of the Nations Outcome Scales (HoNOS), and the Life Skills Profile (LSP-16)
Timepoint [1] 323283 0
Data will be collected at baseline (intake), every 13 weeks during the program, 12 months (closure, primary endpoint), and at 3 months and 6 months follow-up.
Secondary outcome [1] 381430 0
Hospital admissions assessed from patients' medical records
Timepoint [1] 381430 0
Data will be collected at baseline (intake), every 13 weeks during the program, 12 months (closure), and at 3 months and 6 months follow-up.
Secondary outcome [2] 381431 0
Fidelity - Care coordinators will complete a fidelity survey assessing the number, duration, and frequency of home visits,
Timepoint [2] 381431 0
Data will be collected at 12 months.
Secondary outcome [3] 383443 0
Length of stay- assessed from patients' medical records
Timepoint [3] 383443 0
Data will be collected at baseline (intake), every 13 weeks during the program, 12 months (closure), and at 3 months and 6 months follow-up.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion in this study if they are aged 18-64 years-old, diagnosed with a serious mental illness (SMI), reside in Tasmania, are currently case managed by MHS, and are able to provide informed consent.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are not actively case managed by MHS nor diagnosed with a SMI will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations will be conducted using G*Power. Systematic reviews of comparable interventions have found small - medium effects for post intervention outcomes, including mental health, and functioning. With the alpha set at .05, correlation, between repeated measures set at .50 and power of .80, a total sample of 165 individuals will be required (across all groups). However, to account for attrition and drop out, 200 participants will be needed.

A total of 6 mixed effects models will be run to examine the primary and secondary outcomes. The models will be run including fixed and random effects. For the dichotomous variables (i.e., sex, hospital admissions) a logistic mixed-effects model will be run to examine if there is a change in the outcomes over time. For the continuous variables (i.e., hospital duration and psychosocial outcomes from the BASIS-23, HoNOS, and LSP 16), a binomial or poisson mixed-effects model will be run depending on the distribution of the data and how skewed it is. Please note that missing data does not undermine the application of mixed-effects analyses as it applies Maximum Likelihood Estimation (as opposed to ANOVA that employs listwise deletion for missing data).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 16152 0
Royal Hobart Hospital - Hobart
Recruitment hospital [2] 16153 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 29685 0
7000 - Hobart
Recruitment postcode(s) [2] 29686 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 305297 0
Charities/Societies/Foundations
Name [1] 305297 0
Baptcare Services Tasmania
Country [1] 305297 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 1, 43-51 Kanooka Grove
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 305659 0
None
Name [1] 305659 0
Address [1] 305659 0
Country [1] 305659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305637 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 305637 0
Ethics committee country [1] 305637 0
Australia
Date submitted for ethics approval [1] 305637 0
Approval date [1] 305637 0
22/11/2019
Ethics approval number [1] 305637 0

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

Contacts
Principal investigator
Name 101038 0
Dr Renee O'Donnell
Address 101038 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Grove
Clayton, VIC, 3168
Country 101038 0
Australia
Phone 101038 0
+61 0422984527
Fax 101038 0
Email 101038 0
renee.odonnell@monash.edu
Contact person for public queries
Name 101039 0
Melissa Savaglio
Address 101039 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Grove
Clayton, VIC, 3168
Country 101039 0
Australia
Phone 101039 0
+61467555145
Fax 101039 0
Email 101039 0
melissa.savaglio@monash.edu
Contact person for scientific queries
Name 101040 0
Melissa Savaglio
Address 101040 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Grove
Clayton, VIC, 3168
Country 101040 0
Australia
Phone 101040 0
+61467555145
Fax 101040 0
Email 101040 0
melissa.savaglio@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual findings are not of interest and no individual participant will be identified in the dissemination of the findings. Instead, only group findings (i.e., overall group patterns in the data) will be reported in any papers or reports to organisations generated from this research project.


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
SourceTitleYear of PublicationDOI
EmbaseMyCare study: protocol for a controlled trial evaluating the effect of a community-based intervention on psychosocial, clinical outcomes and hospital admission rates for adults with severe mental illness.2020https://dx.doi.org/10.1136/bmjopen-2020-040610
N.B. These documents automatically identified may not have been verified by the study sponsor.