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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623001258640
Ethics application status
Approved
Date submitted
25/09/2023
Date registered
5/12/2023
Date last updated
5/12/2023
Date data sharing statement initially provided
5/12/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Lily: Eating Disorder Clinical Registry
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Scientific title
The Lily: Eating Disorder Clinical Registry
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Secondary ID [1]
310366
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Medically unstable eating disorders
331105
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Condition category
Condition code
Mental Health
327892
327892
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0
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Eating disorders
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Emergency medicine
328296
328296
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0
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Other emergency care
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
3
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Target follow-up type
Months
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Description of intervention(s) / exposure
The Lily Registry will include all patients with eating disorders identified as medically unstable upon admission to the emergency department of a hospital, and if the instability is secondary to the eating disorder. These patients will be given the option to ‘opt-out’ of ongoing data collection in the Registry for their current hospital admission, once they are deemed stable by the attending clinical team. Participation is presumed unless the patient takes action to decline to participate. Data regarding the patient’s condition, cognitive-behavioural changes and general care will be obtained by the treating medical staff including attending physicians, nurses, dietitians, psychiatrists, paediatricians (if applicable), or authorised delegees. There is also an ‘opt-in’ component of the project that requires self-reporting by the patient. These questionnaires will be made available to the patient via an email link which can be accessed on a tablet, computer, or mobile phone. Those who consented to the opt-in componenet of the study will receive questionnaires at regular intervals after discharge at 3, 6 and 12 months. All participants will be closely followed up by a team at outpatient clinics, community dieticians or readmission to hospital as part of their standard course of treatment and is not related to the project itself.
Patient-identifiable information in the Registry is only visible to the treating clinical team. Data can be de-identified or re-identified based on role permissions granted to registry personnel. The collected data will be encrypted and securely stored. Thus, The Lily Registry will act as a platform to improve service quality for this very vulnerable group of patients, with the resultant learning and clinical research opportunities for clinicians and trainees. This registry will include both adult and paediatric patients. There is no defined duration or endpoint for the Registy. According to the ASCQHC National Framework for Clinical Quality Registries consultation paper, “CQRs shall support the retention of active records over 20 year periods to support longitudinal data analysis. After 20 years, records will be archived, but still be available for analysis."
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Intervention code [1]
327043
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Not applicable
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Comparator / control treatment
None.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility of 100% patient data entry (validated against administrative data using ICD-10 codes). That is, every patient considered medically unstable due to an eating disorder will be enrolled.
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Assessment method [1]
336123
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Timepoint [1]
336123
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This outcome will be assessed every 12 months (at a minimum) post study commencement.
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Secondary outcome [1]
426913
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Time to haemodynamic stability: the time taken to achieve vital signs that no longer meet admission criteria. For example, no significant postural change in blood pressure or heart rate and resting heart rate >40 beats per minute. As this is an observational study, we will be collecting retrospective data. This means that the research team (who are also part of the clinical team) at respective sites will be obtaining data (i.e. change in blood pressure, heart rate, laboratory results, multi disciplinary meeting notes etc.) from Electronic Medical Records (EMR) as eligible patients who have consented are enrolled in this registry study.
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Assessment method [1]
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Timepoint [1]
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This outcome will be assessed every 12 months (at a minimum or as needed) post study commencement.
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Secondary outcome [2]
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Baseline changes in scores from the symptom inventory, ED-15.
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Assessment method [2]
428573
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Timepoint [2]
428573
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Every 12 months (at a minimum or as needed) post study commencement.
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Secondary outcome [3]
429032
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Time to biochemical stability: defined as no significant abnormality for two consecutive days, demonstrated on the third day. As this is an observational study, we will be collecting retrospective data. This means that the research team (who are also part of the clinical team) at respective sites will be obtaining data (i.e. change in blood pressure, heart rate, laboratory results, multi disciplinary meeting notes etc.) from Electronic Medical Records (EMR) as eligible patients who have consented are enrolled in this registry study.
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Assessment method [3]
429032
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Timepoint [3]
429032
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Every 12 months (at a minimum or as needed) post study commencement.
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Eligibility
Key inclusion criteria
The participant should be diagnosed as having one of the 5 recognised eating disorder conditions and be in a medically unstable condition due to symptoms and behaviour due to eating disorder (Anorexia Nervosa, Bulimia Nervosa, Avoidant/restrictive food intake disorder, Binge Eating Disorder, OFSED (Other specified feeding or eating disorder)). The diagnosis might be new or existing.
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Minimum age
9
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(a). patients with an eating disorder who are not medically unstable.
(b). patients whose medical instability is not directly related to the symptoms and behaviour of their eating disorder, e.g., someone admitted for pneumonia, but also has an eating disorder, where the pneumonia is not the result of the eating disorder.
(c). patients under the age of 18 years (only applicable to sites that cater for adult patients only)
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Study design
Purpose
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Duration
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Selection
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Timing
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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
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Actual
4/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
14
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
41385
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
314571
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Other
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Name [1]
314571
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South Australian Association of Internal Medicine (SAAIM)
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Address [1]
314571
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L4 The Department of General Medicine, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
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Country [1]
314571
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Australia
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Primary sponsor type
Other
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Name
South Australian Association of Internal Medicine (SAAIM)
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Address
L4 The Department of General Medicine, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
316531
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Address [1]
316531
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Country [1]
316531
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313605
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Central Adelaide Local Health Network (CALHN)
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Ethics committee address [1]
313605
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Port Road, Adelaide, SA 5000
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Ethics committee country [1]
313605
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Australia
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Date submitted for ethics approval [1]
313605
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05/05/2023
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Approval date [1]
313605
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16/05/2023
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Ethics approval number [1]
313605
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Summary
Brief summary
The Lily Registry will aim to:
a. collect data about inpatients with medical complications of eating disorders
b. define the practice and improve outcomes for patients with medical complications of eating disorders
c. encourage translational research, innovation, and clinical leadership in best practice care across South Australia for this important and challenging patient cohort
d. enable excellence in inpatient care of people with medical complications of eating disorders by supporting best-practice multidisciplinary care and continuous quality improvement
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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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Dr Patrick Russell
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Address
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The Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
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Country
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Australia
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Phone
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+61 404 807 880
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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
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Dr Patrick Russell
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Address
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The Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
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Country
128723
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Australia
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Phone
128723
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+61 404 807 880
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Fax
128723
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Email
128723
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[email protected]
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Contact person for scientific queries
Name
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Dr Patrick Russell
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Address
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The Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
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Country
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Australia
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Phone
128724
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+61 404 807 880
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Fax
128724
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Email
128724
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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