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Trial registered on ANZCTR


Registration number
ACTRN12617001427369
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 self-monitoring digital health program with decision support, timely strategy information and tools for clients of a regional community health service.
Scientific title
An open evaluation trial of the MonitorMe digital health self-monitoring program, for reducing stress, anxiety and depressive symptoms and increasing mental wellbeing in adult clients from a large regional community health service provider.
Secondary ID [1] 293054 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress symptoms 304976 0
Anxiety symptoms 304977 0
Depressive symptoms 304978 0
Mental wellbeing 304979 0
Condition category
Condition code
Mental Health 304304 304304 0 0
Anxiety
Mental Health 304305 304305 0 0
Depression
Mental Health 304337 304337 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A self-monitoring digital health program (MonitorMe), offered to adult clients from a large regional healthcare service provider, 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 tools 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.

Participants will be asked to complete a pre-program survey assessment (Week 0), followed by 2 ‘during’ assessments (Week 2 & 5), and a post-program (Week 9) and 1-month follow-up (Week 13) survey assessment. Participants will also be asked questions relating to their program engagement levels at post-program assessment.

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. Program access will continue for 4 weeks following the 1-month follow-up assessment.
Intervention code [1] 299293 0
Prevention
Intervention code [2] 299294 0
Behaviour
Intervention code [3] 299295 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303569 0
Stress symptoms will be measured by the DASS (Stress subscale)
Timepoint [1] 303569 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Primary outcome [2] 303570 0
Anxiety symptoms will be measured by using the GAD7
Timepoint [2] 303570 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Primary outcome [3] 303571 0
Depressive symptoms will be measured by using the PHQ9
Timepoint [3] 303571 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [1] 339415 0
Mental health wellbeing will be measured by using the MCH-SF
Timepoint [1] 339415 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [2] 339416 0
Emotional regulation using the DERS - B
Timepoint [2] 339416 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [3] 339417 0
Psychological distress as measured by the K10
Timepoint [3] 339417 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [4] 339418 0
Personality traits using the TIPI
Timepoint [4] 339418 0
Pre intervention (Week 0)
Secondary outcome [5] 339419 0
Intervention satisfaction, including engagement, will be measured using the TSQ
Timepoint [5] 339419 0
Post intervention (Week 9)
Secondary outcome [6] 339420 0
Alcohol and drug use levels (self-developed questions) and followed up with CAGE-AID questions if problematic use is indicated
Timepoint [6] 339420 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [7] 339421 0
Chronic physical illness and mental health diagnosis questions (self developed)
Timepoint [7] 339421 0
Pre intervention (Week 0)
Secondary outcome [8] 339422 0
Anxiety subtype questions (self developed)
Timepoint [8] 339422 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [9] 339423 0
Mental health, physical health and quality of life question - 6 point rating scale (self developed)
Timepoint [9] 339423 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [10] 339424 0
Use of services for a physical and mental health conditions questions (self developed)
Timepoint [10] 339424 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [11] 339425 0
Physical activity levels using single item questions (self developed)
Timepoint [11] 339425 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [12] 339427 0
Sleep quantity question (self-developed).
Timepoint [12] 339427 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [13] 339428 0
Current use of prescribed medication(s) question (self-developed)
Timepoint [13] 339428 0
Pre intervention (Week 0), during intervention (Week 5), post intervention (Week 9) and 1 month follow up (Week 13).
Secondary outcome [14] 365937 0
Program usability will be measured by the System Usability Scale
Timepoint [14] 365937 0
During intervention (Start of Week 2)

Eligibility
Key inclusion criteria
Must be 18 years of age or older and a client of the regional healthcare service provider.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No internet access, does not create an 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
Not yet recruiting
Date of first participant enrolment
Anticipated
22/01/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
11/04/2021
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297678 0
University
Name [1] 297678 0
Federation University
Country [1] 297678 0
Australia
Funding source category [2] 297680 0
Other
Name [2] 297680 0
Uniting Wimmera
Country [2] 297680 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 296697 0
None
Name [1] 296697 0
Address [1] 296697 0
Country [1] 296697 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298750 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 298750 0
Ethics committee country [1] 298750 0
Australia
Date submitted for ethics approval [1] 298750 0
25/08/2017
Approval date [1] 298750 0
07/09/2017
Ethics approval number [1] 298750 0
A17-130

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

Contacts
Principal investigator
Name 78110 0
Prof Britt Klein
Address 78110 0
Federation University.
University Drive, Mt Helen Campus, Victoria, 3350
Country 78110 0
Australia
Phone 78110 0
+61 3 5327 6717
Fax 78110 0
Email 78110 0
b.klein@federation.edu.au
Contact person for public queries
Name 78111 0
Britt Klein
Address 78111 0
Federation University.
University Drive, Mt Helen Campus, Victoria, 3350
Country 78111 0
Australia
Phone 78111 0
+61 3 5327 6717
Fax 78111 0
Email 78111 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 78112 0
Britt Klein
Address 78112 0
Federation University.
University Drive, Mt Helen Campus, Victoria, 3350
Country 78112 0
Australia
Phone 78112 0
+61 3 5327 6717
Fax 78112 0
Email 78112 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1096Informed consent form    https://monitorme-uw.mydigitalhealth.org.au/plain-... [More Details]



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.