Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000423415p
Ethics application status
Submitted, not yet approved
Date submitted
8/04/2025
Date registered
8/05/2025
Date last updated
8/05/2025
Date data sharing statement initially provided
8/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does offering a combination of video health and face-to-face visits for antenatal care result in improved patient experience and is it as safe as standard (face-to-face) care? A co-designed non-inferiority randomised controlled trial.
Scientific title
Does offering a combination of video health and face-to-face visits for antenatal care result in improved patient experience and is it as safe as standard (face-to-face) care? A co-designed non-inferiority randomised controlled trial.
Secondary ID [1] 313151 0
NHMRC Application ID: 2032615
Universal Trial Number (UTN)
Trial acronym
TULIP
Linked study record
ACTRN12622000915752 is the feasibility study conducted prior to this RCT.

Health condition
Health condition(s) or problem(s) studied:
pregnancy 335423 0
antenatal care 335424 0
Condition category
Condition code
Reproductive Health and Childbirth 331983 331983 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will have two arms – the intervention: combined video-based telehealth and face-to-face pregnancy care; and the control: all face-to-face pregnancy care.

Women allocated to the intervention will have a combination of video-based telehealth and face-to-face visits (consumer led, a minimum of one up to a maximum of five telehealth visits and the remainder face-to-face), from 20 weeks gestation. The following is the expected schedule of visits for the intervention:

20-22 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. If telehealth: Midwife reviews and discusses patients’ morphology ultrasound, if occurs prior to this appointment, organises further ultrasounds if required, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests if occurred prior to this appointment and organises further testing/management if required. Midwife organises gestational diabetes testing and any other testing appropriate to risk factors/indication prior to next appointment. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes.
If midwife appointment face-to-face: Midwife reviews and discusses patients’ morphology ultrasound, if occurs prior to this appointment, organises further ultrasounds if required, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests if occurred prior to this appointment and organises further testing/management if required. Midwife organises gestational diabetes testing and any other testing appropriate to risk factors/indication prior to next appointment. Midwife measures blood pressure and acts upon any abnormal findings. Duration 20 minutes

26-28 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. If telehealth*: Midwife reviews and discusses patients’ morphology ultrasound if occurred post last appointment, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife records symphysis-pubis fundal height measurement that has been self-measured by the woman and acts upon if required. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes
If midwife appointment face-to-face: Midwife reviews and discusses patients’ morphology ultrasound if occurred post last appointment, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If the woman is a negative blood group, Anti-D is administered. Duration 20 minutes.

30-31 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. Midwife appointment telehealth: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife records symphysis-pubis fundal height measurement that has been self-measured by the woman and acts upon if required. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes.
Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes.

34 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. Midwife appointment telehealth*: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife records symphysis-pubis fundal height measurement that has been self-measured by the woman and acts upon if required. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes.
Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If the woman is a negative blood group, Anti-D is administered. Duration 20 minutes.

36 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If woman consents, midwife organises Group B Streptococcus testing. Duration 20 minutes.

38 weeks gestation: Either midwife appointment telehealth OR midwife appointment face-to-face. Midwife appointment telehealth: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife records symphysis-pubis fundal height measurement that has been self-measured by the woman and acts upon if required. Midwife records recent blood pressure (taken at home prior to appointment) and acts upon if required. Duration 20 minutes.
Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes.

40 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes.

41 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Midwife organises follow up for induction of labour planning as per hospital guidelines. Duration 20 minutes.

*Where the woman is a negative blood group, this appointment will be made face-to-face to accommodate anti-D administration.

The visits at 36, 40, and 41 weeks gestation will be face-to-face. As telehealth visits will be conducted via video, routine physically examinations such as fundal height (measurement to monitor growth of the fetus), abdominal palpation for fetal position, auscultation of the fetal heart and blood pressure measurement will not be able to be undertaken during the appointment. Each woman randomised to combined care will be shown how to self-measure their symphysis pubis fundal height and will be provided with written instructions and a video to support them with this. Women will be asked to measure their sysmphysis pubis funal height prior to each telehealth appointment. Each woman randomised to combined care will be provided with a blood pressure machine, shown how to use it by the research midwife, provided with written instructions, and asked to take her blood pressure before each telehealth appointment.

Women will not need to decide their whole schedule in advance. The Government funded Health Direct portal, a free national encrypted web-based virtual public health service will be used for video-health calls. As it is a portal, women do not need to download an app, which is likely to increase ease of use and acceptability.
Intervention code [1] 329723 0
Prevention
Comparator / control treatment
Control: All face-to-face pregnancy care
20-22 weeks gestation: Midwife appointment face-to-face: Midwife reviews and discusses patients’ morphology ultrasound, if occurs prior to this appointment, organises further ultrasounds if required, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests if occurred prior to this appointment and organises further testing/management if required. Midwife organises gestational diabetes testing and any other testing appropriate to risk factors/indication prior to next appointment. Midwife measures blood pressure and acts upon any abnormal findings. Duration 20 minutes.

26-28 weeks gestation: Midwife appointment face-to-face: Midwife reviews and discusses patients’ morphology ultrasound if occurred post last appointment, assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If the woman is a negative blood group, Anti-D is administered. Duration 20 minutes.

30-31 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes.

34 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If the woman is a negative blood group, Anti-D is administered. Duration 20 minutes.

36 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. If woman consents, midwife organises Group B Streptococcus testing. Duration 20 minutes.

38 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes.

40 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews any recent tests/ultrasounds and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Duration 20 minutes.

41 weeks gestation: Midwife appointment face-to-face: Midwife assesses maternal and fetal health and concerns via discussion (e.g., fetal movement, presence/occurrence of pain/bleeding etc.), answers questions and provides education and screening appropriate to gestation, individual needs, and hospital guidelines. Midwife reviews recent tests/ultrasounds if occurred prior to this appointment and organises further testing/management if required. Midwife carries out symphysis-pubis fundal height measurement, abdominal palpation for fetal position, fetal heart rate auscultation and measures blood pressure and acts upon any abnormal findings. Midwife organises follow up for induction of labour planning as per hospital guidelines. Duration 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 340161 0
Composite outcome – proportion of participants who experience of any one (or more) of the adverse neonatal or maternal outcomes: • neonatal – preterm birth, small for gestational age at greater than or equal to 40 weeks, fetal growth restriction at greater than or equal to 40 weeks, macrosomia at greater than or equal to 4500g), term admission to Special Care Nursery/Neonatal Intensive Care, fetal death in utero, stillbirth, APGAR score less than 7 at five minutes post birth; • maternal– eclampsia, pre-eclampsia with severe features (e.g., HELLP syndrome), Intensive Care Unit/High Dependency Unit admission, death.
Timepoint [1] 340161 0
At three months post birth of last baby in study
Primary outcome [2] 340162 0
Primary consumer experience outcome - proportion of women rating overall care in pregnancy as '6' or '7' on a Likert-type scale where ‘1’ is ‘Very poor’ and ‘7’ is ‘Very good’.
Timepoint [2] 340162 0
This will be assessed at 4 months postpartum.
Secondary outcome [1] 443040 0
Anxiety symptoms
Timepoint [1] 443040 0
Measured at 36 weeks gestation and four months post birth
Secondary outcome [2] 443041 0
Depression symptoms
Timepoint [2] 443041 0
Measured at 36 weeks gestation and four months post birth
Secondary outcome [3] 443042 0
Disclosure of family violence in pregnancy via self report and then compared with medical record data.
Timepoint [3] 443042 0
36 weeks gestation. Compare with medical record data after birth.
Secondary outcome [4] 443043 0
Breastfeeding intention
Timepoint [4] 443043 0
Baseline at recruitment and at 36 weeks gestation.
Secondary outcome [5] 443046 0
Breastfeeding initiation
Timepoint [5] 443046 0
Data collected up to discharge from hospital care.
Secondary outcome [6] 443047 0
Maintenance of breastfeeding
Timepoint [6] 443047 0
Four months post birth.
Secondary outcome [7] 443048 0
Rate of attendance for routine pregnancy care
Timepoint [7] 443048 0
Post birth.
Secondary outcome [8] 443049 0
Baby born before arrival at hospital.
Timepoint [8] 443049 0
Post birth.
Secondary outcome [9] 443050 0
Mode of birth
Timepoint [9] 443050 0
Post birth.
Secondary outcome [10] 443051 0
Fear of childbirth
Timepoint [10] 443051 0
36 weeks gestation.
Secondary outcome [11] 443052 0
Stress symptoms
Timepoint [11] 443052 0
Measured at 36 weeks and at four months post birth.
Secondary outcome [12] 443053 0
Parenting self-efficacy and readiness
Timepoint [12] 443053 0
Measured at four months postpartum.
Secondary outcome [13] 443054 0
Quality of life
Timepoint [13] 443054 0
Assessed at 36 weeks gestation and four months post birth.
Secondary outcome [14] 443055 0
Economics - health service use since birth and cost effectiveness
Timepoint [14] 443055 0
Four months post birth
Secondary outcome [15] 443057 0
Smoking
Timepoint [15] 443057 0
Baseline at recruitment, at 36 weeks gestation and at four months post birth.
Secondary outcome [16] 447142 0
Vaping
Timepoint [16] 447142 0
Baseline at recruitment, at 36 weeks gestation and at four months post birth.
Secondary outcome [17] 447143 0
Alcohol consumption
Timepoint [17] 447143 0
Baseline at recruitment, at 36 weeks gestation and at four months post birth.
Secondary outcome [18] 447144 0
Body mass index (BMI)
Timepoint [18] 447144 0
Baseline at recruitment, at 36 weeks gestation and at four months post birth.

Eligibility
Key inclusion criteria
Women with a singleton pregnancy attending the study site as a public patient , assessed as low or moderate obstetric risk, aged 16 years or over, less than 24 weeks gestation and able to speak and understand English.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
At initial pregnancy booking visit women who are considered high risk needing close obstetric monitoring, maternal body mass index >40, drug and alcohol issues requiring specialist care, known major fetal anomaly or compromise requiring significant medical input (e.g. aneuploidy, heart defects), women unable to provide informed consent, women who do not have access to a computer, tablet or smart phone with a reliable internet connection for video-based telehealth appointments and women who choose shared care with an external provider.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A secure, password-protected, computerised randomisation schedule will be designed and administered by an independent service, accessed online by recruiting staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be randomly allocated to the intervention (Combined Care) or the control group (Usual Care), with stratification by a) parity (first baby or not), and b) obstetric risk status (low or moderate risk). The randomisation ratio will be 1:1 combined care to usual care, with permuted blocks of variable length
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: To estimate the baseline prevalence of women and infants with the composite outcome, we used data from 56,193 births from 2012 to 2019 (pre implementation of routine telehealth in pregnancy) from the Women’s, excluding women with multiple pregnancies, those with Type 1 and Type 2 diabetes and women with a BMI >40, and found 22% had the composite outcome (i.e., one or more of the factors in the list making up the composite). We believe that the risk of the composite outcome will be the same in the two groups, but the sample size calculations assumed that the true underlying proportion is 0.01 higher in the telehealth group (i.e., 0.22 vs 0.23) to be conservative. Based on clinically important differences, the non-inferiority margin was defined as an absolute increase in the composite outcome of 0.05 in the telehealth (‘intervention’) group. With a 2-sided 95% confidence interval, and 80% power, a sample size of 3426 (1713 per group) is required. We expect near complete ascertainment of the primary outcome based on our previous work43, 44 and given the outcome will be collected electronically, so allowing 2% loss to follow up we will need 3496 women in total, 1748 per group.
Planned analyses: Data will be collected to meet CONSORT guidelines. We will check the baseline comparability of the groups, then the intervention group will be compared with the control group for all trial hypotheses using intention-to-treat analysis. For the primary clinical outcome, the proportion of women (with their infants) having the composite outcome will be compared. Risk differences and 95% confidence intervals will be estimated using binomial regression with identity link, adjusting for all stratification variables, and for any differences in the key demographic characteristics at baseline. The adjusted risk difference and 95% confidence intervals will be presented graphically along with the non-inferiority margin.38 Combined care will be considered to be non-inferior if the upper limit of the 95% confidence interval for the risk difference (combined care minus usual care) is within the non-inferiority margin. For other outcomes standard superiority tests will be undertaken.38 Binary variables will be compared using relative risks with 95% confidence intervals, categorial variables compared using chi-squared, comparison of means will be undertaken using t-tests where data are normally distributed, or medians compared using Mann-Whitney U tests otherwise. The primary consumer experience outcome will be compared by dichotomising the 1-7 scale and comparing the percentage of women in each trial arm who rate their overall care in pregnancy as ‘6’ or ‘7’. For views and experiences of telehealth (applicable only to participants receiving telehealth), descriptive statistics will be used, with most items summarised using frequency and percentage, or analysed using standard superiority tests in any subgroup analyses. The incremental cost per quality adjusted life year gained for antenatal telehealth relative to standard care will be assessed. A one-year post-birth time horizon will be utilised, with a health service funder perspective taken. Costs will include all antenatal, birth and postnatal health service use in hospitals and the community, identified from hospital administrative data collected with consent from participating women.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
29/12/2028
Actual
Date of last data collection
Anticipated
1/10/2029
Actual
Sample size
Target
3496
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27430 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 43542 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 317594 0
Government body
Name [1] 317594 0
National Health and Medical Research Council
Country [1] 317594 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 319902 0
None
Name [1] 319902 0
Address [1] 319902 0
Country [1] 319902 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316299 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316299 0
Ethics committee country [1] 316299 0
Australia
Date submitted for ethics approval [1] 316299 0
27/11/2024
Approval date [1] 316299 0
Ethics approval number [1] 316299 0

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

Contacts
Principal investigator
Name 137442 0
Prof Della Forster
Address 137442 0
Judith Lumley Centre Level 3, George Singer Building Kingsbury Drive (no number) La Trobe University Bundoora 3086 Victoria
Country 137442 0
Australia
Phone 137442 0
+61 3 9479 8783
Fax 137442 0
Email 137442 0
[email protected]
Contact person for public queries
Name 137443 0
Charlie Benzie
Address 137443 0
Judith Lumley Centre Level 3, George Singer Building Kingsbury Drive (no number) La Trobe University Bundoora 3086 Victoria
Country 137443 0
Australia
Phone 137443 0
+61 9479 5081
Fax 137443 0
Email 137443 0
[email protected]
Contact person for scientific queries
Name 137444 0
Della Forster
Address 137444 0
Judith Lumley Centre Level 3, George Singer Building Kingsbury Drive (no number) La Trobe University Bundoora 3086 Victoria
Country 137444 0
Australia
Phone 137444 0
+61 3 9479 8783
Fax 137444 0
Email 137444 0
[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
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• To be discussed with Professor Della Forster when request is made.

When can requests for individual participant data be made (start and end dates)?
From:
Post completion of trial. No end date planned.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By request of Principle investigator Professor Della Forster (email: [email protected]).

Are there extra considerations when requesting access to individual participant data?
No


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.