Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000412639p
Ethics application status
Submitted, not yet approved
Date submitted
25/10/2022
Date registered
26/04/2023
Date last updated
26/04/2023
Date data sharing statement initially provided
26/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Shared Decision Making in Pregnancy in Inflammatory Bowel Disease: Validation of a Decision Aid for Pregnancy in Inflammatory Bowel Disease
Scientific title
Shared Decision Making in Pregnancy in Inflammatory Bowel Disease: Validation of a Decision Aid to Assist Patients and their Health Care Team make informed decisions regarding the Management of IBD during Pregnancy and Peripartum
Secondary ID [1] 308246 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 328044 0
Condition category
Condition code
Oral and Gastrointestinal 325100 325100 0 0
Inflammatory bowel disease
Reproductive Health and Childbirth 325218 325218 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 326295 326295 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Delivery of a web based decision aid relating to pregnancy related issues in inflammatory bowel disease (IBD) 1 week prior to the consultation with their usual gastroenterologist.
Web based education tool (approximately 10 minutes anticipated to complete) that allows users to input their condition and circumstances to generate information relevant to them in relation to fertility and pregnancy in the context of inflammatory bowel disease.

Target population: Preconception patients

The first half of the study will allocate all patients to the control arm and the subsequent half of the study (once 60 controls recruited), to the interventional arm. This is aimed as preventing any influence of the decision aid on the treating gastroenterologist and their interactions with participants from the control arm.

No specific measure to monitor adherence - self reported only.

Intervention code [1] 324720 0
Prevention
Comparator / control treatment
Standard of care - patients will attend their scheduled gastroenterology appointments which may or may not involve discussion regarding reproductive and pregnancy related issues in IBD.
Control group
Active

Outcomes
Primary outcome [1] 332919 0
Change in the quality of the decision-making process as measured score in the Decisional Conflict Scale will be the primary outcome variable.
Timepoint [1] 332919 0
Timepoint 1 - Baseline (pre-intervention)
Timepoint 2 - 2 weeks following consultation
Timepoint 3 - 2 months following consultation
Secondary outcome [1] 415687 0
Preparation for Decision Making (PrepDM) scale
Timepoint [1] 415687 0
Timepoint 1 - Baseline (pre-intervention)
Timepoint 2 - 2 weeks following consultation
Timepoint 3 - 2 months following consultation
Secondary outcome [2] 415688 0
Crohn’s & Colitis Pregnancy Knowledge Score (CPPKnow)
Timepoint [2] 415688 0
Timepoint 1 - Baseline (pre-intervention)
Timepoint 2 - 2 weeks following consultation
Timepoint 3 - 2 months following consultation
Secondary outcome [3] 415689 0
Satisfaction with Decision Scale (SWD)
Timepoint [3] 415689 0
Timepoint 1 - Baseline (pre-intervention)
Timepoint 2 - 2 weeks following consultation
Timepoint 3 - 2 months following consultation

Eligibility
Key inclusion criteria
Female gender
18 to 45 years of age (reproductive age group)
Confirmed diagnosis of ulcerative colitis, Crohn’s disease or IBD-indeterminate
Preconception
Interest in considering issues surrounding pregnancy
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Post partum (within 6 months)
Inability to speak or read English sufficiently to complete surveys or use decision aid

Study design
Purpose of the study
Educational / counselling / training
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
Participants in the first half of the study (first 6 months) - will ALL be enrolled into non-intervention arm (e.g. standard consultation only).
Participants in the second half of the study (second 6 months) will ALL be enrolled into the intervention (decision aid + standard consultation) arm.

This will prevent bias of the treating clinician from being incidentally exposed to patients who have and haven't received the decision aid (and hence altering their clinical practice).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/05/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 25081 0
Canada
State/province [1] 25081 0
Ontario

Funding & Sponsors
Funding source category [1] 312503 0
Self funded/Unfunded
Name [1] 312503 0
None
Country [1] 312503 0
Primary sponsor type
Government body
Name
Sydney South West Local Health District (SWSLHD)
Address
Administration Building, Eastern Campus, Liverpool Hospital Locked Bag 7279, Liverpool BC 1871
Country
Australia
Secondary sponsor category [1] 314795 0
None
Name [1] 314795 0
None
Address [1] 314795 0
None
Country [1] 314795 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311839 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 311839 0
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Scrivener Street
LIVERPOOL NSW 2170
Ethics committee country [1] 311839 0
Australia
Date submitted for ethics approval [1] 311839 0
25/10/2022
Approval date [1] 311839 0
Ethics approval number [1] 311839 0

Summary
Brief summary
This is a multicentre non-randomized clinical trial looking to examine the benefit of implementing a decision aid named Pregnancy IBD Decision Aid (PIDA). Access to dedicated pre-conception counselling sessions within both metropolitan, regional and rural Australia and Canada however can be limited, given the restricted number of specialised ‘pregnancy in IBD’ clinics. A decision aid, to be utilised in conjunction with outpatient clinical appointments, may provide a method by which to overcome such limitations in access.

Each site will have study outcomes collected over a six month period during the implementation of the current standard of care of preconception counselling; in the following six months the intervention (PIDA) will precede this standard of care. Sites will comprise a combination of tertiary centres with dedicated pregnancy in IBD Clinics, in addition to non-tertiary centres which provide non-specialised IBD care.

An improvement in the quality of the decision-making process as measured by the Decisional Conflict Scale will be the primary outcome variable. The secondary outcome variables are:
1. Quality of decision-making process (as assessed by PrepDM scale questionnaire)
2. Quality of decision comprising knowledge and congruence of values (as assessed by CCPKnow; SWD questionnaires)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122550 0
Dr Patrick Chan
Address 122550 0
Clinic 123, Level 1, Liverpool Hospital, Elizabeth St, Liverpool, NSW, 2170
Country 122550 0
Australia
Phone 122550 0
+61 287384085
Fax 122550 0
Email 122550 0
[email protected]
Contact person for public queries
Name 122551 0
Patrick Chan
Address 122551 0
Clinic 123, Level 1, Liverpool Hospital, Elizabeth St, Liverpool, NSW, 2170
Country 122551 0
Australia
Phone 122551 0
+61 287384085
Fax 122551 0
Email 122551 0
[email protected]
Contact person for scientific queries
Name 122552 0
Patrick Chan
Address 122552 0
Clinic 123, Level 1, Liverpool Hospital, Elizabeth St, Liverpool, NSW, 2170
Country 122552 0
Australia
Phone 122552 0
+61 287384085
Fax 122552 0
Email 122552 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.