Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000571875
Ethics application status
Approved
Date submitted
8/03/2021
Date registered
17/05/2021
Date last updated
22/09/2024
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
ACORN: Approaches to Consent for Routine Data Linkage in Neonatal Follow-Up
Scientific title
The influence of different approaches to requesting consent on rates of consent for routine data linkage in neonatal follow-up (ACORN): A 2x2 factorial randomised trial
Secondary ID [1] 303621 0
Nil known
Universal Trial Number (UTN)
U1111-1264-8485
Trial acronym
ACORN (Approaches to Consent for Routine Data Linkage in Neonatal Follow-Up)
Linked study record
This trial is nested within the 6–7-year follow-up of participants in the following neonatal randomised trials: Hypoglycaemia Prevention with Oral Dextrose gel (pre-hPOD, ACTRN12613000322730 and hPOD, ACTRN12614001263684) and The Impact of Protein Intravenous Nutrition on Development in Extremely Low Birthweight Babies (ProViDe, ACTRN12612001084875).

Health condition
Health condition(s) or problem(s) studied:
Rates of parental consent to researchers accessing routinely collected data about their children. 321004 0
Condition category
Condition code
Public Health 318810 318810 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents of children who participated in the primary trials and are contacted for consent to in person follow-up assessments when the child is 6-7 years of age will be randomised to being asked for consent to researchers accessing routinely collected data about their children using different approaches in a factorial design:

Factor 1: Concurrent vs delayed consent
- Concurrent consent: Consent to data linkage will be requested at the same time as consent to the in-person follow-up assessment.
- Delayed consent: Consent to data linkage will be requested after the in-person follow-up assessment, mailed along with the letter summarising the findings of the in-person assessment. This will be approximately one month after the in-person assessment.

Factor 2: Separate vs combined consent
- Separate consent: Consent to data linkage for health and education data will be requested separately, as two different questions on the consent form.
- Combined consent: Consent to data linkage of health and education data will be requested together, as a single question on the consent form.

All other details of the consent forms, and information provided to participants will be otherwise identical.
Intervention code [1] 319918 0
Other interventions
Comparator / control treatment
It is usual for researchers to seek consent for all aspects of participation in a study at the same time. This approach of concurrent consent will therefore be compared with delayed consent for data linkage after the in-person assessment has been completed. Therefore, the comparator for the concurrent/delayed factor will be concurrent consent.

In addition, researchers often provide options for participants to consent to or decline some aspects of the study rather than having to agree to or decline all components of the study as a whole. We will therefore compare separate consent for linkage of health and education data with consent for both health and education data combined. Therefore, the comparator for the combined/separate factor will be separate consent.

The four conditions will be:
Condition 1: concurrent, separate consent (no intervention);
Condition 2: concurrent, combined consent (one intervention);
Condition 3: delayed, separate consent (one intervention);
Condition 4: delayed, combined consent (both interventions).
Control group
Active

Outcomes
Primary outcome [1] 326757 0
Factor one (concurrent/delayed consent): The primary outcomes will be the proportion of children for whom consent to any data linkage was shown on the consent form. This will be assessed from the consent forms that are returned.
Timepoint [1] 326757 0
Once all consent forms have been administered, and sufficient time given for these to be returned (3 months).
Primary outcome [2] 326758 0
Factor two (separate/combined consent): The primary outcome will be the proportion of children for whom consent to linkage of both health and education data were shown on the consent form. This will be assessed from the consent forms that are returned.
Timepoint [2] 326758 0
Once all consent forms have been administered, and sufficient time given for these to be returned (3 months).
Secondary outcome [1] 392588 0
The proportion of children for whom consent to linkage of health data was shown on the consent form. This will be assessed from the consent forms that are returned.
Timepoint [1] 392588 0
Once all consent forms have been administered, and sufficient time given for these to be returned (3 months).
Secondary outcome [2] 392589 0
The proportion of children for whom consent to linkage of education data was shown on the consent form. This will be assessed from the consent forms that are returned.
Timepoint [2] 392589 0
Once all consent forms have been administered, and sufficient time given for these to be returned (3 months).
Secondary outcome [3] 393994 0
The proportion of children for whom consent to in-person assessment but not data linkage was shown on the consent form. This will be assessed from the consent forms that are returned.
Timepoint [3] 393994 0
Once all consent forms have been administered, and sufficient time given for these to be returned (3 months).
Secondary outcome [4] 393995 0
The proportion of children for whom consent to data linkage but not in-person assessment was shown on the consent form. This will be assessed from the consent forms that are returned.
Timepoint [4] 393995 0
Once all consent forms have been administered, and sufficient time given for these to be returned (3 months).

Eligibility
Key inclusion criteria
Parents of all surviving children who took part in the pre-hPOD, hPOD or ProViDe trials in New Zealand and who are able to be contacted to seek consent for the NIEOS study (Neonatal Nutritional Interventions Early School-age Outcomes Studies). The NIEOS study is a follow-up study of children who participated in pre-hPOD, hPOD or ProViDe trials and are being assessed at school age (6-7 years corrected for preterm birth) for neurocognitive function, health and wellbeing, and cardiometabolic function.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who have previously withdrawn or refused consent for contact for follow-up, whose child has died, or who are outside New Zealand at the time of follow-up.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. However, central randomisation was conducted by computer. Due to the nature of this trial, allocation cannot be concealed from the research team (study co-ordinators) who will be recruiting participants. Study co-ordinators will be aware of the participant’s allocation but cannot change the allocation as the form will be pre-loaded on the child’s REDCap record at the time of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are randomised by simple computer-generated allocation sequence, stratified by the clinical trial in which the child originally participated (pre-hPOD, hPOD or ProViDe). The appropriate form is attached to the child’s REDCap record before the first invitation to participate in the in-person follow-up is sent, so that the appropriate information and consent forms are sent according to the assigned schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
This is a single-blind trial. Parents/caregivers will be unaware of the intervention as they are unaware of the trial. It is not possible to blind members of the research team (study co-ordinators) as they will be discussing the study information with parents/caregivers as part of the informed consent process. Analysis will be performed by researchers unaware of group designation. Emergency unbinding will not be needed in this study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data are categorical and will be presented as number (n) and percent (%). Factors will be compared using general linear models with exposure effects presented as OR and 95% CI, accounting for clustering within study and within the same pregnancy. The influence of ethnicity, socio-economic status, preterm birth and primary neonatal trial on consent rates will be assessed by tests of interaction with each factor.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
1/07/2021
Date of last participant enrolment
Anticipated
1/12/2027
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
2110
Accrual to date
1269
Final
Recruitment outside Australia
Country [1] 23516 0
New Zealand
State/province [1] 23516 0

Funding & Sponsors
Funding source category [1] 308043 0
Government body
Name [1] 308043 0
Health Research Council of New Zealand
Country [1] 308043 0
New Zealand
Primary sponsor type
University
Name
Liggins Institute, The University of Auckland
Address
Liggins Institute, The University of Auckland
85 Park Road
Grafton, Auckland 1023
New Zealand
Private Bag 92019
Country
New Zealand
Secondary sponsor category [1] 308770 0
None
Name [1] 308770 0
Address [1] 308770 0
Country [1] 308770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308035 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 308035 0
Ethics committee country [1] 308035 0
New Zealand
Date submitted for ethics approval [1] 308035 0
01/11/2019
Approval date [1] 308035 0
10/12/2019
Ethics approval number [1] 308035 0
19/STH/202Am01

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

Contacts
Principal investigator
Name 109290 0
Prof Jane Harding
Address 109290 0
Liggins Institute, The University of Auckland
85 Park Road
Grafton, Auckland 1023
New Zealand
Private Bag 92019
Country 109290 0
New Zealand
Phone 109290 0
+64 9 923 6439
Fax 109290 0
Email 109290 0
[email protected]
Contact person for public queries
Name 109291 0
Jane Harding
Address 109291 0
Liggins Institute, The University of Auckland
85 Park Road
Grafton, Auckland 1023
New Zealand
Private Bag 92019
Country 109291 0
New Zealand
Phone 109291 0
+64 9 923 6439
Fax 109291 0
Email 109291 0
[email protected]
Contact person for scientific queries
Name 109292 0
Jane Harding
Address 109292 0
Liggins Institute, The University of Auckland
85 Park Road
Grafton, Auckland 1023
New Zealand
Private Bag 92019
Country 109292 0
New Zealand
Phone 109292 0
+64 9 923 6439
Fax 109292 0
Email 109292 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 study dataset
When will data be available (start and end dates)?
Start date after publication of the main trial data. No anticipated end date.
Available to whom?
Data will be shared with researchers who provide a methodologically sound proposal and have appropriate ethical approval, where necessary, to achieve the research aims in the proposal, as approved by the Data Access Committee, Liggins Institute.
Available for what types of analyses?
Data will be shared with researchers who provide a methodologically sound proposal and have appropriate ethical approval, where necessary, to achieve the research aims in the proposal, as approved by the Data Access Committee, Liggins Institute.
How or where can data be obtained?
Data requestors can apply to the Liggins Data Access Committee, Liggins Institute ([email protected]). They are required to sign a Data Access Agreement that includes a commitment to using the data only for the specified proposal. Data will be made available electronically by a mechanism agreed with the researcher.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10914Study protocolTo be published  
10915Informed consent form    These will be available online via the institution... [More Details]
10916Clinical study report    These will be available online via the institution... [More Details]
10917Ethical approval    These will be available online via the institution... [More Details]
11376Other    These will be available online via the institution... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDifferent A pproaches to requesting Co nsent for R outine data linkage in N eonatal follow-up (ACORN): protocol for a 2x2 factorial randomised trial.2022https://dx.doi.org/10.1136/bmjopen-2021-060476
N.B. These documents automatically identified may not have been verified by the study sponsor.