Trial Review

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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] 295777 0
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 309184 0
Wellbeing 309186 0
Mental health 309188 0
Social connectedness 309189 0
Injury 309190 0
Health service use 309191 0
Physical inactivity 309219 0
Condition category
Condition code
Injuries and Accidents 308060 308060 0 0
Other injuries and accidents
Mental Health 308061 308061 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 308062 308062 0 0
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] 312107 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307062 0
Change in general physical and mental health status as assessed using SF-12
Timepoint [1] 307062 0
Baseline, 12 months post-baseline (primary timepoint)
Primary outcome [2] 307063 0
Change in general anxiety as assessed using the Generalized Anxiety Disorder Scale (GAD-7)
Timepoint [2] 307063 0
Baseline, 12 months post-baseline (primary timepoint)
Primary outcome [3] 307064 0
Change in social support as assessed by the Multidimensional Scale of Perceived Social Support (MSPSS)
Timepoint [3] 307064 0
Baseline, 12 months post-baseline (primary timepoint)
Secondary outcome [1] 350513 0
Change in anxiety as assessed using the Kessler Psychological Distress Scale (K10)
Timepoint [1] 350513 0
Baseline, 12 months post-baseline
Secondary outcome [2] 350514 0
Change in social anxiety as assessed using the Short Form Social Interaction Anxiety Scale (SIAS-6)
Timepoint [2] 350514 0
Baseline, 12 months post-baseline
Secondary outcome [3] 350562 0
Change in resilience as assessed using the Brief Resilience Coping Scale
Timepoint [3] 350562 0
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] 300368 0
University
Name [1] 300368 0
Macquarie University
Country [1] 300368 0
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] 299821 0
Individual
Name [1] 299821 0
A/Prof Rebecca Mitchell
Address [1] 299821 0
Australian Institute of Health Innovation
Faculty of Medicine and Health Sciences
Macquarie University NSW 2109
Country [1] 299821 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301180 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 301180 0
Ethics committee country [1] 301180 0
Australia
Date submitted for ethics approval [1] 301180 0
07/03/2018
Approval date [1] 301180 0
02/05/2018
Ethics approval number [1] 301180 0
5201600265
Ethics committee name [2] 310701 0
NSW Population & Health Services Research Ethics Committee
Ethics committee address [2] 310701 0
Ethics committee country [2] 310701 0
Australia
Date submitted for ethics approval [2] 310701 0
31/10/2020
Approval date [2] 310701 0
14/10/2020
Ethics approval number [2] 310701 0
2020/ETH01748

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

Contacts
Principal investigator
Name 86122 0
Dr Reidar P. Lystad
Address 86122 0
Australian Institute of Health Innovation
Faculty of Medicine and Health Sciences
Level 6, 75 Talavera Road
Macquarie University NSW 2109
Country 86122 0
Australia
Phone 86122 0
+61 2 9850 2464
Fax 86122 0
Email 86122 0
[email protected]
Contact person for public queries
Name 86123 0
Reidar P. Lystad
Address 86123 0
Australian Institute of Health Innovation
Faculty of Medicine and Health Sciences
Level 6, 75 Talavera Road
Macquarie University NSW 2109
Country 86123 0
Australia
Phone 86123 0
+61 2 9850 2464
Fax 86123 0
Email 86123 0
[email protected]
Contact person for scientific queries
Name 86124 0
Reidar P. Lystad
Address 86124 0
Australian Institute of Health Innovation
Faculty of Medicine and Health Sciences
Level 6, 75 Talavera Road
Macquarie University NSW 2109
Country 86124 0
Australia
Phone 86124 0
+61 2 9850 2464
Fax 86124 0
Email 86124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified baseline and follow-up survey data.
When will data be available (start and end dates)?
Data will be available after the completion of the 12-month follow-up data collection.
Available to whom?
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.
Available for what types of analyses?
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).
How or where can data be obtained?
The process of obtaining access to data is outlined in the MQ-MINDS Data Access Policy.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMonitoring health and well-being in emerging adults: Protocol for a pilot longitudinal cohort study.2020https://dx.doi.org/10.2196/16108
Dimensions AIFeasibility of Monitoring Health and Well-being in Emerging Adults: Pilot Longitudinal Cohort Study2022https://doi.org/10.2196/30027
N.B. These documents automatically identified may not have been verified by the study sponsor.