ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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

ACTRN12618001364268

Ethics application status

Approved

Date submitted

10/08/2018

Date registered

14/08/2018

Date last updated

5/04/2022

Date data sharing statement initially provided

7/08/2019

Date results provided

5/04/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Monitoring of injury and psychosocial health outcomes, career trajectories and continuing education, lived experiences and social connectedness: A pilot longitudinal cohort study of Macquarie University graduates (MQ-MINDS)

Scientific title

Macquarie MINDS: Monitoring of Injury and psychosocial health outcomes, career trajectories and continuing educatioN, LiveD experiences and Social connectedness

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

MQ-MINDS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Health-related quality of life

Wellbeing

Mental health

Social connectedness

Injury

Health service use

Physical inactivity

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Mental Health

Studies of normal psychology, cognitive function and behaviour

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Participants will be asked to complete an online survey that measures a wide range of health and lifestyle factors. The online survey, which takes approximately 30 minutes to complete, will be administered at baseline and at 12 months post-baseline. The online survey includes questions about: general physical and mental health, employment and work satisfaction, social media use, major life events and social readjustment, resilience, physical activity and sedentary behaviour, injury, and risk behaviour (e.g. smoking, alcohol, and drug use).

Survey responses will be linked to personal health information from administrative data collections (ie, ambulance dispatches, emergency department presentations, hospital admissions, cancer registry, and mortality records) in New South Wales (NSW) from 1 April 2018 to 12 months after the completion of the baseline survey. Participants will have an opportunity to opt out of having their survey responses linked to their health records during the web-based registration process. The secure health data linkage will be conducted by the NSW Centre for Health Record Linkage (CHeReL). For ththe purpose of this study we will not seek to collect any linked health records, only to obtain fact of linkage from CHeReL.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in general physical and mental health status as assessed using SF-12

Timepoint [1]

Baseline, 12 months post-baseline (primary timepoint)

Primary outcome [2]

Change in general anxiety as assessed using the Generalized Anxiety Disorder Scale (GAD-7)

Timepoint [2]

Baseline, 12 months post-baseline (primary timepoint)

Primary outcome [3]

Change in social support as assessed by the Multidimensional Scale of Perceived Social Support (MSPSS)

Timepoint [3]

Baseline, 12 months post-baseline (primary timepoint)

Secondary outcome [1]

Change in anxiety as assessed using the Kessler Psychological Distress Scale (K10)

Timepoint [1]

Baseline, 12 months post-baseline

Secondary outcome [2]

Change in social anxiety as assessed using the Short Form Social Interaction Anxiety Scale (SIAS-6)

Timepoint [2]

Baseline, 12 months post-baseline

Secondary outcome [3]

Change in resilience as assessed using the Brief Resilience Coping Scale

Timepoint [3]

Baseline, 12 months post-baseline

Eligibility

Key inclusion criteria

Macquarie University students (undergraduate and postgraduate) graduating in 2018

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

None

Study design

Purpose

Psychosocial

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

28/05/2018

Date of last participant enrolment

Anticipated

31/10/2018

Actual

11/11/2018

Date of last data collection

Anticipated

31/10/2019

Actual

15/12/2020

Sample size

Target

200

Accrual to date

Final

238

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University

Address [1]

Research Office Building C5C, Research Hub East, Level 3 Macquarie University NSW 2019

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Reidar P. Lystad

Address

Australian Institute of Health Innovation
Level 6, 75 Talavera Road
Macquarie University NSW 2109

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

A/Prof Rebecca Mitchell

Address [1]

Australian Institute of Health Innovation Faculty of Medicine and Health Sciences Macquarie University NSW 2109

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee (Medical Sciences)

Ethics committee address [1]

Research Services
Research Hub, Building C5C East
Macquarie University NSW 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/03/2018

Approval date [1]

02/05/2018

Ethics approval number [1]

5201600265

Ethics committee name [2]

NSW Population & Health Services Research Ethics Committee

Ethics committee address [2]

Cancer Institute NSW
Level 9, 8 Central Avenue, Australian Technology Park, Eveleigh NSW 2015
PO Box 41, Alexandria NSW 1435

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

31/10/2020

Approval date [2]

14/10/2020

Ethics approval number [2]

2020/ETH01748

Summary

Brief summary

Throughout young people’s lives there are many different events and factors that can have an impact on their life course.  Changing health states, different lived experiences, exposure to diverse opportunities, education, and influences from cultural and socioeconomic circumstances can all have pivotal roles.  The MQ-MINDS Pilot Cohort Study aims to pilot the establishment of a large, longitudinal cohort study with a young adult demographic and routinely capturing information on life experiences and exposures and their impact on health-related quality of life, lifestyle, health, continuing education and career trajectories, which will be instrumental in understanding the determinants of healthy, resilient individuals over a unique segment of their life course.

Trial website

https://www.mq.edu.au/research/research-centres-groups-and-facilities/healthy-people/centres/australian-institute-of-health-innovation/aihi-research-centres/healthcare-resilience-and-implementation-science/mq-minds-cohort-study

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Reidar P. Lystad

Address

Australian Institute of Health Innovation Faculty of Medicine and Health Sciences Level 6, 75 Talavera Road Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 2464

Fax

[email protected]

Contact person for public queries

Name

Reidar P. Lystad

Address

Australian Institute of Health Innovation Faculty of Medicine and Health Sciences Level 6, 75 Talavera Road Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 2464

Fax

[email protected]

Contact person for scientific queries

Name

Reidar P. Lystad

Address

Australian Institute of Health Innovation Faculty of Medicine and Health Sciences Level 6, 75 Talavera Road Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 2464

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers at Macquarie University, students supervised by staff at Macquarie University, and members of the MQ-MINDS Steering Committee can apply to conduct research projects or sub-studies using data from the MQ-MINDS Cohort Study, provided the requirements of this policy are met.

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified baseline and follow-up survey data.

What types of analyses could be done with individual participant data?

• Analyses that do not have the potential to limit or prevent the conduct of other projects that would involve the same participant group (i.e. analyses not previously conducted or analyses no already planned).

When can requests for individual participant data be made (start and end dates)?

From:
Data will be available after the completion of the 12-month follow-up data collection.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• The process of obtaining access to data is outlined in the MQ-MINDS Data Access Policy.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3775	Other				Data Access Policy	Study-related document.pdf
3782	Other				Data Access Application Form	Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Monitoring health and well-being in emerging adults: Protocol for a pilot longitudinal cohort study.	2020	https://dx.doi.org/10.2196/16108
Dimensions AI	Feasibility of Monitoring Health and Well-being in Emerging Adults: Pilot Longitudinal Cohort Study	2022	https://doi.org/10.2196/30027

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically