Trial Review

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
ACTRN12623000895684
Ethics application status
Approved
Date submitted
28/07/2023
Date registered
21/08/2023
Date last updated
21/08/2023
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
RISE SAFELY in remote Australia - Redesigning maternity services for First Nations mothers and babies living in Central Australia, Northern Territory (NT), using Birthing on Country principles and the RISE implementation Framework, to address preterm birth and 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 First Nations mothers and babies living in Central Australia, Northern Territory (NT) compared to baseline: A prospective, non-randomised, intervention trial.
Secondary ID [1] 310108 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Birth 330676 0
Infant Health 330677 0
Maternal Health 330678 0
Condition category
Condition code
Public Health 327489 327489 0 0
Health service research
Reproductive Health and Childbirth 327490 327490 0 0
Antenatal care
Reproductive Health and Childbirth 327491 327491 0 0
Breast feeding
Reproductive Health and Childbirth 327492 327492 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 327493 327493 0 0
Complications of newborn
Reproductive Health and Childbirth 327494 327494 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 'Birthing on Country' service will be established in Mparntwe, Alice Springs, Central Arrernte Country, Central Australia, Northern Territory (NT) a remote, demonstration site . We will partner with key stakeholders through our community-based Participatory Action Research (PAR) approach to redesign a remote maternity service and increase support for First Nations women in both the primary and tertiary setting.

Key components of the intervention include:
- Multi-agency Partnership Committees and working parties providing culturally responsive overarching governance and leadership of redesign of maternity services and research, community engagement in co-designing care interventions.
- Antenatal care is provided at the Alukura Hub or woman’s home, other Congress clinics or location of woman’s choice by a named (primary) midwife in collaboration with the Alukura GP and ASH antenatal services. Alukura maternity services work in partnership with ASH Diabetes AnteNatal Care and Education clinic (DANCE) to support women with diabetes. DANCE provides specialist input in care of the women. Congress Alukura midwives, GP and diabetes nurse educator (DNE) meet weekly with ASH DANCE staff. Assist women with monitoring blood glucose levels (BGL), provide medication and testing supplies and education about self- management.
- Antenatal care interventions using First Nations knowledges will be co-designed to address modifiable preterm risk factors. This will be determined by the Congress Women's Health Committee and may include hunting trips, cultural camps, cultural days and other activities. Co-design will be lead by the Congress Women's Health Committee and Elders who attend weekly cultural days working in partnership with the Alukura and My Midwives teams, the hospital services and the research team. We may also have annual or biannual Women's Camps where further guidance is provided. Activities will occur after deep listening activities that enable guidance from the Elders.
- Midwives follow the Australian College of Midwives National Midwifery Guidelines for Consultation and Referral and use the CARPA Minymaku Kutju Tjukurpa Women’s Business Manual as a guide for practice. When women are Categorised as B, midwives consult with the GP obstetrician at Alukura or the specialist at ASH. When women are Category C, midwives consult with the specialist at ASH to plan a specialist antenatal appointment and ongoing care however women will continue to receive continuity of care by their named midwife and receive specialist input as required at Alukura or ASH (E.g. telehealth appointments with DANCE clinic and input from DNE).
- Women have 24/7 phone access to a known midwife.
- A midwifery group practice (Midwifery group practices are well described in Australian maternity literature) will be established at Alukura (AMGP) where midwives work in partnership with the Congress support services with weekly teleconference to the remote teams if women are transiting between remote and urban. All women are cared for during labour from a known midwife with support from ASH staff as required. Postnatal care in hospital primarily provided by ASH staff. Teleconferences will be used as needed to discuss clinical priorities, undertake continuous quality improvement, deliver professional development, and review barriers/challenges.
- After birth, when the women and baby return to the community, the midwife and Congress support services provide postnatal care up to 6-weeks. Postnatal care is delivered according to need and usually includes regular visits up to 6-weeks postnatal where mother and baby are supported with breastfeeding, care of the newborn (bathing, sleeping, settling) and other postnatal activities in line with the CARPA guidelines.
- Verbal and written handover of care for every transfer between services (AMGP to or from ASH or remote and to child health services).
- Women are referred to Congress support services (e.g. Australian Nurse Family Partnership team [ANFPP] and Intensive Family Support Service [IFSS] if they meet the criteria). Aim is to grow the Family Support Workers to ensure each midwife is working side-by-side with a Congress Family Support Worker who provides social and emotional wellbeing and practical support to all women across the maternity journey (if not accessing other services). Aim is to recruit and embed 2-student midwives into this service.
- Frontline staff are provided with clinical mentoring and reflective supervision with a focus on clinical and cultural safety, effective intercultural communication, and working together.
- 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. Community days will occur once a week with all women encouraged to attend.
- Strategies to monitor adherence to the intervention will be through patient medical records.
- The duration of the intervention will be commencing in September 2023 and ongoing as a sustainable service after data collection ends.
Intervention code [1] 326507 0
Treatment: Other
Comparator / control treatment
Historical control group are all women in the Congress Communicare data as receiving antenatal care (including women who have recorded a miscarriage or a termination of pregnancy) and those who have given birth to a First Nations baby inside or outside of NT (interstate interhospital transfer) 7 years prior to intervention starts. Data will be collected from Congress Communicare database and NT Perinatal Data Collection.

Characteristics of standard care:
- No First Nations oversight of maternity services
- Antenatal care is provided at the Alukura Hub, other Congress clinics, by a general practitioner or with the Alukura GP and ASH antenatal services (a dedicated outreach obstetrician visits Alukura regularly and other specialized services are available at the hospital e.g. the diabetic clinic).
- Midwives follow the National Midwifery Guidelines for Consultation and Referral. When women categorised as B (midwives consult with the GP obstetrician at Alukura or the specialist at ASH). When women are category C (transfer) they are referred to the Alice Springs Hospital for specialist antenatal appointments but may also continue care at Alukura.
- No 24/7 phone access to a known (primary) midwife.
- Hospital-based midwives and doctors rotate on rosters through the service. 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 the hospital DOM (weekends) then handover to an Alukura midwife or community clinic of Congress ad hoc (i.e not case managed by a known provider).
- Services communicate with referrals and discharge summaries via electronic mail (+/-phone). These are often missing or late. Alukura midwives attend ASH 3 days per week to check/confirm if any clients have birthed that are known to the team that they have not been notified about.
- Women are referred to Congress support services (Australian Nurse Family Partnership team up to 2-years or Intensive Family Support Service if they meet the criteria) and if there is enough staff.
- No ongoing provision of mentoring and reflective supervision.
- Community-based maternity staff may not meet regularly with ANFPP and IFSS program staff). Cultural activities may occur ad-hoc.
Control group
Historical

Outcomes
Primary outcome [1] 335358 0
Proportion of women giving birth preterm (at least 20-weeks’ gestation or 400 grams birthweight and <37-weeks’ gestation). This outcome will be assessed via audit of patient medical records.
Timepoint [1] 335358 0
At the conclusion of study.
Primary outcome [2] 335359 0
Proportion of low-birth-weight babies (< 2500g). This outcome will be assessed via audit of patient medical records.
Timepoint [2] 335359 0
At the conclusion of study.
Primary outcome [3] 335360 0
Proportion of women who have antenatal contact within 1st trimester (<14 weeks). This outcome will be assessed via audit of patient medical records.
Timepoint [3] 335360 0
At the conclusion of study.
Secondary outcome [1] 424056 0
Primary Outcome: Mode of birth (caesarean section). This outcome will be assessed via audit of patient medical records.
Timepoint [1] 424056 0
Primary timepoint: at the conclusion of study.
Secondary outcome [2] 424057 0
Primary Outcome: Proportion of women who have had a primary postpartum haemorrhage (equal or more than 500ml within 24 hours of birth). This outcome will be assessed via audit of patient medical records.
Timepoint [2] 424057 0
Primary timepoint: at the conclusion of study.
Secondary outcome [3] 424058 0
Primary Outcome: Proportion of babies requiring admission under a paediatrician or neonatologist. This outcome will be assessed via audit of patient medical records.
Timepoint [3] 424058 0
Primary timepoint: at the conclusion of study.
Secondary outcome [4] 424059 0
Primary Outcome: Proportion of women receiving caseload care though a midwifery group practice during pregnancy and birth (feasibility of service implementation outcome). This outcome will be assessed via audit of patient medical records.
Timepoint [4] 424059 0
Primary timepoint: at the conclusion of study.
Secondary outcome [5] 424060 0
Antenatal care attendance (5 or more visits, <5 visits). This outcome will be assessed via audit of patient medical records.
Timepoint [5] 424060 0
At the conclusion of study.
Secondary outcome [6] 424061 0
The following secondary outcomes will be assessed separately: Smoking at third trimester (yes/no); Alcohol consumptions at third trimester (yes/no); Illicit drugs usage at third trimester (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [6] 424061 0
Birth.
Secondary outcome [7] 424062 0
Congress Family Support Worker present during birth (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [7] 424062 0
Birth.
Secondary outcome [8] 424063 0
The following secondary outcomes will be assessed separately: AMGP staff present during labour (yes/no); AMGP staff present during birth (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [8] 424063 0
Birth.
Secondary outcome [9] 424064 0
The following secondary outcomes will be assessed separately: Primary midwife present during labour (yes/no); Primary midwife present during birth (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [9] 424064 0
Birth.
Secondary outcome [10] 424065 0
Pregnancy-induced hypertension (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [10] 424065 0
Birth.
Secondary outcome [11] 424066 0
Antepartum haemorrhage (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [11] 424066 0
Birth.
Secondary outcome [12] 424067 0
Gestational diabetes (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [12] 424067 0
Birth.
Secondary outcome [13] 424068 0
Analgesia in labour (regional analgesia [epidural/spinal], narcotic analgesia, nitrous oxide gas). This outcome will be assessed via audit of patient medical records.
Timepoint [13] 424068 0
Birth.
Secondary outcome [14] 424069 0
The following secondary outcomes will be assessed separately: Onset of labour (induced, no labour, spontaneous); Augmentation of labour (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [14] 424069 0
Birth.
Secondary outcome [15] 424070 0
Mode of birth (non-instrumental vaginal birth, instrumental vaginal birth, caesarean section). This outcome will be assessed via audit of patient medical records.
Timepoint [15] 424070 0
Birth.
Secondary outcome [16] 424071 0
Timing of caesarean section (emergency caesarean section, elective caesarean section). This outcome will be assessed via audit of patient medical records.
Timepoint [16] 424071 0
Birth.
Secondary outcome [17] 424072 0
Vaginal birth after caesarean section. This outcome will be assessed via audit of patient medical records.
Timepoint [17] 424072 0
Birth.
Secondary outcome [18] 424073 0
The following secondary outcomes will be assessed separately: Perineal status (intact/1st degree tear, 2nd degree tear, 3rd/4th degree tear); Episiotomy (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [18] 424073 0
Birth.
Secondary outcome [19] 424074 0
Normal birth (>=37 weeks, vertex presentation, spontaneous onset of labour, no regional analgesia, spontaneous vaginal birth, no episiotomy). This outcome will be assessed via audit of patient medical records.
Timepoint [19] 424074 0
Birth.
Secondary outcome [20] 424075 0
The intended place of birth at the onset of labour. This outcome will be assessed via audit of patient medical records.
Timepoint [20] 424075 0
Birth.
Secondary outcome [21] 424076 0
Birthweight. This outcome will be assessed via audit of patient medical records.
Timepoint [21] 424076 0
Birth.
Secondary outcome [22] 424077 0
The following secondary outcomes will be assessed separately: Birthplace: Royal Darwin Hospital, Alice Springs Hospital, Tennant Creek Hospital, Planned Home, other; Born interstate (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [22] 424077 0
Birth.
Secondary outcome [23] 424078 0
Born before arrival (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [23] 424078 0
Birth.
Secondary outcome [24] 424079 0
Separation mode of mother (Discharged to usual residence, Transfer to another hospital, Died, Left against advice, Other, Unknown). This outcome will be assessed via audit of patient medical records.
Timepoint [24] 424079 0
Birth.
Secondary outcome [25] 424080 0
Neonatal outcome at birth (livebirth, stillbirth). This outcome will be assessed via audit of patient medical records.
Timepoint [25] 424080 0
Birth.
Secondary outcome [26] 424081 0
Respiratory neonatal resuscitation (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [26] 424081 0
Birth.
Secondary outcome [27] 424082 0
Apgar score at 5 minutes (<7, >=7). This outcome will be assessed via audit of patient medical records.
Timepoint [27] 424082 0
Birth.
Secondary outcome [28] 424083 0
Small for gestational age (SGA) at birth. This outcome will be assessed via audit of patient medical records.
Timepoint [28] 424083 0
Birth.
Secondary outcome [29] 424084 0
Length of stay in neonatal nursery (hours). This outcome will be assessed via audit of patient medical records.
Timepoint [29] 424084 0
At discharge from hospital following birth.
Secondary outcome [30] 424085 0
Breastfeeding status at discharge (exclusive, mixed, formula only). This outcome will be assessed via audit of patient medical records.
Timepoint [30] 424085 0
At discharge from hospital following birth.
Secondary outcome [31] 424086 0
Infant admission to hospital up to 28 days of age (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [31] 424086 0
28 days post birth.
Secondary outcome [32] 424087 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). This outcome will be assessed via audit of patient medical records.
Timepoint [32] 424087 0
At discharge from hospital following birth.
Secondary outcome [33] 424088 0
Emergency transfer during pregnancy, birth or postnatal (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [33] 424088 0
At discharge from hospital following birth.
Secondary outcome [34] 424089 0
The following secondary outcomes will be assessed separately: Mother’s and infant’s duration of total stay in hospital (mean, median, range); Length of facility stay for mothers and infants following birth. Each outcome will be assessed by audit of patient medical records.
Timepoint [34] 424089 0
At discharge from hospital following birth.
Secondary outcome [35] 424090 0
Neonatal deaths prior to hospital discharge (within 28 days). This outcome will be assessed via audit of patient medical records.
Timepoint [35] 424090 0
28 days post birth.
Secondary outcome [36] 424091 0
Healthy baby (live born, singleton, >=37 weeks gestation, 2,500-4,499g birthweight, Apgar score at five minutes 7 or higher). This outcome will be assessed via audit of patient medical records.
Timepoint [36] 424091 0
Birth.
Secondary outcome [37] 424092 0
Child Safety unborn notification and child removal up to 28 days. This outcome will be assessed via audit of patient medical records.
Timepoint [37] 424092 0
28 days post birth.
Secondary outcome [38] 424093 0
Cultural identity and empowerment (measured through the Growth and Empowerment Measure).
Timepoint [38] 424093 0
Early pregnancy (first or second trimester) and six weeks postpartum.
Secondary outcome [39] 425276 0
Incremental cost-effectiveness ratio (ICER). The total costs from 1st presentation to 6 weeks after birth including antenatal costs, birthing costs, postnatal costs and neonatal costs, for both intervention and control, will be estimated. Data will be sourced from routinely collected medical records. The effect will be measured in terms of preterm birth rate.
Timepoint [39] 425276 0
At the conclusion of study.

Eligibility
Key inclusion criteria
All women who are registered in the Congress Communicare database as receiving antenatal care (including women who have recorded a miscarriage or a medical/surgical termination of pregnancy) and those who have given birth to a First Nations baby inside or outside of NT, during the study period: pre-intervention cohort (2016-2022) vs post intervention cohort (2023-2027) will be included.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who did not carry a First Nations 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. Historical control group includes all women in the Congress Communicare data as receiving antenatal care (including women who have recorded a miscarriage or a termination of pregnancy) and those who have given birth to a First Nations baby inside or outside of NT (interstate interhospital transfer) between 2016- 2022. The interventional cohort includes all women in the Congress Communicare data as receiving antenatal care (including women who have recorded a miscarriage or a termination of pregnancy) and those who have given birth to a First Nations baby inside or outside of NT (interstate interhospital transfer) between 2023-2027. Upon ethics approval the specific month of post intervention cohort data collection will be determined.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
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 14.6% to 9.3% (Odds Ratio 0.6); similar to the findings in our BiOC study (Kildea et al, 2021). 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, 1402 women in total are needed, of which 882 will be in the pre-intervention and 520 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. In 2018 there were 139 Aboriginal women gave birth at Alice Springs Urban. We are expecting to complete recruitment in five years.

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 the literature and our previous studies will be adjusted. Analysis will be performed with Stata or R and statistical significance is set as p<0.05.
We will examine the cost-effectiveness of the Alukura Midwifery Group Practice and health service redesign. The time horizon starts from 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. We will conduct an intention-to-treat in comparison of the two groups, pre and post intervention, respectively. 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
29/02/2028
Actual
Sample size
Target
520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 25130 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 40797 0
0870 - Alice Springs
Recruitment postcode(s) [2] 41150 0
2541 - Nowra

Funding & Sponsors
Funding source category [1] 314268 0
Government body
Name [1] 314268 0
NHMRC
Country [1] 314268 0
Australia
Primary sponsor type
University
Name
Charles Darwin University
Address
Ellengowan Drive, Casuarina, NT 0810, Australia
Country
Australia
Secondary sponsor category [1] 316210 0
None
Name [1] 316210 0
Address [1] 316210 0
Country [1] 316210 0
Other collaborator category [1] 282756 0
Government body
Name [1] 282756 0
Department of NT Health
Address [1] 282756 0
87 Mitchell Street, Darwin, NT 0800, Australia
Country [1] 282756 0
Australia
Other collaborator category [2] 282757 0
Other Collaborative groups
Name [2] 282757 0
Central Australian Aboriginal Congress
Address [2] 282757 0
14 Leichardt Terrace Alice Springs NT 0873, Australia
Country [2] 282757 0
Australia
Other collaborator category [3] 282758 0
Other Collaborative groups
Name [3] 282758 0
My Midwives
Address [3] 282758 0
1 Windsor Road, Red Hill, QLD 4059
Country [3] 282758 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313387 0
Human Research Committee of the NT Department of Health and Menzies School of Research
Ethics committee address [1] 313387 0
Menzies School of Health Research PO Box 41096 Casuarina NT 0811
Ethics committee country [1] 313387 0
Australia
Date submitted for ethics approval [1] 313387 0
25/01/2023
Approval date [1] 313387 0
18/05/2023
Ethics approval number [1] 313387 0
2023-4528

Summary
Brief summary
The study aims to establish and evaluate Australia’s ‘Birthing on Country’ remote, demonstration site in Mparntwe, Alice Springs, Northern Territory. We will redesign the health service to increase continuity and quality of maternity care, and positively impact the health and wellbeing of First Nations women and babies in Central Australia. The clinical, cultural and cost effectiveness, and acceptability, of the new service will be systematically evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127974 0
Prof Yvette Roe
Address 127974 0
Molly Wardaguga Reseach Centre, Charles Darwin University, Ellengowan Drive, Casurarina NT 0810
Country 127974 0
Australia
Phone 127974 0
+61 88946 7668
Fax 127974 0
Email 127974 0
[email protected]
Contact person for public queries
Name 127975 0
Prof Yvette Roe
Address 127975 0
Molly Wardaguga Reseach Centre, Charles Darwin University, Ellengowan Drive, Casurarina NT 0810
Country 127975 0
Australia
Phone 127975 0
+61 88946 7668
Fax 127975 0
Email 127975 0
[email protected]
Contact person for scientific queries
Name 127976 0
A/Prof Sue Kildea
Address 127976 0
Molly Wardaguga Research Centre, Charles Darwin University, 10 Grevillea Drive Sadadeen NT 0870
Country 127976 0
Australia
Phone 127976 0
+61 418289199
Fax 127976 0
Email 127976 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 individual data of published results only
When will data be available (start and end dates)?
Up to steering committee when the data is available
Available to whom?
Case-by-case basis at the direction of Chief Investigator and Steering Committee
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
The datasets generated and/or analysed during the current study may be available from the Chief Investigator ([email protected] and [email protected]) 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
19683Study protocol  [email protected]
19684Statistical analysis plan  [email protected]
19685Ethical approval  [email protected]



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.