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Trial registered on ANZCTR


Registration number
ACTRN12617001425381
Ethics application status
Approved
Date submitted
5/10/2017
Date registered
9/10/2017
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
MonitorMe: An open trial of an interactive biopsychosocial self-monitoring digital health program with decision support, timely strategy information and tools.
Scientific title
An open evaluation trial of the MonitorMe digital health self-monitoring program, offered through My Digital Health, for reducing stress, anxiety and depressive symptoms and increasing mental wellbeing in adults.
Secondary ID [1] 293053 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety symptoms 304971 0
Depressive symptoms 304972 0
Stress symptoms 304973 0
Mental Wellbeing 304975 0
Condition category
Condition code
Mental Health 304301 304301 0 0
Anxiety
Mental Health 304302 304302 0 0
Depression
Mental Health 304336 304336 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A self-monitoring digital health program (MonitorMe), offered through the My Digital Health platform for adults in the general community, will be evaluated using a quasi-experimental trial design. People taking part in the study will receive immediate access to the MonitorMe program following completion of the pre-program survey.

MonitorMe is self-help digital health program designed to enable people to self-monitor their mood and daily lifestyle events with minimal effort, and provide them with decision supports to help them interpret their self-monitoring scores and stayed engaged. These decision support tools also provide the person with relevant feedback and timely ‘life skills’ strategy information and practice tools that either work at maintaining their current healthy behaviours or assist them to get back on track when things are not going so well (depending on what their actual scores indicate). The skill strategy information covers biological, psychological, social, and wellness domains, all designed to increase mind and body health (e.g., brain & gut nutrition, emotional regulation strategies, sleep hygiene, social connectedness, practising gratitude) and take approximately 5-20 minutes to work through. Background information is also provided on health and wellbeing (e.g., the stress response, brain/neural plasticity).

Participants will be asked to complete the self-monitoring survey each day taking approximately 1 minute. Then, once every week, participants will be asked to use the ‘Monitoring Graph’ decision support tool that will walk them through their self-monitoring scores from the past 7 days. Using the decision support tool will require 2 to 20 minutes per week (depending on their individual scores). Participants will also receive automated emails (e.g., daily self-monitoring survey reminders, alerts if their scores indicate a decline, when to complete program assessment surveys). The MonitorMe program includes text, graphics, audio, video, quizzes, an interactive self-monitoring tool, interactive games and downloads. MonitorMe can be accessible via web, mobile or tablet devices.

The MonitorMe program is housed within the participant's ‘My Digital Health’ dashboard. My Digital Health is the parent platform that houses a variety of digital health programs. Via the participant’s dashboard, they are able to access several resources. This includes: My Dashboard, My Inbox, My Daily Monitoring, My Progress Graphs, My Timeline, My Profile and My Tutorial. It also includes a ‘Connect to Practitioner’ request button. If clicked, an Australian-based participant can request that we add their healthcare practitioner to their My Digital Health account. If the healthcare practitioner consents to participate, the healthcare practitioner is then digitally connected to the participant’s My Digital Health account.

Participants will be asked to complete a pre-program survey assessment (Week 0), followed by 5 additional ‘during’ assessments (one every 4 weeks), and a post-program (Week 25) and 6-month follow-up (Week 49) assessment survey. Participants will also be asked questions relating to their program engagement levels at post-program assessment. Although the evaluation trial runs for 49 weeks, participants will be able to have continued access to MonitorMe digital health program after that time. At any stage, participants can ‘opt out’ of the study / or the program, by clicking a button in their ‘My Profile’ section.

Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / strategies they visited / used and when), as well as reviewing the completion of daily mood and lifestyle event survey data and the scheduled intervention assessments. Participating healthcare practitioners may be invited to provide feedback about their digital connection experience.
Intervention code [1] 299290 0
Prevention
Intervention code [2] 299291 0
Behaviour
Intervention code [3] 299292 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303566 0
Stress symptoms will be measured by the DASS (Stress subscale)
Timepoint [1] 303566 0
Pre intervention (Week 0), during intervention (Week 5, 9, 13, 17, 21), post intervention (Week 25) and 6 month follow up (Week 49).
Primary outcome [2] 303567 0
Anxiety symptoms will be measured by using the GAD7
Timepoint [2] 303567 0
Pre intervention (Week 0), during intervention (Week 5, 9, 13, 17, 21), post intervention (Week 25) and 6 month follow up (Week 49).
Primary outcome [3] 303568 0
Depressive symptoms will be measured by using the PHQ9
Timepoint [3] 303568 0
Pre intervention (Week 0), during intervention (Week 5, 9, 13, 17, 21), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [1] 339397 0
Mental health wellbeing will be measured by using the MCH-SF
Timepoint [1] 339397 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [2] 339398 0
Insomnia symptoms using the ISI
Timepoint [2] 339398 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [3] 339399 0
Emotional regulation using the DERS - B
Timepoint [3] 339399 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [4] 339400 0
Optimism using the LOT-R
Timepoint [4] 339400 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [5] 339401 0
Quality of life using the EQ-5D
Timepoint [5] 339401 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [6] 339402 0
Psychological distress as measured by the K10
Timepoint [6] 339402 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [7] 339403 0
Social Connectedness using the SCAS
Timepoint [7] 339403 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [8] 339404 0
Personality traits using the TIPI
Timepoint [8] 339404 0
Pre intervention (Week 0)
Secondary outcome [9] 339405 0
Intervention satisfaction, including engagement, will be measured using the TSQ
Timepoint [9] 339405 0
Post Intervention (Week 25)
Secondary outcome [10] 339406 0
Alcohol and drug use levels (self-developed questions) and followed up with CAGE-AID questions if problematic use is indicated
Timepoint [10] 339406 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [11] 339407 0
Chronic physical illness diagnosis questions (self developed)
Timepoint [11] 339407 0
Pre intervention (Week 0)
Secondary outcome [12] 339408 0
Mental health condition diagnosis questions (self developed)
Timepoint [12] 339408 0
Pre intervention (Week 0)
Secondary outcome [13] 339409 0
Current use of prescribed medication(s) question and followed up with medication type (self-developed) and the MARS, if medication is being taken.
Timepoint [13] 339409 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [14] 339410 0
Caffeine use and dependence questions (self-developed)
Timepoint [14] 339410 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [15] 339411 0
Physical activity levels using single item questions (self developed)
Timepoint [15] 339411 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [16] 339412 0
Use of services for a physical and mental health conditions questions (self developed)
Timepoint [16] 339412 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [17] 339413 0
Mental health, physical health and quality of life question - 6 point rating scale (self developed)
Timepoint [17] 339413 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).
Secondary outcome [18] 339414 0
Anxiety subtype questions (self developed)
Timepoint [18] 339414 0
Pre intervention (Week 0), post intervention (Week 25) and 6 month follow up (Week 49).

Eligibility
Key inclusion criteria
Must be 18 years of age or older.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No internet access, does not create a My Digital Health account (requires the provision of a valid email address), does not provide consent to study conditions.

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Pre-, post- and follow-up variables will be subjected to mixed methods repeated measures to determine significant changes over time.

Previous research has reported medium effects can be expected. Therefore, assuming a conservative small - medium effect (i.e. GPower f(v) test = 0.25), significance set at 5% (p = .05), power at 80%, a sample of 38 will be required to demonstrate statistical significance on the primary outcome measure. However, allowing for a 50% attrition rate, we will be required to recruit 76 participants.

Recruitment
Recruitment status
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 9261 0
New Zealand
State/province [1] 9261 0
Country [2] 9262 0
Canada
State/province [2] 9262 0
Country [3] 9263 0
United Kingdom
State/province [3] 9263 0
Country [4] 9264 0
United States of America
State/province [4] 9264 0

Funding & Sponsors
Funding source category [1] 297677 0
University
Name [1] 297677 0
Federation University
Address [1] 297677 0
University Drive, Mt Helen Campus, Victoria, 3350
Country [1] 297677 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 296696 0
None
Name [1] 296696 0
Address [1] 296696 0
Country [1] 296696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298749 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 298749 0
Federation University.
Office 218, Building F, Mt Helen Campus.
PO Box 663, Ballarat,
Victoria, 3353
Ethics committee country [1] 298749 0
Australia
Date submitted for ethics approval [1] 298749 0
10/07/2017
Approval date [1] 298749 0
26/07/2017
Ethics approval number [1] 298749 0
A17-107

Summary
Brief summary
A self-monitoring digital health program (MonitorMe), offered through the My Digital Health platform for adults in the general community, will be evaluated using a quasi-experimental trial design. People taking part in the study will receive immediate access to the MonitorMe program following completion of the pre-program survey.

MonitorMe is self-help digital health program designed to enable people to self-monitor their mood and daily lifestyle events with minimal effort, and provide them with decision supports to help them interpret their self-monitoring scores and stayed engaged. These decision support tools also provide the person with relevant feedback and timely ‘life skills’ strategy information and practice tools that either work at maintaining their current healthy behaviours or assist them to get back on track when things are not going so well (depending on what their actual scores indicate).

Participants will be asked to complete the self-monitoring survey that should take approximately 1 minute each day. Then once every week, participants will be asked to use the ‘Monitoring Graph’ decision support tool that walk them through their self-monitoring scores from the past 7 days. Using the decision support tool will require 2 to 20 minutes per week (depending on their individual scores). In addition, participants will be asked to complete a pre-program survey assessment (Week 0), followed by 5 additional ‘during’ assessments (one every 4 weeks), and a post-program (Week 25) and 6-month follow-up (Week 49) survey assessment.

It is expected that people who undertake MonitorMe program will show reductions in their stress, anxiety and depressive symptoms at post-intervention and follow-up assessment time points, as well as increases in mental wellbeing.
Trial website
https://monitor.mydigitalhealth.org.au (direct, child site)
https://www.mydigitalhealth.org.au (parent site)
Trial related presentations / publications
Public notes
MonitorMe is globally accessible via the web.

Contacts
Principal investigator
Name 78106 0
Prof Britt Klein
Address 78106 0
Federation University.
University Drive, Mt Helen Campus, Victoria, 3350
Country 78106 0
Australia
Phone 78106 0
+61 3 5327 6717
Fax 78106 0
Email 78106 0
b.klein@federation.edu.au
Contact person for public queries
Name 78107 0
Prof Britt Klein
Address 78107 0
Federation University.
University Drive, Mt Helen Campus, Victoria, 3350
Country 78107 0
Australia
Phone 78107 0
+61 3 5327 6717
Fax 78107 0
Email 78107 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 78108 0
Prof Britt Klein
Address 78108 0
Federation University.
University Drive, Mt Helen Campus, Victoria, 3350
Country 78108 0
Australia
Phone 78108 0
+61 3 5327 6717
Fax 78108 0
Email 78108 0
b.klein@federation.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?
Relevant individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
No start or end date as yet determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
Case-by-case basis at the discretion of Principal Investigator.
How or where can data be obtained?
Access subject to approval by Principal Investigator, followed by submission to the Ethical Review Committee to access the de-identified data and approval granted.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1095 0
Informed consent form
Citation [1] 1095 0
Link [1] 1095 0
Email [1] 1095 0
Other [1] 1095 0
https://monitor.mydigitalhealth.org.au/plain-language-information-statement/ (participant version)
https://monitor.mydigitalhealth.org.au/plis_hcp/ (healthcare practitioner version)
Attachment [1] 1095 0
Summary results
No Results