Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000519156
Ethics application status
Approved
Date submitted
21/03/2019
Date registered
1/04/2019
Date last updated
1/04/2019
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of using a smartphone app and clinician portal to encourage and support healthy living behaviours for people with mental illness
Scientific title
Participatory and personalised mHealth platform to encourage and support healthy living behaviours for people with mental illness_Feasibility study
Secondary ID [1] 297710 0
Nil
Universal Trial Number (UTN)
Trial acronym
Health-e Minds
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serious mental illness 312022 0
Condition category
Condition code
Mental Health 310583 310583 0 0
Addiction
Mental Health 310584 310584 0 0
Anxiety
Mental Health 310585 310585 0 0
Depression
Mental Health 310586 310586 0 0
Schizophrenia
Mental Health 310587 310587 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Health-e Minds solution utilises technologies which integrate smartphones, the Internet, measurement devices and multimedia content to support persons with diagnosis of mental illness through encouraging healthy behaviours. Patients are able to monitor health parameters such as body weight, steps, exercise, symptoms, sleep, stress level, tobacco smoking and alcohol through the smartphone app. The app provides visual (graphical) and textual progress reports, and motivational messages and information to assist individuals in the management of their illness, such as links to professional guidelines regarding diet or exercise. The entries on the app automatically update to a web-based clinician portal. Participants are encouraged to enter their clinical measures at least once a day. The number of measures to be entered are personalised for each person, in consultation with their treating clinician, and therefore may differ. The portal enables clinical care providers to view their clients’ progress and provide individualised feedback and/or early care intervention dependent on the advice of the clinical review.
Clinicians from the Mental Health and Addiction Services, Sunshine Coast Hospital and Health Service (SCHHS) will identify potentially eligible participants from their existing clients. These individuals will be provided with the Information Sheet that describes the study requirements during scheduled information sessions with groups of patients. Face to face interviews with clinician/s of the clinical care team and individuals who indicate that they are interested in participating in the study will be conducted. The interviews will ensure that the prospective participants meet the inclusion criteria and are able to provide informed consent. During the interview, the clinical care team member will discuss the study with participants and their family members (if applicable) and will answer any questions that they may have.
Interested individuals will be asked to sign the Participant Consent Form and will be provided with a copy of the Information sheet and the signed consent form.
All consented participants will be registered by a member of their clinical care team in the Health-e Mind Clinician portal and will be given access to the Health-e Mind app through a portal generated username and password. Participants recruited into the study will receive their usual care and they will have access to the app for at least 12 weeks. They will be instructed by their health carer on how to use the App. During this study, participant data will be viewed through the Clinician web portal by one of three SCH clinical staff at least once per week, followed by a phone call. During the weekly phone call, any non-adherence to uploading data will be discussed in order to encourage adherence to the intervention. Participants will be asked to complete surveys at baseline and again after 12 weeks. These will include Demographic information, EQ5D, Kessler 10, 6 Minute Walk Test and User Experience survey.
Intervention code [1] 313947 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319438 0
Clinicians - User perceptions through semi-structured interviews during focus group. Questions for focus groups designed specifically for this study.
Timepoint [1] 319438 0
End of 12 week study
Primary outcome [2] 319616 0
Patient - User experience and satisfaction based on surveys designed specifically for this study.
Timepoint [2] 319616 0
End of 12 week study
Secondary outcome [1] 368202 0
Quality of life (EQ5D 5-L survey)
Timepoint [1] 368202 0
Baseline, 6 weeks and end of 12 week study
Secondary outcome [2] 368203 0
Depression (Kessler 10)
Timepoint [2] 368203 0
Baseline, 6 weeks and end of 12 week study
Secondary outcome [3] 368204 0
Functional capacity (6 Minute Walk Test)
Timepoint [3] 368204 0
Baseline, 6 weeks and end of 12 week study

Eligibility
Key inclusion criteria
Confirmed mental health illness treated at Sunshine Coast Health
Proficiency in spoken and written English
Ability and willingness to upload data either via WiFi or mobile data
Living at fixed address
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other illness or co-morbidity that may limit participation to the program
Persons deemed not suitable by multidisciplinary treating team
Recruitment guidelines (due diligence to give consent)

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)
Allocation is not concealed
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
Single group
Other design features
Feasibility study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be carried out by CSIRO researchers on data server logs, service delivery related data and de-identified patient data. Use of the Health-e Minds system will be determined by examining the frequency and quantity of data uploads to the portal from participants’ smartphones and logins by healthcare practitioners to the web portal. User perceptions of the system will be assessed by evaluating responses to survey questionnaires. These results will be reported in a descriptive form.
Secondary analyses will include participants data measured at baseline, 6-weeks and 12-weeks. Clinical characteristics at baseline will be described using means ± standard deviations (SD) for continuous symmetrical variables and as medians and interquartile ranges (IQR) for skewed data. Categorical variables will be presented as counts and percentages. Differences within the group from baseline to 6-weeks and 12-weeks will be examined using the paired t-test for symmetrical data and the Wilcoxon signed-rank test for skewed data.
Linear mixed model regression will be used to compare longitudinal changes across baseline, 6-weeks and 12-weeks. All statistical tests will be two-tailed and a p-value of 0.05 or less used to indicate statistical significance. All statistical analyses will be performed using statistical software Stata Release 12 (TX: StataCorp LP).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
28/06/2019
Actual
Date of last data collection
Anticipated
30/09/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13373 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 25976 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 302235 0
Charities/Societies/Foundations
Name [1] 302235 0
Sunshine Coast PHN: Partners in Recovery
Country [1] 302235 0
Australia
Funding source category [2] 302240 0
Government body
Name [2] 302240 0
CSIRO
Country [2] 302240 0
Australia
Primary sponsor type
Hospital
Name
Nambour General Hospital
Address
Hospital Road,
Nambour
Queensland
4560
Country
Australia
Secondary sponsor category [1] 302176 0
None
Name [1] 302176 0
Address [1] 302176 0
Country [1] 302176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302913 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 302913 0
Ethics committee country [1] 302913 0
Australia
Date submitted for ethics approval [1] 302913 0
26/11/2018
Approval date [1] 302913 0
05/02/2019
Ethics approval number [1] 302913 0
Ethics committee name [2] 302978 0
CSIRO HREC
Ethics committee address [2] 302978 0
Ethics committee country [2] 302978 0
Australia
Date submitted for ethics approval [2] 302978 0
29/03/2019
Approval date [2] 302978 0
Ethics approval number [2] 302978 0

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

Contacts
Principal investigator
Name 91826 0
Dr Stuart Polkinghorne
Address 91826 0
Nambour General Hospital
Hospital Rd, Nambour
Queensland
4560
Country 91826 0
Australia
Phone 91826 0
+61 7 5470 6600
Fax 91826 0
Email 91826 0
stuart.polkinghorne@health.qld.gov.au
Contact person for public queries
Name 91827 0
Marlien Varnfield
Address 91827 0
Level 5, UQ Health Sciences Building
Royal Brisbane and Women's Hospital
Cnr Butterfield Street and Bowen Bridge Road,
Herston, Queensland
4029
Country 91827 0
Australia
Phone 91827 0
+61 732533603
Fax 91827 0
Email 91827 0
marlien.varnfield@csiro.au
Contact person for scientific queries
Name 91828 0
Marlien Varnfield
Address 91828 0
Level 5, UQ Health Sciences Building
Royal Brisbane and Women's Hospital
Cnr Butterfield Street and Bowen Bridge Road,
Herston, Queensland
4029
Country 91828 0
Australia
Phone 91828 0
+61 732533603
Fax 91828 0
Email 91828 0
marlien.varnfield@csiro.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Analyses by CSIRO researcher will be carried out on health services information and clinical outcomes on de-identified patient data only. All results will be reported collectively. Individuals will not be identifiable in any publication arising from the research.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Severe mental illness affects one in five Australi... [More Details]

Documents added automatically
No additional documents have been identified.