Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000835549
Ethics application status
Approved
Date submitted
11/06/2024
Date registered
5/07/2024
Date last updated
19/10/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a co-designed shared care model of care on the quality of life of patients accessing gender affirming hormone therapy
Scientific title
Evaluating a co-designed shared care model of care on the quality of life of patients accessing gender affirming hormone therapy
Secondary ID [1] 312321 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COSMAT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gender Dysphoria 334075 0
Condition category
Condition code
Mental Health 330750 330750 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The shared care model of care co-design process was completed in 2023 with input from trans community members, GPs, practice manager, rural trans community organisations and primary care health networks in rural Victoria.

Current standard of care involves being on a waiting list for 9 months to access specialised gender clinics in Melbourne where initiation and monitoring of hormone therapy is provided by the specialist gender clinic without expectation of the GP to provide significant input. Patients often travel long distances to access care from rural Victoria to metropolitan Melbourne Victoria.

The intervention will be the shared care model of care. The shared care model of care will be available to patients living in rural Victoria (Modified Monash Model Remoteness Areas 2 - 7). It will actively involve their local rural GP alternating consultations with the specialist gender clinic whilst the local rural GP concurrently is supported with an existing training course in gender affirming care (run by Thorne Harbour Health), existing training resources (AusPATH informed consent standards of care, HealthPathways, Transhub website) and the specialist gender clinic endocrinologist. Patients will be supported by a peer navigator and also connected to local rural trans organisations if available in the patient's location of residence. Clinic visits will be one-on-one and occur 3 monthly for 24 months but alternate between the specialist gender clinic endocrinologist via telehealth and the local rural GP face-to-face, The frequency of clinic visits with specialist gender clinic endocrinologist gradually decreases whilst clinic visits with the local rural GP gradually increases over the 24 month period. The shared care model of care will be facilitated by a specialist gender care nurse and adherence by the GP and patient will be supported by session attendance checklists. Both patients and their GPs will provide consent to participate in the shared care model of care.
Intervention code [1] 328795 0
Treatment: Other
Comparator / control treatment
The comparator will be standard care at existing Austin Health Gender Clinic in Heidelberg, Victoria or Equinox Gender Diverse Health Centre, Abbotsford, Victoria. Current standard of care involves being on a waiting list for 9 months to access specialised gender clinics in Melbourne (face-to-face or telehealth depending on patient preference) where initiation and monitoring of hormone therapy is provided by the specialist gender clinic without expectation of the local GP to provide significant input. Peer support is available to patients if requested. Patients often travel long distances to access care from rural Victoria to metropolitan Melbourne Victoria.
Control group
Active

Outcomes
Primary outcome [1] 338511 0
Quality of life
Timepoint [1] 338511 0
0, 3, 6 (primary timepoint), 12, 24 months post-enrolment
Primary outcome [2] 338666 0
Quality of life
Timepoint [2] 338666 0
0, 3, 6 (primary timepoint), 12, 24 months post-enrolment
Primary outcome [3] 338669 0
GP knowledge and GP confidence in transgender health
Timepoint [3] 338669 0
0, 12 (primary timepoint), 24 months post-enrolment
Secondary outcome [1] 436219 0
Depression
Timepoint [1] 436219 0
0, 3, 6, 12, 24 months post-enrolment
Secondary outcome [2] 436220 0
Suicidal ideation
Timepoint [2] 436220 0
0, 3, 6, 12, 24 months post-enrolment
Secondary outcome [3] 436221 0
Gender Dysphoria
Timepoint [3] 436221 0
0, 3, 6, 12, 24 months post-enrolment
Secondary outcome [4] 436222 0
Patient Satisfaction
Timepoint [4] 436222 0
0, 3, 6, 12, 24 months post-enrolment
Secondary outcome [5] 436223 0
Health service utilisation for cost effectiveness analysis
Timepoint [5] 436223 0
0, 3, 6, 12, 24 months post-enrolment

Eligibility
Key inclusion criteria
1. Currently residing in rural or remote Victoria (Modified Monash Model Remoteness Areas 2 – 7)
2. Aged 18 years or over
3. Aged 16 – 17 and have both parents provide informed consent for the initiation of gender affirming hormone therapy and participation.
4. Have a gender that is different from what was recorded at birth (i.e. transgender or gender diverse), including binary and non-binary gender identities, or cultural gender identities
5. Have been referred to a Gender Clinic for commencement of gender affirming hormone therapy
6. Have capacity to provide informed consent
7. Able to understand and complete questionnaires
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- aged under 16 years
- have a gender that is congruent with what was presumed for them at birth (i.e. cisgender)

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2024
Actual
Date of last participant enrolment
Anticipated
2/09/2027
Actual
Date of last data collection
Anticipated
2/09/2029
Actual
Sample size
Target
234
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26675 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 42715 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 316716 0
Government body
Name [1] 316716 0
Australian Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 316716 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318922 0
None
Name [1] 318922 0
Address [1] 318922 0
Country [1] 318922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315492 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 315492 0
Ethics committee country [1] 315492 0
Australia
Date submitted for ethics approval [1] 315492 0
11/06/2024
Approval date [1] 315492 0
12/08/2024
Ethics approval number [1] 315492 0
HREC/106019/Austin-2024

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

Contacts
Principal investigator
Name 134866 0
A/Prof Ada Cheung
Address 134866 0
Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 134866 0
Australia
Phone 134866 0
+61 3 94965489
Fax 134866 0
Email 134866 0
[email protected]
Contact person for public queries
Name 134867 0
Ada Cheung
Address 134867 0
Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 134867 0
Australia
Phone 134867 0
+61 3 94965489
Fax 134867 0
Email 134867 0
[email protected]
Contact person for scientific queries
Name 134868 0
Ada Cheung
Address 134868 0
Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 134868 0
Australia
Phone 134868 0
+61 3 94965489
Fax 134868 0
Email 134868 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.