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Trial registered on ANZCTR


Registration number
ACTRN12622001462774
Ethics application status
Approved
Date submitted
27/09/2022
Date registered
17/11/2022
Date last updated
17/11/2022
Date data sharing statement initially provided
17/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
To Be Born Upon a Pandanus Mat- Redesigning maternity services for Yolngu mothers and babies living on Elcho Island Northern Territory (NT), using Birthing on Country principles and the RISE translational Framework, to reduce preterm birth and improve health outcomes: A prospective, non-randomised, intervention trial
Scientific title
Investigating the effect of Birthing on Country redesign on maternal and infant health outcomes, including preterm births for Yolngu mothers and babies living on Elcho Island Northern Territory (NT) compared to baseline: A prospective, non-randomised, intervention trial
Secondary ID [1] 307126 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Pandanus Mat Partnership Project (PMPP)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm birth 325662 0
Infant health 325663 0
Condition category
Condition code
Public Health 323028 323028 0 0
Health service research
Reproductive Health and Childbirth 323029 323029 0 0
Antenatal care
Reproductive Health and Childbirth 323030 323030 0 0
Breast feeding
Reproductive Health and Childbirth 323031 323031 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 323032 323032 0 0
Complications of newborn
Reproductive Health and Childbirth 323033 323033 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
'Birthing on Country' service will be established in Galiwin’ku, Elcho Island, Arnhem Land, Darwin, Australia, a very remote, demonstration site. We will partner with key stakeholders through our community-based Participatory Action Research approach to redesign very remote maternity services and increase support for Yolngu women in both the primary and tertiary setting. The intervention will commence in 2023 and continue throughout the duration of the five-year project. Prospective qualitative and quantitative data will be collected and regularly reviewed throughout the intervention phase to assess intervention compliance and fidelity. Through the co-design process data variables will be identified and then reported on.

Key components of the intervention include:
• Multi-agency Partnership Committee providing culturally responsive overarching governance (of redesign and research), leadership and community engagement in co-designing care interventions
• Antenatal care interventions using Indigenous knowledges will be co-designed to address modifiable preterm risk factors. A midwife will always be available on site in Galiwin’ku. (Antenatal care interventions will be codesigned with Yolngu Cultural Authortities, djakamirr and midwives. Intervention elements will likely include continuity of care, enhancing reproductive health literacy, enabling early care access and privelleging First Nations languages and knowledge. )
• Women have 24/7 phone access to midwife or djakamirr (Indigenous doula).
• Women are flown to either Darwin or Nhulunbuy for specialist antenatal appointments and at term for a planned hospital birth.
• A midwifery group practice (remote MGP) will be established in Nhulunbuy (one already exists in Darwin) where midwives work in partnership with djakamirr with weekly teleconference to the remote team. (Midwifery group practices are well described in Australian maternity literature. We will follow this evidence base alongside remote clinical practice guidelines stipulated in the Minymaku Kutju Tjukurpa Women’s Business Manual to provide comprehensive maternity care for Yolngu women and families across the pregnancy, childbirth, and postnatal continuum. Teleconferences will be used as needed to discuss clinical priorities, undertake continuous quality improvement, deliver professional development, and review barriers/challenges. )
• All women are cared for during labour from a known midwife and/or djakamir. (Djakamirr care will commence as soon as a woman presents to services and consents to receiving djakamirr care, with an emphasis of care commencing as soon as possible in the first trimester of pregnancy. This will predominantly be face- to- face support and education and we anticiapte that two djakamirr care packages will be delivered each trimester alongside a transfer, birth, and post-natal care package. )
• After birth, when the women and baby return to the community, the midwife and djakamirr provide postnatal care and access to other support services as required (case managed). Djakamirr and Strong Women Workers and support agencies to continue engagement and support up to 2-years.
• Djakamirr care during pregnancy and childbirth is provided by an employed Strong Women Worker, who has undergone accredited Western and Yolngu training.
• Djakamirr will facilitate informed consent of all procedures in the woman’s primary language in and out of business hours.
• Care is delivered in the women’s first language. Djakamirr workforce will be increased to at least 4-FTE.
• Frontline staff are provided with regular clinical and cultural supervision with a focus on effective intercultural communication and working with Interpreters. (Frontline staff will be provided a package of Clinical Mentoring and Reflective Supervision. Clinical Mentoring delivered by an experienced Endorsed Midwife will be available 24/7 via phone. Reflective Supervision will be delivered by a clinical psychologist via regular one-hour fortnightly sessions. Depending on location and challenges of remote access this may include face-to-face, online meeting platform or by phone. )
• A community-based hub provides a culturally responsive and safe place for women, families, caregivers and Elders to undertake cultural activities that allow connection, sharing and learning from each other within a strength-based approach to birthing and parenting.
• There is access to early pregnancy testing and transport services, a strong emphasis on hunting and collecting (exercise) iron rich traditional foods (e.g. shellfish), with regular cook-ups and cultural activities.
• Established referral pathways between services and to community support agencies
Intervention code [1] 323144 0
Treatment: Other
Comparator / control treatment
Historical control group are women who carried an Indigenous baby and pregnnacy ended between 01/01/2015 -31/12/2022 and received maternity care in Galiwin'ku Miwatji Health Service. Data will be collected from NT Perinatal Trends Dataset and Miwatji Communicare database.

Characteristics of the standard care:
• No multi-agency oversight of maternity services
• Antenatal care is received from community-based nurse, midwife or doctor. Midwives are not always available on site in Galiwin’ku due to staff shortages.
• No 24/7 phone access to a known midwife or djäkamirr.
• Women are flown to either Darwin or Nhulunbuy for specialist antenatal appointments and at term for a planned hospital birth.
• Hospital-based midwives and doctors rotate on rosters through the service but do not visit the communities. Once a month teleconference between remote midwife, Nhulunbuy GP Obs., & Midwifery Unit manager occurs. Nhulunbuy midwife is allocated a woman and is responsible for ensuring their hospital file is up to date. A midwife may wish to use ‘flexi-hours’ (ad-hoc) to be with this woman but no robust system to trigger continuity of carer on arrival to hospital. Birthing support is provided from a roster of midwives and may be a midwife the woman has never met.
• After birth when the women and baby return to the community, postnatal care may be provided by a nurse, midwife, or doctor. Strong Women Workers and support agencies provide ad-hoc support in infancy.
• Services communicate with referrals and discharge summaries via electronic mail (+/-phone). These are often missing or late.
• Only 1-FTE Strong Woman Worker currently employed in the community who has limited access to appropriate tools and resources for supporting women during preganancy and labour. One Aboriginal Liaison Officer employed during business hours to provide maternity support in hospital. Outside of business hours there are no Yolngu care providers.
• All standard care episodes are delivered in English -a foreign language for the majority of Yolngu women.
• No ongoing provision of cultural training and clinical supervision. Ad hoc training on effective intercultural communication and how to work with Interpreters.
• Community-based maternity staff may not be aware of local support services (apart from baby-hub and Maternal Early Childhood Sustained Home-visiting program staff) and do not regularly meet with them. Cultural activities may occur ad-hoc.
• There are no referral pathways (from hospital) to connect women with support agencies available in the remote community; and care givers are unaware of community-based agencies and cultural support resources.


Control group
Historical

Outcomes
Primary outcome [1] 330774 0
Proportion of women giving birth preterm (<37 weeks gestation).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [1] 330774 0
Birth
Primary outcome [2] 330776 0
Proportion of women who attend antenatal care within first trimester (<14 weeks).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [2] 330776 0
At the time of booking in for antenatal care
Primary outcome [3] 330777 0
Proportion of women who have a Primary Postpartum Haemorrhage (greater than or equal to 500ml within 24 hours of birth).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [3] 330777 0
24 hours post delivery
Secondary outcome [1] 407516 0
Antenatal care attendance (>=5 visits, <5 visits).
The number of antenatal visits will be extracted from NT Perinatal Trend Dataset.
Timepoint [1] 407516 0
Birth
Secondary outcome [2] 407517 0
Smoking after 20 weeks gestation (yes/no).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [2] 407517 0
Birth
Secondary outcome [3] 407518 0
Alcohol consumption at 36 weeks (yes/no)
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [3] 407518 0
36 weeks gestation
Secondary outcome [4] 407660 0
Djakamirr present during birth (yes/no)
Data will be extracted from database designed for the study
Timepoint [4] 407660 0
Birth
Secondary outcome [5] 407661 0
A known midwife present during birth (yes/no)
Data will be extracted from database designed for the study
Timepoint [5] 407661 0
Birth
Secondary outcome [6] 407662 0
Care from an MGP midwife during birth.
The data will be extracted from NT Perinatal Trend Dataset
Timepoint [6] 407662 0
Birth
Secondary outcome [7] 407663 0
Pregnancy complications: pregnancy induced hypertension (yes/no)
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [7] 407663 0
Birth
Secondary outcome [8] 407664 0
Analgesia in labour (regional analgesia [epidural/spinal], narcotic analgesia, nitrous oxide gas).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [8] 407664 0
Birth
Secondary outcome [9] 407665 0
Onset of labour (induced, no labour, spontaneous)
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [9] 407665 0
Birth
Secondary outcome [10] 407666 0
Mode of birth (non-instrumental vaginal birth, instrumental vaginal birth, caesarean section).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [10] 407666 0
Birth
Secondary outcome [11] 407667 0
Timing of caesarean section (emergency caesarean section, elective caesarean section).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [11] 407667 0
Birth
Secondary outcome [12] 407668 0
Vaginal birth after caesarean section.
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [12] 407668 0
Birth
Secondary outcome [13] 407669 0
Perineal status (intact/1st degree tear, 2nd degree tear, 3rd/4th degree tear).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [13] 407669 0
Birth
Secondary outcome [14] 407670 0
Normal birth (>=37 weeks, vertex presentation, spontaneous onset of labour, no regional analgesia, spontaneous vaginal birth, no episiotomy).
This composite outcome will be calculated using data extracted from NT Perinatal Trend Dataset.
Timepoint [14] 407670 0
Birth
Secondary outcome [15] 407671 0
Birthplace (Royal Darwin Hospital, Gove District Health Centre, Planned Home, other), born before arrival (yes/no)
The data will be extracted from NT Perinatal Trend Dataset and NT Inpatient Activity Dataset.
Timepoint [15] 407671 0
Birth
Secondary outcome [16] 407672 0
Separation mode of mother (Discharged to usual residence, Transfer to another hospital, Died, Left against advice, Other, Unknown).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [16] 407672 0
Birth
Secondary outcome [17] 407673 0
Neonatal outcome at birth (livebirth, stillbirth).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [17] 407673 0
Birth
Secondary outcome [18] 407674 0
Proportion of babies admitted to a separate neonatal nursery (Level 2 in Nhulunbuy or higher-level care in Darwin)-This is a primary outcome.
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [18] 407674 0
At discharge from hospital following birth
Secondary outcome [19] 407676 0
Infant admission to hospital up to 28 days of age (yes/no).
The data will be extracted from NT Inpatient Activity Dataset.
Timepoint [19] 407676 0
28 days after birth
Secondary outcome [20] 407677 0
Mode of separation of baby from hospital of birth (Discharge to usual residence, Transfer to another acute hospital, Transfer to another acute hospital and died, Stillborn/Neonatal death (hospital of birth), Other).
The data will be extracted from NT Perinatal Trend Dataset.
Timepoint [20] 407677 0
At discharge from hospital following birth
Secondary outcome [21] 407678 0
Emergency evacuation flights from remote community (yes/no).
This data will be extracted from CareFlight dataset.
Timepoint [21] 407678 0
Birth
Secondary outcome [22] 407679 0
Mother’s duration of total stay in hospital (days).
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [22] 407679 0
After discharge from hospital following birth
Secondary outcome [23] 407680 0
Infant length of stay in neonatal nursery (hours).
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [23] 407680 0
At discharge from hospital following birth
Secondary outcome [24] 407682 0
Neonatal deaths prior hospital discharge (<=28 days).
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [24] 407682 0
At discharge from hospital following birth or 28 days after birth if discharged early
Secondary outcome [25] 407683 0
Healthy baby (live born, singleton, >=37 weeks gestation, 2,500-4,499g birthweight, Apgar score at five minutes >=7).
This composite outcome will be calculated using data extracted from NT Perinatal Trend Dataset.
Timepoint [25] 407683 0
Birth
Secondary outcome [26] 407684 0
Child Safety unborn notification and child removal up to 28 days.
The data will be extracted from database designed for the study.
Timepoint [26] 407684 0
1 month postpartum
Secondary outcome [27] 407685 0
The intended place of birth at the onset of labour (Royal Darwin Hospital, Gove District Health Centre, Planned Home, other).
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [27] 407685 0
Birth
Secondary outcome [28] 409010 0
Low birth weight (<2500g)-this is a primary outcome.
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [28] 409010 0
Birth
Secondary outcome [29] 409011 0
Breastfeeding status at discharge (exclusive, mixed, formula only).
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [29] 409011 0
At discharge from hospital following birth
Secondary outcome [30] 409012 0
Augmentation of labour (yes/no).
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [30] 409012 0
Birth
Secondary outcome [31] 409017 0
Episiotomy (yes/no)
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [31] 409017 0
Birth
Secondary outcome [32] 409018 0
Apgar score at 5 minutes (less than 7, greater than or equal to 7)
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [32] 409018 0
Five minutes after birth
Secondary outcome [33] 409019 0
Length of facility stay for mothers following birth (days)
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [33] 409019 0
Discharge from hospital
Secondary outcome [34] 409027 0
Neonatal respiratory resuscitation (yes/no)
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [34] 409027 0
Ten minutes after birth
Secondary outcome [35] 414934 0
Length of facility stay for infant (day)
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [35] 414934 0
Discharge from hospital
Secondary outcome [36] 414935 0
Pregnancy complications: antenatal haemorrhage (yes/no).
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [36] 414935 0
Birth
Secondary outcome [37] 414936 0
Pregnancy complications: gestational diabetes (yes/no)
This data will be extracted from NT Perinatal Trend dataset.
Timepoint [37] 414936 0
Birth
Secondary outcome [38] 415615 0
Cost of care per mother/infant pair during pregnancy, birth, and postnatal until mother 6 weeks postpartum and baby 28 days after birth (DRG and ICD code for hospital admissions) -data derived from NT Perinatal Database and Miwatji Communicare.
Timepoint [38] 415615 0
6 weeks postnatal

Eligibility
Key inclusion criteria
All women in Galiwin’ku, Elcho Island, Arnhem Land who carry an Indigenous baby and give birth between 2015 and 2027 will be included in our study: pre-intervention cohort (2015-2022) vs post intervention cohort (2023-2027). Women who did not carry an Indigenous baby will be excluded from the study.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who did not carry an Indigenous baby will be excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study design is non-randomised, prospective interventional cohort compared to prospectively entered historical control cohort. The historical control cohort includes all women who carried an Indigenous baby whose pregnancy ended during 01/01/2015-31/12/2022 and received maternity care in Galiwin'ku Miwatji Health Service. The interventional cohort includes all women who carried an Indigenous baby whose pregnancy ended during 01/01/2023-31/12/2027 and received maternity care in Galiwin'ku Miwatji Health Service.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We employed a sample size calculation strategy in line with the small number of births in our study community (~50 births per year), and to keep the post intervention implementation period to the maximum study funding timeframe). The pre-intervention control cohort will be standard care from 2015 to 2022. While most of the pre-intervention data will be collected retrospectively (~50% of total sample size), a small amount (~10%) will be collected prospectively the same as our prospective post intervention data (~ 40% of total sample size). The sample size was calculated based on our main primary outcome measure (preterm birth), with the intervention expected to lead to a reduction of preterm birth rate from 22% to 12% (Odds Ratio 0.5). To detect this difference with 80% power and a type 1 error rate of 5%, after excluding ~7% of babies (multiple births / fetal anomaly) and ~10% missing records, 552 women in total are needed, of which 330 will be in the pre-intervention and 222 in the post intervention group. We ensured the above sample size was also sufficient to detect a clinically significant difference for all primary outcomes with at least 80% power.

We will compare the difference in maternal and child health outcomes between the pre and post intervention cohorts. Initial bivariate analysis will investigate possible differences between the cohorts for baseline socio-demographic (socio-economic status), and clinical characteristics (e.g. age, parity, BMI, smoking, obstetric history etc) that could affect outcomes. Dependent on data type, preliminary analysis will be undertaken using independent samples t-tests, Mann-Whitney U tests or Chi-squared tests. Descriptive statistics will be reported as: means and standard deviations for continuous variables and number and percentages for categorical variables. For the formal modelling, linear regression will be employed for continuous outcomes, and logistic regression will be used for categorical outcomes (binary, multinomial and ordinal) yielding odds ratios and their 95% confidence intervals. All unadjusted effects will be generated using bivariate regression models (linear or logistic, as appropriate) whereas adjusted effect sizes will be estimated using propensity score adjustment based on inverse probability of treatment weighting (ITPW). Any confounders identified from literatures and our previous studies will be adjusted. Analysis will be performed with Stata or R and statistical significant is set as p<0.05.

We will examine the cost-effectiveness of the Djäkamirr Support Program and health service redesign. The time horizon begins with the first presentation for antenatal care and includes the birth episode, postnatal care in hospital and communities up to six weeks after birth, readmissions up to six weeks postnatally for mothers and up to 28 days after birth for infants. The number of preterm births after service redesign is used as the effectiveness measures in the cost-effectiveness analysis. Cost analyses will include measures of arithmetic means, between-group differences, variability of differences, and testing for statistical difference. The incremental cost effectiveness ratio (ICER) will be calculated as the arithmetic mean different in cost between two groups divided by the arithmetic mean difference in effect. The cost effectiveness scatterplots and cost-effectiveness acceptability curves will be explored to quantify the level of decision uncertainty.

We will conduct a cost-benefit analysis to assess the broad, long-term societal consequences of Birthing on Country service redesign that are not captured in above cost-effectiveness analysis. We will conduct a lifetime horizon (from birth until death) analysis for this cohort. Decision-analytical modelling will be employed to compare a cohort of First Nation infants born with Birthing on Country to the status quo for in Galiwinku.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
29/02/2028
Actual
Sample size
Target
552
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 21982 0
Gove District Hospital - Nhulunbuy
Recruitment hospital [2] 21983 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 37082 0
0880 - Gove
Recruitment postcode(s) [2] 37084 0
0810 - Tiwi
Recruitment postcode(s) [3] 37522 0
0822 - Galiwinku

Funding & Sponsors
Funding source category [1] 311028 0
Government body
Name [1] 311028 0
NHMRC
Country [1] 311028 0
Australia
Primary sponsor type
University
Name
Charles Darwin University
Address
Ellengowan Drive, Casuarina NT 0810
Country
Australia
Secondary sponsor category [1] 312349 0
None
Name [1] 312349 0
Address [1] 312349 0
Country [1] 312349 0
Other collaborator category [1] 282220 0
Government body
Name [1] 282220 0
Department of Health NT
Address [1] 282220 0
87 Mitchell Street, Darwin NT 0800
Country [1] 282220 0
Australia
Other collaborator category [2] 282221 0
Other Collaborative groups
Name [2] 282221 0
Yalu Marnggithinyaraw Cultural Knowledge Centre
Address [2] 282221 0
Riyalanura Road, Galiwinku NT 0822
Country [2] 282221 0
Australia
Other collaborator category [3] 282222 0
Other Collaborative groups
Name [3] 282222 0
Miwatj Health Aboriginal Corporation
Address [3] 282222 0
1424 Arnhem Road, Nhulunbuy NT 0880
Country [3] 282222 0
Australia
Other collaborator category [4] 282223 0
Commercial sector/Industry
Name [4] 282223 0
CareFlight Northern Operations (NT)
Address [4] 282223 0
12 Lancaster Rd, Eaton (Darwin Airport), NT 0820
Country [4] 282223 0
Australia
Other collaborator category [5] 282224 0
Charities/Societies/Foundations
Name [5] 282224 0
Australian Red Cross
Address [5] 282224 0
GPO Box 9949, Melbourne VIC 3001
Country [5] 282224 0
Australia
Other collaborator category [6] 282225 0
Commercial sector/Industry
Name [6] 282225 0
Australian Doula College
Address [6] 282225 0
Level 5, 203-233 New South Head Road, Edgecliff NSW 2027
Country [6] 282225 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310576 0
Human Research Ethics Committee of the NT Departments of Health and Menzies School of Health Research
Ethics committee address [1] 310576 0
Ethics committee country [1] 310576 0
Australia
Date submitted for ethics approval [1] 310576 0
30/03/2022
Approval date [1] 310576 0
23/05/2022
Ethics approval number [1] 310576 0
2022-4291

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

Contacts
Principal investigator
Name 118138 0
Prof Yvette Roe
Address 118138 0
Molly Wardaguga Research Centre
Charles Darwin University
Ellengowan Drive, Casuarina NT 0810
Country 118138 0
Australia
Phone 118138 0
+61 8 8946 7668
Fax 118138 0
Email 118138 0
yvette.roe@cdu.edu.au
Contact person for public queries
Name 118139 0
Yvette Roe
Address 118139 0
Molly Wardaguga Research Centre
Charles Darwin University
Ellengowan Drive, Casuarina NT 0810
Country 118139 0
Australia
Phone 118139 0
+61 8 8946 7668
Fax 118139 0
Email 118139 0
yvette.roe@cdu.edu.au
Contact person for scientific queries
Name 118140 0
Sue Kildea
Address 118140 0
Molly Wardaguga Research Centre
Charles Darwin University
10 Grevillea Drive, Sadadeen NT 0870
Country 118140 0
Australia
Phone 118140 0
+61 418289199
Fax 118140 0
Email 118140 0
sue.kildea@cdu.edu.au

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 individual participant data of published results only
When will data be available (start and end dates)?
2028-2029
Available to whom?
Case-by-case basis at the direction of Chief Investigator and Steering Committee
Available for what types of analyses?
To achive the aims in the approved proposal
How or where can data be obtained?
The datasets generated an/or analysed during the current study may be available from the Chief Investigator (Yvette.roe@cdu.edu.au and Sue.kildea@cdu.edu.au) on reasonable request pending approval by the Steering Committee to ensure Indigenous data sovereignty guidelines are adhered to.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15852Study protocol  mwrc.admin@cdu.edu.au
15853Statistical analysis plan  mwrc.admin@cdu.edu.au
15854Ethical approval  mwrc.admin@cdu.edu.au 383770-(Uploaded-27-09-2022-17-31-03)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.