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Trial registered on ANZCTR


Registration number
ACTRN12621001651875
Ethics application status
Approved
Date submitted
9/11/2021
Date registered
1/12/2021
Date last updated
20/05/2024
Date data sharing statement initially provided
1/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical evaluation of the Wandi Nerida Residential care facility.
Scientific title
Clinical evaluation of the Wandi Nerida Residential care facility for multidisciplinary residential care for people with eating disorders and effect on eating disorder symptoms including body image perception, body mass index (BMI), general mental and physical health and co-morbidities, health-related quality of life (HRQoL), and role impairment.
Secondary ID [1] 305728 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Eating Disorder 324213 0
Anorexia nervosa 324214 0
Bulimia Nervosa 324215 0
Binge Eating Disorder 324216 0
Condition category
Condition code
Mental Health 321700 321700 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Residential program: Wandi Nerida is an intensive multidisciplinary (medical, psychological, nutritional and supportive with supervision of meals) program of care that has the unique feature of promoting person-centred and least restrictive care and a high level of lived experience informed therapy and health care providers for people with eating disorders. There are an anticipated 60-70 separations on an annual basis. Participants will have completed at least 4-weeks of the Wandi Nerida program, and most an 8-week program.
The Wandi Nerida program of care will be available as usual to those who do not participate in this study.
Health information and experiences at the facility will be collected via online surveys (around 30-40 minutes each time). Participants will be asked to complete (1) quantitative and qualitative psychometric measures at 5 different time points (pre-treatment, 4 weeks, 8 weeks, 3 months post-treatment, 6 months post-treatment) and (2) weekly symptoms via online survey (about 15 minutes) for each week they are at the program and (3). All will be invited to an additional interview of 30-60 minutes that comprises (1) completing a short structured interview to gather demographic, diagnostic and past treatment information and (2) participating in a semi-structured interview exploring their experiences of care.
Participant carer's will also be asked to complete quantitative and qualitative psychometric measures via online survey at 3 different time points (pre-treatment, 8 weeks/discharge, 3 months post-treatment): (1) at baseline online self-report questionnaires (taking about 30 minutes) assessing caregiver burden, distress, use of health services, quality of life, and and expectations for treatment; (2) at 8 weeks/discharge self-report questionnaire assessing treatment satisfaction and qualitative questions that relate to treatment experiences (about 20 minutes).; and (3) at 3-months post discharge quantitative self-report questionnaires (about 30 minutes) assessing caregiver burden, distress, and quality of life. Cares (about 10) also will also be invited to an indepth semi-structured interview (of 30-60 minutes) with particular interest in how the individual carer/parent/spouse experienced and ascribes meaning to their and their family’s experiences of the Wanda Nerida program.
Healthcare providers (up to 10) at Wandi Nerida residential program will be invited to a semi -structured interview of 30-60 minutes with particular interest in the health care provider’s experiences, perception and satisfaction with care during their time working at the Wandi Nerida program
Intervention code [1] 322288 0
Treatment: Other
Comparator / control treatment
For primary outcomes only an ongoing treatment survey at other facilities will be employed (TrEAT e.g., see Trompeter, et al. 2021. Differences between Australian adolescents with eating disorder symptoms who are in treatment or not in treatment for an eating disorder. Early Intervention in Psychiatry, 15(4), pp.882-888).
In particular, outcomes will be compared with people having usual care at the Queensland.Day program, an 8-week closed group program. There are 8 patients (6 patients until COVID physical distancing requirements end) at any one time, 4 days a week and 7.5-8 hours a day of supervised meals and therapy groups. We anticipate it will match to the Wandi Nerida program with respect to severity of illness experienced by participants and intensity of therapy and differs in the key element of provision of the residence and the lived experience care providers (currently 2 hours per program, i.e., many fewer hours than the Wandi Nerida program) and 25% meal supervision weekly versus 100% at Wandi Nerida. The estimated number of separations per year is around 30.
Health information and experiences at the facility will be collected via online surveys (around 30-40 minutes each time). Participants will be asked to complete (1) quantitative and qualitative psychometric measures at 5 different time points (pre-treatment, 4 weeks, 8 weeks, 3 months post-treatment, 6 months post-treatment) and (2) weekly symptoms via online survey (about 15 minutes) for each week they are at the program.

Control group
Active

Outcomes
Primary outcome [1] 329462 0
Eating disorder symptoms as measured on the Eating Disorder Examination Questionnaire : global score
Timepoint [1] 329462 0
End of treatment, 3 and 6 months post-end of treatment
Primary outcome [2] 329463 0
body mass index (BMI); kg/m2 assessed by clinician entered data from assessment with calibrated scales and stadiometer and reported via an online survey
Timepoint [2] 329463 0
End of treatment
Primary outcome [3] 329464 0
health-related quality of life (HRQoL) as measured on the EuroQoL Research Foundation scale
Timepoint [3] 329464 0
End of treatment, 3 and 6 months post-end of treatment
Secondary outcome [1] 402695 0
treatment attrition, - people who complete less than 4 weeks of the Wandi Nerida program; data collected by clinician report on online survey
Timepoint [1] 402695 0
end of treatment
Secondary outcome [2] 402696 0
impacts on health care - • A short survey will be administered. The timeframe of the last 2 months will be used to capture all healthcare use (consultations with health professionals, hospital admissions, medications, ambulance, NDIS support), and was deemed appropriate given concerns that a longer timeframe will suffer from poor recall. The survey will be specifically designed to capture utilisation that may be related to the intervention, and specify potentially irrelevant or random events such as appendicitis.
Timepoint [2] 402696 0
pre admission and 6-months follow-up from the Wandi Nerida program
Secondary outcome [3] 402697 0
role impariment - a standardized item taken from the Australian National Survey of Health and which asks respondents to indicate the number of days in the past 28 days they were unable to work or undertake their usual activities for reasons related to their health.
Timepoint [3] 402697 0
pre admission and 6-months follow-up from the Wandi Nerida program 6-month follow=up
Secondary outcome [4] 402698 0
client satisfaction with care from the Wandi Nerida program
Timepoint [4] 402698 0
end of treatment
Secondary outcome [5] 402699 0
carer satisfaction with care from the Wandi Nerida program
Timepoint [5] 402699 0
end of treatment
Secondary outcome [6] 402703 0
Depression as measured on the Patient Health Questionnaire (PHQ-9) – a 9-item valid and reliable self-report measure of depression severity, with ability to make criteria-based diagnoses for depression.
Timepoint [6] 402703 0
End of treatment, 3 and 6 months post-end of treatment
Secondary outcome [7] 402704 0
Anxiety as measured on the Generalised Anxiety Disorder Screener (GAD-7) – a 7-item self-report questionnaire for general anxiety over the past 2 weeks, the GAD-7 has been validated in numerous clinical and population samples and has cut-off scores for mild to severe anxiety.
Timepoint [7] 402704 0
End of treatment, 3 and 6 months .post-end of treatment

Eligibility
Key inclusion criteria
All people admitted to either program and consenting to participate in research assessments.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no specific exclusion criteria but participants will need to agree/consent and to have English literacy capacity to complete the research assessments.

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
In the study clinical cohorts of individuals receiving usual care in different treatment facilities are being compared prospectively on primary outcomes only.. There is no assignment to groups and no participant masking. . The analyses will be conducted by researchers blind to group membership.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Research persons based at WSU responsible for data management and analyses and will be blind to study group. SPSS, R or STATA for most statistics will be used. Baseline univariate between group tests will be executed to compare groups on outcome variables, clinical and demographic data. Data will be analysed following “intention-to-treat” principles. Generalised linear mixed effects modeling with a logit response function will be used for dichotomous outcomes to test for between group differences. Linear mixed effects modeling will be used to test for between group differences in the continuous outcome measures, namely levels of ED symptom change, adaptive function, quality of life, depression and anxiety levels, and BMI. Analyses will control for putative confounding variable (differences at baseline) as this is not a randomised trial. These analytic methods will also be used to test determinants of outcomes.
Qualitative Outcomes: Thematic analysis
The client, carer, and health care provider and referrer (e.g. RBWH Medical Ward; Psychiatric Emergency Centre RBWH; Mental Health Centre RBWH; QuEDS; Other Mental Health Units in Qld; Community private practitioners) interviews will explore peoples’ treatment experiences including those reported to underpin the philosophy of care of the B-FREEDT treatment intervention as informed by: (1) the RANZCP clinical practice guideline ; and (2) key tenets of the recovery model .
Qualitative data will be generated through semi-structured interviews that scaffold between person’s treatment experiences/perceptions and ways they ascribe meaning to these experiences and their identity shifts (see interview details p 12-13). Interviews will be audio-taped, transcribed and de-identified and data will be analysed through a thematic analysis with sensitised concepts drawn from the key areas of the recovery model (as cited in the B-FREEDT Model of care, such as symptom improvement, hope, recovery, identity shifts that include a reconnection with a sense of meaning and purpose). Identity shifts will also be analysed through discourse/discursive qualitative methods . Persons with a lived experience, their carers’ and treatment providers will be consulted to ensure that the analysis is valid, authentic, and resonates and aligns with their lived experience.
The numbers interviewed within each of the 4 groups of interviews is unknown, but is anticipated to be between 10 and 15 to reach saturation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/01/2022
Actual
1/03/2022
Date of last participant enrolment
Anticipated
Actual
23/10/2023
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
200
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21033 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 35872 0
4029 - Herston
Recruitment postcode(s) [2] 35873 0
4553 - Mooloolah Valley

Funding & Sponsors
Funding source category [1] 310086 0
Charities/Societies/Foundations
Name [1] 310086 0
Butterfly Foundation
Country [1] 310086 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith South
NSW 2051
Country
Australia
Secondary sponsor category [1] 311146 0
None
Name [1] 311146 0
Address [1] 311146 0
Country [1] 311146 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309776 0
Western Sydney University HREC
Ethics committee address [1] 309776 0
Locked Bag 1797 Penrith South 2751 NSW
Ethics committee country [1] 309776 0
Australia
Date submitted for ethics approval [1] 309776 0
24/11/2021
Approval date [1] 309776 0
17/02/2022
Ethics approval number [1] 309776 0
HREC14742
Ethics committee name [2] 309777 0
The Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC)
Ethics committee address [2] 309777 0
Human Research Ethics Office
Level 2, Building 34
Butterfield Street
HERSTON QLD 4029
Ethics committee country [2] 309777 0
Australia
Date submitted for ethics approval [2] 309777 0
02/07/2021
Approval date [2] 309777 0
22/02/2022
Ethics approval number [2] 309777 0
76879

Summary
Brief summary
The proposed study will comprise a 2-armed, 2-site, data-analytic blind clinical trial to determine the clinical effectiveness of the Wandi Nerida program. The data management site will be at the WSU Macarthur Clinical School. The recruitment and treatment sites will be at the Wandi Nerida program and the Royal Brisbane Hospital Day program.
The project will be informed by a co-design and Participatory Action Research (PAR) approach. Over a 24-month period we have been advised to anticipate 120 Wandi Nerida participant and 46 Day Program participant separations. Continued recruitment for an additional 6 months would ensure a minimum of 60 participants per group. This estimate this will allow for a mean difference medium effect size of .5 for eating disorder symptoms severity or other continuous outcomes using Cohen’s table. The number who do not engage with and/or do not complete (leave within 4 weeks of treatment) at the Wandi Nerida program is unknown at this stage.The data set for the Clinical Evaluation will include but is not limited to measures on: eating disorder diagnosis prior to residential treatment; body mass index; psychopathology; ability to complete daily activities; related mental health and wellbeing scores (comorbidities); and QALY estimates. The research will extend upon the minimum data set developed by the Federal Technical Advisory Group (TAG) to also include measures that assess outcomes related to (1) the unique aspects of the B-FREEDT model of care through qualitative exploration, (2) the testing of key indicators for measuring change, (3) changes in concurrent and ongoing healthcare utilisation, (4) stakeholders other than the clients themselves and extending to family members and clinicians inside and external to Wandi Nerida, and (4) the monitoring of clinical outcomes of clients and their families over six months from start of treatment. Notably only the data pertaining to primary outcomes will be collected a the control site.
Trial website
Trial related presentations / publications
Public notes
Data for the primary outcomes will be sourced from the TrEAT survey, which has HREC approval from Western Sydney University HREC.
Project Title "Clinical and demographic correlates of eating disorder treatment seekers" WSU HREC project number H14478 approval period 7 June 2021 until 7 June 2026.
The Wandi Nerida program has been approved as a site for the TrEAT survey. on Aug 26 2021. An application to the RBH HREC (HREC/2021/QRBW/76879 Approved - awaiting Site Specific approval) and subsequently to WSU HREC to add the Queensland Day Program as a site to TrEAT is in progress.

Contacts
Principal investigator
Name 115350 0
Prof Phillipa Hay
Address 115350 0
Macarthur Clinical School
Locked Bag 1797
Penrith South 2751 NSW
Country 115350 0
Australia
Phone 115350 0
+61417168077
Fax 115350 0
Email 115350 0
[email protected]
Contact person for public queries
Name 115351 0
Phillipa Hay
Address 115351 0
Macarthur Clinical School
Locked Bag 1797
Penrith South 2751 NSW
Country 115351 0
Australia
Phone 115351 0
+61417168077
Fax 115351 0
Email 115351 0
[email protected]
Contact person for scientific queries
Name 115352 0
Phillipa Hay
Address 115352 0
Macarthur Clinical School
Locked Bag 1797
Penrith South 2751 NSW
Country 115352 0
Australia
Phone 115352 0
+61417168077
Fax 115352 0
Email 115352 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?
De-identified demographic and clinical status quantitative clinical state data only to approved investigators and with consent of participants.
When will data be available (start and end dates)?
Post initial publication; no end date determined.
Available to whom?
Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator and WSU HREC via secure passwored protected files and Cloudstor or other web based mechanism.
Contact the principal investigator, [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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