Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001304628
Ethics application status
Approved
Date submitted
7/11/2014
Date registered
15/12/2014
Date last updated
10/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Monitoring biopsychosocial (BPS) health and wellbeing indices through wearable sensor devices and affective (emotions and mood) mobile app: The development of predictive algorithms to better understand and improve health.
Scientific title
Monitoring biopsychosocial (BPS) health and wellbeing indices through wearable sensor devices and affective (emotions and mood) mobile app: The development of predictive algorithms to better understand and improve health in adults.
Secondary ID [1] 285606 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Determining algorithms/profiles between affective states and physiological markers (such as heart rate variability, sleep quality, activity levels, social interaction) 293453 0
Condition category
Condition code
Mental Health 293734 293734 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants (members of the general community) in this BPS monitoring study will be asked to complete pre-monitoring questionnaires and to wear a biometric sensor device which will be provided to them. Participants will be asked to wear the sensor device for 24 hours or up to four weeks. The sensor devices collect information such as heart rate, the number of steps taken, skin temperature, etc. While wearing the device, the participant will also be asked to respond to five mobile phone alerts per day, asking them to input how they are currently feeling and what they are doing. The biometric data and the affective (psychosocial) mobile application data will be merged and analysed.

Participants will be able to nominate their preference as to which device they would like to use, however this will be dependent upon availability of devices.

The app/biometric devices being used include:


Affective (Psychosocial) Mobile App
The affective mobile app is programmed so that during any given day, five randomly timed alerts, are sent to the participant asking questions about current affect, management strategies and general health and wellness questions.

BASIS watch: The BASIS watch is a wrist watch that continuously measures heart rate, skin perspiration, skin temperature, number of steps taken and sleep metrics (onset, interruptions, and wake times). Apart from wearing and recharging the watch (typically for 30 minutes every 4 days), the participant does not need to do anything else. Participants who receive the BASIS watch are asked to wear it for two to four weeks (except when showering).

The Equivital system involves wearing a chest belt harness, as well as a galvanic skin response velcro sensor on one’s finger tip, to continuously monitor heart rate, heart rate variability, respiration rate, body position, skin temperature and galvanic skin response for 24 hours (except when showering or engaging in activity that might damage or dirty the device).

The eMotion devices (eMotion HRV and Faros 360) records and logs heart rate variability and movement data. These devices are small and the eMotion HRV does not require a chest belt; rather it contains two sensors that sit firmly on the chest. Participants will be asked to wear these devices for one 24 hour interval (except when showering).

Intervention code [1] 290559 0
Not applicable
Comparator / control treatment
No control condition is being used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293533 0
Affective mood states as measured by the Affective mobile app in real time.
Timepoint [1] 293533 0
Measured five times a day (random alerts) by the Affective mobile app. The completion of the survey will take between 1-3 minutes and the number of days whereby participants will be asked to complete the daily affective app survey's range from 1 day to 4 weeks.
Secondary outcome [1] 311275 0
Psychological self report measures (PHQ-9, GAD-7, Kessler 6, Difficulties in Emotional Regulation Scale, Emotional Regulation Scale, Mindfulness Awareness, Perceived Stress Scale, Personality Traits, Mental Health Continuum and the Flourishing Scale) will be recorded for possible sub-group analysis, classification and predictors of biometric data patterns.
Timepoint [1] 311275 0
The psychological self report measures will be administered once, prior to the using the affective mobile app and wearing the biometric devices.
Secondary outcome [2] 311752 0
Biometric data (heart rate, heart rate variability, respiration rate, skin temperature, movement, galvanic skin response) as measured by the biometric devices.
Timepoint [2] 311752 0
Continuously for a period of 24 hours and up to 4 weeks.

Eligibility
Key inclusion criteria
Adults with access to the internet, an internet-connected mobile phone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to attend appointments with research staff at Federation University, pregnant, having a documented life threatening illness (e.g., cancer), traumatic brain injury, cardiovascular disease, or a current untreated severe (psychotic) mental illness.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data mining techniques and multivariate methods, such as pattern classification analysis, cluster analysis, orthogonal vector models and scaling methodology will be used to identify clustering biopsychosocial variables and derive predictive algorithms. Time series forecasting techniques using hidden markov models and weighted sum inference will also be deployed.

Two hundred participants are required to be sufficiently powered to undertake the data mining activities.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
22/12/2014
Actual
Date of last participant enrolment
Anticipated
30/05/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290198 0
University
Name [1] 290198 0
Federation University, Collaborative Research Network.
Country [1] 290198 0
Australia
Primary sponsor type
University
Name
Federation Universtiy
Address
Federation University, University Drive, Mt Helen Campus, 3350, Victoria
Country
Australia
Secondary sponsor category [1] 288909 0
None
Name [1] 288909 0
Address [1] 288909 0
Country [1] 288909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291909 0
Federation University Ethics Committee
Ethics committee address [1] 291909 0
Ethics committee country [1] 291909 0
Australia
Date submitted for ethics approval [1] 291909 0
Approval date [1] 291909 0
25/06/2014
Ethics approval number [1] 291909 0
A14-086

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

Contacts
Principal investigator
Name 52558 0
Prof Britt Klein
Address 52558 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 52558 0
Australia
Phone 52558 0
61 03 5327 6717
Fax 52558 0
Email 52558 0
[email protected]
Contact person for public queries
Name 52559 0
Britt Klein
Address 52559 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 52559 0
Australia
Phone 52559 0
61 03 5327 6717
Fax 52559 0
Email 52559 0
[email protected]
Contact person for scientific queries
Name 52560 0
Britt Klein
Address 52560 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 52560 0
Australia
Phone 52560 0
61 03 5327 6717
Fax 52560 0
Email 52560 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.