Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001360808
Ethics application status
Approved
Date submitted
6/08/2021
Date registered
8/10/2021
Date last updated
8/10/2021
Date data sharing statement initially provided
8/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the Cost-Effectiveness of An Early Intervention Program for Eating Disorders In a Primary Health Care Setting
Scientific title
Health Economics Evaluation of emergED – an Early Intervention Strategy for Adolescents with Eating Disorders
Secondary ID [1] 304799 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 322865 0
Condition category
Condition code
Mental Health 320445 320445 0 0
Eating disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The research aims are to conduct an economic evaluation of an early intervention strategy for eating disorders(emergED) in a real-world setting, currently being delivered across two headspace locations in South Australia. Clients receiving services from emergED receive Cognitive Behavioural Therapy or psychoeducation depending on the severity of the eating problems, which is delivered by two Clinical Psychologists with expertise in eating disorders. Our study is evaluating the cost-effectiveness of this early intervention program as part routine service provision.
The aim of the economic evaluation is to test whether engagement in an early intervention eating disorder program can improve health outcomes and reduce the use of healthcare resources. Participants will be clients who are referred by GPs or self-referred to headspace for specialised eating disorder services. These participants will then be approached with all recruitment materials (information sheet, consent form and withdrawal of consent) and asked whether they would like to take part in this study. We intend to recruit roughly 100 participants aged 17-25, who are engaging in emergED services from July 2020 to end of March 2022.

Method: We will be requesting participants' consent to the release of the Medicare Benefit Scheme (MBS) and Pharmaceutical Benefit Scheme (PBS) data from July 2019 to September 2022. This will allow us to examine participants use of health resources 12-months prior to engagement with the services, and 6-months after their last treatment session. All eligible clients engaging in emergED services from July 2020 to March 2022 will be recruited to participate in this research project.

Participation in this study is completely voluntary and there will be no cost to participants. If participants do not want to take part in this study, they do not have to. Choosing not to take part in this study will not affect their current and future medical care in any way and will not impact on the provision of the emergED intervention.

As part of routine service provision, participants will complete the ED-15 questionnaire on a session-by-session basis, which surveys eating disorder cognitions and behaviours. Participants also complete the EQ-5D at intake, discharge, 1- and 3-month follow ups. Both questionnaires measures take approximately 15 minutes to complete. Participants complete these questionnaires online, in-session using the clinics' tablets and Wi-fi network. The results of these questionnaires will be obtained by accessing patient medical records.
Intervention code [1] 321172 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328280 0
Medicare Benefits Scheme data to allow total cost of treatment to be assessed using cost of doctor visits, hospitalisations etc.
Timepoint [1] 328280 0
12 months prior to engagement in emergED services and 6 months after engagement in emergED services. We will be asking for MBS data release from July 2019 to September 2022 in order to cover these time periods.
Primary outcome [2] 328910 0
Pharmaceutical Benefits Scheme Data to allow total cost of treatment to be assessed using cost of number of prescription medications filled out at pharmacies.
Timepoint [2] 328910 0
12 months prior to engagement in emergED services and 6 months after engagement in emergED services. We will be asking for PBS data release from July 2019 to September 2022 in order to cover these time periods.
Secondary outcome [1] 398343 0
Eating disorder behaviours and cognitions measured by the ED-15 (Tatham et al., 2015)
Timepoint [1] 398343 0
Assessed at the beginning of each treatment session for the duration of engagement in emergED services.
Secondary outcome [2] 398345 0
Health related Quality of Life (EQ-5D)
Timepoint [2] 398345 0
Measured at intake (when first engaged with emergED services), end of treatment, and 1-month post-treatment completion and 3-month post-treatment completion.

Eligibility
Key inclusion criteria
In order to be eligible for emergED services, participants have to be aged 16-25, display eating disorder symptoms for no longer than three years and have a BMI greater than 14.5.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded if they have a severe physical and/or psychiatric condition that would interfere with treatment (e.g. psychosis), if they are already receiving psychotherapy for an eating disorder, if they have difficulty speaking or understanding English,

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Calculations of sample size were based on the average number of clients seeking services from emergED. In the timeframe for this project, which will be including clients receiving services from July 2020 to end of March 2022, it is anticipated that a minimum sample size of 100 participants will be recruited. Thus, we will not be conducting a full health economics analysis as the small sample size will not provide us with enough power.

All analyses of secondary outcomes relating to eating disorder cognitions and behaviours will be conducted using IBM SPSS and R statistical software package. Given the session measures is not completed by participants on a weekly basis (due to missed appointments etc.) Multilevel Modelling will be conducted to analyses change over time.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/05/2021
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
30/10/2022
Actual
Sample size
Target
100
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 34880 0
5165 - Christies Beach
Recruitment postcode(s) [2] 34881 0
5113 - Davoren Park

Funding & Sponsors
Funding source category [1] 309170 0
University
Name [1] 309170 0
Flinders University, South Australia
Country [1] 309170 0
Australia
Primary sponsor type
University
Name
Flinders University, College of Education, Psychology and Social Work
Address
Flinders University, Sturt Rd, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 310129 0
None
Name [1] 310129 0
Address [1] 310129 0
Country [1] 310129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309032 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 309032 0
Ethics committee country [1] 309032 0
Australia
Date submitted for ethics approval [1] 309032 0
20/08/2020
Approval date [1] 309032 0
03/05/2021
Ethics approval number [1] 309032 0
205.20

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

Contacts
Principal investigator
Name 112718 0
Miss Marcela Radunz
Address 112718 0
Flinders University, School of Psychology
College of Education, Psychology and Social Work
Level 3, Room 349
Social Sciences North Building
Bedford Park, SA 5042
Country 112718 0
Australia
Phone 112718 0
+61 8 82015970
Fax 112718 0
Email 112718 0
[email protected]
Contact person for public queries
Name 112719 0
Marcela Radunz
Address 112719 0
Flinders University, School of Psychology
College of Education, Psychology and Social Work
Level 3, Room 349
Social Sciences North Building
Bedford Park, SA 5042
Country 112719 0
Australia
Phone 112719 0
+61 8 82015970
Fax 112719 0
Email 112719 0
[email protected]
Contact person for scientific queries
Name 112720 0
Marcela Radunz
Address 112720 0
Flinders University, School of Psychology
College of Education, Psychology and Social Work
Level 3, Room 349
Social Sciences North Building
Bedford Park, SA 5042
Country 112720 0
Australia
Phone 112720 0
+61 8 82015970
Fax 112720 0
Email 112720 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?
Data relating to eating disorder outcomes (ED-15) and EQ-5D will be made available upon request for meta-analytic purposes.
When will data be available (start and end dates)?
Data will not be available in data dictionaries. Data for this study (e.g. ED-15 outcome data for participants throughout the course of their emergED treatment) will only be available upon reasonable request to the author. This will be available from Mid 2023 onwards, and will be made available for 5 years.
Available to whom?
Available for eating disorder meta-analytic researchers.
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Data will be provided via email in SPSS de-identified file when reasonable requests for meta-analytic purposes is made to the key investigator in this project. Data will be available upon reasonable request to the author via email ([email protected]).


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.