Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000240549
Ethics application status
Approved
Date submitted
29/01/2024
Date registered
11/03/2024
Date last updated
21/06/2024
Date data sharing statement initially provided
11/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Bendigo Family Study - A tri-generational study of rural families and their access to healthcare.
Scientific title
The Bendigo Family Study - A tri-generational survey study of 500 rural families exploring preparation for hospital care, preparation for hospital discharge, parenting skills, access to information, chronic disease management in rural communities and attitudes to changes in healthcare.
Secondary ID [1] 311428 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal depression 332716 0
Perinatal anxiety 332945 0
Condition category
Condition code
Reproductive Health and Childbirth 329429 329429 0 0
Childbirth and postnatal care
Mental Health 329660 329660 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Completion of study questionnaire. A questionnaire will be used to collect information directly from participants. Questionnaires include the following validated research tools:
• Hospital anxiety and depression scale
• Cyberchondria short scale-12
• Breastfeeding Self-Efficacy Scale-Short Form
• Brief Parental Self Efficacy Scale
• Long-Term Conditions Questionnaire
and questions specifically developed for this study. The questionnaires will take approximately 45 minutes to complete.. Data will also be audited from the pregnancy record. The time covered by collected data is from pregnancy to postnatal period (6 weeks).
Intervention code [1] 327873 0
Not applicable
Comparator / control treatment
Not applicable. Observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337250 0
Depression
Timepoint [1] 337250 0
Within 6 weeks of birth
Primary outcome [2] 337447 0
Anxiety
Timepoint [2] 337447 0
Within 6 weeks of birth
Secondary outcome [1] 431203 0
Parenting stress
Timepoint [1] 431203 0
Within 6 weeks of birth
Secondary outcome [2] 431886 0
Breastfeeding
Timepoint [2] 431886 0
Within 6 weeks of birth
Secondary outcome [3] 431887 0
Access information from the internet
Timepoint [3] 431887 0
Within 6 weeks of birth
Secondary outcome [4] 431888 0
Management of chronic disease in community
Timepoint [4] 431888 0
Within 6 weeks of birth
Secondary outcome [5] 431889 0
Attitudes to health innovation
Timepoint [5] 431889 0
Within 6 weeks of birth

Eligibility
Key inclusion criteria
Women who have delivered a baby (greater than 22 weeks) within the prior 7 days, their partner and a grandparent if applicable. Sufficient english to complete the questionnaire.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack sufficient english to complete questionnaire.
Birth before 22 weeks gestation.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2024
Actual
20/05/2024
Date of last participant enrolment
Anticipated
1/11/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
1500
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26123 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 41979 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 315702 0
Self funded/Unfunded
Name [1] 315702 0
Country [1] 315702 0
Primary sponsor type
Hospital
Name
Bendigo Health Service
Address
Country
Australia
Secondary sponsor category [1] 317806 0
University
Name [1] 317806 0
University of Notre Dame Australia
Address [1] 317806 0
Country [1] 317806 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314570 0
Bendigo Health Human Research Ethics Committee
Ethics committee address [1] 314570 0
Ethics committee country [1] 314570 0
Australia
Date submitted for ethics approval [1] 314570 0
24/01/2024
Approval date [1] 314570 0
24/04/2024
Ethics approval number [1] 314570 0
HREC/103372/BH-2024-417877(v3)
Ethics committee name [2] 314571 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [2] 314571 0
Ethics committee country [2] 314571 0
Australia
Date submitted for ethics approval [2] 314571 0
29/02/2024
Approval date [2] 314571 0
Ethics approval number [2] 314571 0

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

Contacts
Principal investigator
Name 132046 0
Prof Julie Quinlivan
Address 132046 0
Institute for Health Research University of Notre Dame Australia, 21 Henry St Fremantle Western Australia 6160
Country 132046 0
Australia
Phone 132046 0
+61 8 9433 0555
Fax 132046 0
Email 132046 0
[email protected]
Contact person for public queries
Name 132047 0
Julie Quinlivan
Address 132047 0
Institute for Health Research University of Notre Dame Australia, 21 Henry St Fremantle Western Australia 6160
Country 132047 0
Australia
Phone 132047 0
+61 8 9433 0555
Fax 132047 0
Email 132047 0
[email protected]
Contact person for scientific queries
Name 132048 0
Julie Quinlivan
Address 132048 0
Institute for Health Research University of Notre Dame Australia, 21 Henry St Fremantle Western Australia 6160
Country 132048 0
Australia
Phone 132048 0
+61 8 9433 0555
Fax 132048 0
Email 132048 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.