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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06487130




Registration number
NCT06487130
Ethics application status
Date submitted
14/08/2023
Date registered
5/07/2024

Titles & IDs
Public title
Virtual perI-/Menopause Registry of AusTrALia
Scientific title
Virtual perI-/Menopause Registry of AusTrALia
Secondary ID [1] 0 0
VITAL-Oz
Universal Trial Number (UTN)
Trial acronym
VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 0 0
Perimenopausal Disorder 0 0
Postmenopausal Symptoms 0 0
Health Knowledge, Attitudes, Practice 0 0
Healthy Aging 0 0
Health Care Utilization 0 0
Health Care Seeking Behavior 0 0
Mental Health Impairment 0 0
Mental Deterioration 0 0
Mental Health Issue 0 0
Osteoporosis, Postmenopausal 0 0
Diabetes Mellitus Risk 0 0
Diabetes Mellitus, Type 2 0 0
Dementia 0 0
Cardiovascular Diseases 0 0
Menopause Related Conditions 0 0
Hot Flashes 0 0
Hot Flushes Aggravated 0 0
Economic Burden 0 0
Social Stigma 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause
Metabolic and Endocrine 0 0 0 0
Diabetes
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - N/A Observational Registry

Menopause/Post-menopause - Menopause/Post-menopause, born with ovaries

Peri-menopause - Peri-menopause, born with ovaries

Pre-menopause - Pre-menopause, born with ovaries

Other - Not born with ovaries


Other interventions: N/A Observational Registry
Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Australian peri-/menopause experience as measured by qualitative self-report generated via participation & feedback of a critical mass of at least 10,000 registry participants, broadly representative of the Australian population.
Timepoint [1] 0 0
Through input completion per participant, an average of 4 years
Secondary outcome [1] 0 0
Registry feasibility as measured by numbers of registry entries.
Timepoint [1] 0 0
Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.

Eligibility
Key inclusion criteria
* Any Australian over 18 years of age.
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
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2073
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bespoke Clinical Research
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Erin B Morton, PhD,Medicine
Address 0 0
Bespoke Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Erin B Morton, PhD,Medicine
Address 0 0
Country 0 0
Phone 0 0
+61403157844
Fax 0 0
Email 0 0
vital@bespokeclinicalresearch.com.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual Participant Data collected during the trial may be shared but only if that individual participant specifically consented to it, \& only after approval decisions from both Ethics Committee \& VITAL Steering Committee review. Otherwise any sharing and/or publication of this data will be deidentified and/or aggregated as appropriate.
When will data be available (start and end dates)?
Start dates: As appropriate to minimum data level reached for the question of interest.

End dates: At end of registry unless particular parameters are removed via amendment during annual conduct, whereupon 15 years after final collection.
Available to whom?
Detailed requests must be submitted with ethics approval to the VITAL Steering Committee for review consideration. Sharing will be on hold by default until otherwise specified in VITAL information including public-facing webpage. Only IPD with individual-level consent will be shared. Otherwise any sharing and/or publication of VITAL data will be deidentified and/or aggregated as appropriate. Upon reaching internally-defined minimum data levels, more information on the IPD sharing request processes will be made available on the VITAL website.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://bespokeclinicalresearch.com.au/vitalimpact/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06487130