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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12624001422516
Ethics application status
Approved
Date submitted
6/11/2024
Date registered
4/12/2024
Date last updated
27/04/2025
Date data sharing statement initially provided
4/12/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
REAFFIRM: a Regional tEletrial Assessing Feasibility oF clinical educatIon + Reinforcement for Menopause care
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Scientific title
a Regional tEletrial Assessing Feasibility oF clinical educatIon + Reinforcement for Menopause care in clinicians and patients
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Secondary ID [1]
313320
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None
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Universal Trial Number (UTN)
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Trial acronym
REAFFIRM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peri-menopause
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Menopause
335675
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Condition category
Condition code
Public Health
332237
332237
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0
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Health promotion/education
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Reproductive Health and Childbirth
332423
332423
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0
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Total study duration is approximately 18 months (3 month preparation, 6 months recruitment, 9 month intervention period for clinicians/patients, and 3 month final analysis & report,
Interventions for consenting participating clinicians:
- a 5-minute set of demographic questions plus question on whether there are any specific outcomes or positive impacts they are hoping to achieve as a result of study participation;
- a 5-minute set of VITAL registry-aligned questions including a) current age, b) if they were born with ovaries, c) ethnicity, d) their opinion on the level of knowledge for i) themselves, ii) the commuinity, iii) the workplace, and iv) the healthcare system, e) their sources of information about menopause, and voluntary question f) whether they have any additional interests in menopause beyond pure clinical practice;
- a 5-minute set of peri-/menopausal knowledge and confidence questions;
- approximately 3 months of standard practice conduct (control)
Approximately 3 months after initial clinician study consent:
- 4hr online Peri-/Menopause Foundations course, composed of 8 online education modules covering hormone biology, symptoms & course, diagnosis & possible treatments, with evidence-based information, videos and questions to self-test learnings included.
- a 5-minute review of three established internationally validated peri-/menopause questionnaires (Greene's Menopause Rating Scale, Meno-D, MenoQOL), plus study-specific patient peri-/menopause information resource brochure
- a 5-minute repeat set of peri-/menopausal knowledge and confidence questions,
For 9 months of intervention with participating clinicians implementing decision-support tools:
- a 10-15-minute set of peri-/menopause questionnaires (Greene's Menopause Rating Scale & Meno-D) for all relevant patients with the MenQOL added for eligible & consenting patients
- a 20-minute telehealth 3 month follow-up for ~5 eligible patients per participating clinician, including repeat implementation of questionnaires and request for patient feedback on study by clinician.
- a 10-minute repeat set of peri-/menopausal knowledge and comfort questions, plus opportunity for clinicians to provide feedback on individual intervention components plus general study feedback at the end of the study after 9 months of intervention.
- reference to additional established ongoing peri-/menopause education resources (menoECHO).
- ongoing clinician participant support & monitoring of study adherence by Bespoke Clinical Research, via fortnightly email communications during 1st month of each of control and intervention phases, review of study-specific data collected and participant-specific time windows, and additional contacts via multimedia (eg phone/virtual) as required, plus monthly study status updates throughout.
For relevant patients of participating clinicians during study participation:
- a 10-minute set of peri-/menopausal symptom questions via two established internationally validated questionnaires (Greene’s Menopause Rating Scale & Meno-D)
For eligible (symptomatic) consenting patients of participating clinicians:
- a 5-minute established internationally validated quality of life questionnaire in relation to peri-/menopause (MenQOL),
- a 5-minute set of demographic and medical history questions,
- a study-specific brochure to take home referencing established peri-/menopause information resources of different formats that offer varying communication styles to suit individual preferences (aural, written, virtual, in-person, questionnaire, app etcetera). For this feasibility study they include: Dear Menopause podcast, Healthy Hormones community forum, Menopause & Peri-Menopause Australia private Facebook group, Balance app, VITAL Peri-/Menopause research platform & registry, Sheela health advocacy, WellFemme webpage & online lifestyle program, Don't Sweat It insta posts/videos and in-person retreats, & Metluma additional menopause resource list.
- patient study adherence will be monitored by Bespoke Clinical Research in conjunction with their participating (treating) clinician, via review of study-specific data collected and participant-specific time windows, plus monthly study status updates.
- a 5-30-minute entry into the VITAL peri-/menopause at their convenience, and
- a 20-minute telehealth follow-up 3 months later including questionnaire repeat (symptoms and quality of life) and opportunity to offer study feedback.
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Intervention code [1]
329902
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Behaviour
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Intervention code [2]
329901
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Early detection / Screening
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Comparator / control treatment
Clinician participants shall be their own historical control via 3 months of standard clinical care (defined as unchanged clinical care, decision-making and judgement) after study consent, followed by 9 months of study-specified intervention. The switch from control to intervention will occur specific to each individual clinician as it will be prompted by completion of the clinician participant's Menopause Foundations education course, which will be conducted at approximately 3 months post-consent but at a time convenient to the individual clinician. Patient participants will be involved only in the intervention arm as part of the outcome learnings for clinician participants.
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Control group
Historical
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Outcomes
Primary outcome [1]
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Changes in self-assessed primary care clinicians' menopause-related knowledge and confidence in practice. This will be assessed as a composite outcome.
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Assessment method [1]
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As assessed via the validated Kirkpatrick Model of Evaluation. https://www.kirkpatrickpartners.com/the-kirkpatrick-model/ (accessed on 20.07.2024)
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Timepoint [1]
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End of study (9 months post-intervention commencement).
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Secondary outcome [1]
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Change in self-assessed primary care clinicians' menopause-related awareness in practice.
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Assessment method [1]
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Kirkpatrick Model of Evaluation
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Timepoint [1]
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Baseline (study consent), Intervention initiation (3 months post-consent), End of Study (9 months post-intervention initiation).
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Secondary outcome [2]
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Impact of intervention on clinicians
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Assessment method [2]
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Kirkpatrick Evaluation Tool
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Timepoint [2]
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End of Study (9 months post-intervention initiation)
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Secondary outcome [3]
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Change in self-assessed primary care clinicians' menopause-related confidence in practice.
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Assessment method [3]
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Kirkpatrick Evaluation Tool
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Timepoint [3]
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Baseline (study consent), Intervention initiation (3 months post-consent), End of Study (9 months post-intervention initiation).
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Secondary outcome [4]
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Impact of intervention on patients
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Assessment method [4]
442147
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Kirkpatrick Evaluation Tool
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Timepoint [4]
442147
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3 month telehealth follow-up (per patient)
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Secondary outcome [5]
442143
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Intervention measure expectation achievement in clinicians
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Assessment method [5]
442143
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Kirkpatrick Evaluation Tool
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Timepoint [5]
442143
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Intervention initiation (3 months post-consent), End of Study (9 months post-intervention initiation).
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Secondary outcome [6]
442145
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Ranked increase of brochure informational resource uptake for Australian resources as compared to average pre-study.
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Assessment method [6]
442145
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Download numbers from appropriate sources: supportive digital platforms (Healthy Hormones community registrations, VITAL registry, Don't Sweat It retreats, WellFemme Next Phase program, MenoEcho registrations), podcast platforms (Dear Menopause), and websites (Don't Sweat It, WellFemme).
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Timepoint [6]
442145
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First clinician intervention initiation (3 months post-first consent), End of Study (9 months post-final intervention initiation).
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Secondary outcome [7]
441490
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Change in self-assessed primary care clinicians' menopause-related knowledge in practice.
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Assessment method [7]
441490
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Kirkpatrick Model of Evaluation
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Timepoint [7]
441490
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Baseline (study consent), Intervention initiation (3 months post-consent), End of Study (9 months post-intervention initiation).
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Secondary outcome [8]
442144
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Change in uptake of Australian brochure informational resources as compared to average pre-study. This will be assessed as a composite outcome.
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Assessment method [8]
442144
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Download numbers from appropriate sources: supportive digital platforms (Healthy Hormones community registrations, VITAL registry, Don't Sweat It retreats, WellFemme Next Phase program, MenoEcho registrations), podcast platforms (Dear Menopause), and websites (Don't Sweat It, WellFemme).
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Timepoint [8]
442144
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First clinician intervention initiation (3 months post-first consent), End of Study (9 months post-final intervention initiation).
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Eligibility
Key inclusion criteria
Clinicians:
• Qualified and registered for clinical practice in Australia, e.g. Australian Health Practitioner Regulation Agency (AHPRA) minimum of 5 years of practice
• Practice-based with general practice
• Willing to comply with all study procedures, whether self-assessments, patient evaluations via validated questionnaires, provision of study-specific menopause information resource brochure, or 3-month telehealth follow-up intervention.
• English-speaking
• Appropriate access .to technology for Healthy Hormones education and telehealth Follow-Up
• Intention to continue Australian clinical general practice at least 0.6FTE throughout study duration
• Agreement with the Practice to undertake the study
Patients:
• Willing and able to consent
• Willing and able to comply with relevant study procedures including answer/completion of validated study questionnaires, receipt of study-specific menopause information resource brochure, and 3 month telehealth follow-up intervention.
• English-speaking
• Appropriate access to technology for telehealth Follow-Up
• Intention to remain living in Australia throughout study duration
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Not meeting inclusion criteria
Less than 18 yrs old
Not capable of providing informed consent.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
27/02/2025
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Actual
27/02/2025
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Date of last participant enrolment
Anticipated
30/06/2026
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Actual
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Date of last data collection
Anticipated
30/09/2026
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Actual
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Sample size
Target
300
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Accrual to date
6
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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Bespoke Clinical Research
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Address [1]
317770
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Bespoke Clinical Research
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Address
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Country
Australia
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Secondary sponsor category [1]
320226
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None
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Name [1]
320226
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Address [1]
320226
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Country [1]
320226
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee K
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Ethics committee address [1]
316458
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https://bellberry.com.au/
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Ethics committee country [1]
316458
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Australia
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Date submitted for ethics approval [1]
316458
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29/11/2024
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Approval date [1]
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29/01/2025
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Ethics approval number [1]
316458
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2024-11-1609
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Summary
Brief summary
Fifty-one percent of our current Australian population were born with ovaries and 6 million are now aged 40 or over; ie. at or approaching perimenopause and menopause, but very few clinicians have actually received training or education regarding menopause and its care. This study to aims to determine if the simple intervention proposed (combining education, reinforcement and telehealth) is a feasible approach to raise menopausal-awareness & training of your average primary care clinician (& patients too). This is especially important in rural/remote areas where telehealth follow-up may be significantly easier and patients are unlikely to have the option, and/or much longer wait times, to see menopause-specialist GPs who tend to be metropolitan-based.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Erin Morton
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Address
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Bespoke Clinical Research, C/O Erin Morton, Parcel Locker 10308 60619, 262 Main Rd Blackwood SA 5051
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Country
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Australia
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Phone
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+61403157844
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
137951
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Erin Morton
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Address
137951
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Bespoke Clinical Research, C/O Erin Morton, Parcel Locker 10308 60619, 262 Main Rd Blackwood SA 5051
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Country
137951
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Australia
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Phone
137951
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+61403157844
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Fax
137951
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Email
137951
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[email protected]
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Contact person for scientific queries
Name
137952
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Erin Morton
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Address
137952
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Bespoke Clinical Research, C/O Erin Morton, Parcel Locker 10308 60619, 262 Main Rd Blackwood SA 5051
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Country
137952
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Australia
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Phone
137952
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+61403157844
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Fax
137952
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Email
137952
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Due to the broad range of geographical locations from which clinician participants will be recruited, IPD sharing would be too easily reidentifiable with minimal effort. The potential for reidentification could influence participant responses both on knowledge (clinicians) and symptoms/impact (patients). Participants will be able to request a copy of their own data however, and deidentified appropriately aggregated data, plus data dictionaries, will both be made publicly available.
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.
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