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Trial registered on ANZCTR


Registration number
ACTRN12624000472572
Ethics application status
Approved
Date submitted
10/01/2024
Date registered
16/04/2024
Date last updated
16/04/2024
Date data sharing statement initially provided
16/04/2024
Date results information initially provided
16/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutrition ALD: Effect of screening tool for malnutrition in advanced liver disease.
Scientific title
Nutrition ALD: Effect of screening tool for malnutrition in advanced liver disease: a patient-driven, value-based approach to medical nutrition therapy.
Secondary ID [1] 311236 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Liver Disease 332443 0
Malnutrition screening 332444 0
Condition category
Condition code
Diet and Nutrition 329135 329135 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 329136 329136 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aiming to develop and examine the acceptability, feasibility and effectiveness of a malnutrition screening tool encompassing physiological, psychosocial, emotional, financial, and cultural determinants of malnutrition for patients with ALD (with or without ascites). The tool will consist of yes/no questions relating to weight, appetite and physical symptoms along with non physiological factors affecting oral intake.

Patients will be seen during a once only face to face (or via phone) standard care appointment at one regional and one metropolitan hospital liver service outpatient clinic, day stay or acute care inpatient admission. Data will be captured and stored using Redcap.
Baseline Data:
Baseline characteristics including measures of nutritional status (including anthropometry and bioimpedance monitoring) will be collected on each patient participant. Measurements will include Child Pugh classification and Charlson Comorbidity Index (CCI). Child Pugh classification will be calculated by existing gastroenterology clinicians from patient medical records. CCI will be collected via administrative data extract of patients’ electronic medical records during statistical analysis. Any data will be collected by the research team after the participants have provided informed consent.

Intervention:
A 30 minute pre-trial interview will be conducted consisting of semi-structured interviews at the first point of contact in standard care clinics. This may be weeks to months in advance of the intervention pending clinic appointments. At the following standard care clinic appointment all screening tools and assessments will be conducted in one 30 minute session. The Integrated Palliative care Outcome Scale (IPOS) will assess the physiological, psychosocial, emotional, financial, and cultural impacts of nutrition (or malnutrition) on health and quality of life for each participant, this tool will take less than 15 minutes to complete. Each participant will then complete four malnutrition screening tools: Royal Free Hospital-Nutrition Prioritising Tool (RFH-NPT), Malnutrition Screening Tool (MST), Patient Generated-Subjective Global Assessment Short Form (PGSGASF) and our novel malnutrition screening tool. Each screening tool takes approximately 5 minutes or less to complete. The Subjective Global Assessment (SGA) will be completed as per standard care practice with the research Dietitian and/or Dietitian Honours student.
Intervention code [1] 327692 0
Early detection / Screening
Comparator / control treatment
Outcomes of the screening tools will be compared with anthropometric assessment including weight, Bioelectrical impedance, mid upper arm circumference and hand grip strength as well as the SGA score as part of standard care.
Control group
Active

Outcomes
Primary outcome [1] 336969 0
Specificity will be assessed independently for the novel malnutrition screening tool to identify malnutrition compared to diagnostic anthropometric assessment (SGA, hand grip strength, Mid upper arm circumference (MUAC), Body Mass Index (BMI), Bioimpedance).
Timepoint [1] 336969 0
Baseline, day of intervention.
Primary outcome [2] 336970 0
Cross-sectional review of malnutrition-related symptom burden and quality of life (Integrated Palliative Care Outcome Scale (IPOS)) This will be a composite measure.
Timepoint [2] 336970 0
Baseline, day of intervention.
Primary outcome [3] 336971 0
Qualitative analysis of acceptability of the screening tool (patient/carer interview)
Timepoint [3] 336971 0
Baseline, day of intervention.
Secondary outcome [1] 432766 0
Specificity will be assessed independently for the MST to identify malnutrition compared to diagnostic anthropometric assessment (SGA, hand grip strength, Mid upper arm circumference (MUAC), Body Mass Index (BMI), Bioimpedance). This is a primary outcome.
Timepoint [1] 432766 0
Baseline day of intervention.
Secondary outcome [2] 432767 0
Specificity will be assessed independently for the PG-SGA SF to identify malnutrition compared to diagnostic anthropometric assessment (SGA, hand grip strength, Mid upper arm circumference (MUAC), Body Mass Index (BMI), Bioimpedance). This is a primary outcome.
Timepoint [2] 432767 0
Baseline, day of intervention.
Secondary outcome [3] 432768 0
Specificity will be assessed independently for the RFH-NPT to identify malnutrition compared to diagnostic anthropometric assessment (SGA, hand grip strength, Mid upper arm circumference (MUAC), Body Mass Index (BMI), Bioimpedance). This is a primary outcome.
Timepoint [3] 432768 0
Baseline, day of intervention.
Secondary outcome [4] 432769 0
Qualitative analysis of feasibility of the screening tool (patient/carer interview)
Timepoint [4] 432769 0
Baseline, at intervention.
Secondary outcome [5] 432770 0
Qualitative analysis of acceptability of the screening tool (clinician interview)
Timepoint [5] 432770 0
Baseline, at intervention.
Secondary outcome [6] 432771 0
Qualitative analysis of feasibility of the screening tool (clinician interview)
Timepoint [6] 432771 0
Baseline at intervention.
Secondary outcome [7] 433497 0
Sensitivity will be assessed independently for the novel malnutrition screening tool to identify malnutrition compared to diagnostic anthropometric assessment (SGA, hand grip strength, Mid upper arm circumference (MUAC), Body Mass Index (BMI), Bioimpedance). This is a primary outcome.
Timepoint [7] 433497 0
Baseline, day of intervention.
Secondary outcome [8] 433498 0
Sensitivity will be assessed independently for the MST to identify malnutrition compared to diagnostic anthropometric assessment (SGA, hand grip strength, Mid upper arm circumference (MUAC), Body Mass Index (BMI), Bioimpedance). This is a primary outcome.
Timepoint [8] 433498 0
Baseline, day of intervention.
Secondary outcome [9] 433499 0
Sensitivity will be assessed independently for the PG-SGA SF to identify malnutrition compared to diagnostic anthropometric assessment (SGA, hand grip strength, Mid upper arm circumference (MUAC), Body Mass Index (BMI), Bioimpedance). This is a primary outcome.
Timepoint [9] 433499 0
Baseline, day of intervention.
Secondary outcome [10] 433500 0
Sensitivity will be assessed independently for the RFH-NPT to identify malnutrition compared to diagnostic anthropometric assessment (SGA, hand grip strength, Mid upper arm circumference (MUAC), Body Mass Index (BMI), Bioimpedance). This is a primary outcome.
Timepoint [10] 433500 0
Baseline, day of intervention.

Eligibility
Key inclusion criteria
Patients aged 18 years and over with Child Pugh B or C liver disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those unable to provide consent.

Study design
Purpose of the study
Diagnosis
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
Other
Other design features
All patients will be administered the screening tools and reference standard diagnostic assessment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SGA will be treated as a dichotomised measure to yield a diagnosis of malnutrition or not. Evaluation of RFH-NPT, MST, PG-SGA SF, and the novel malnutrition screening tool will be via comparison to the validated SGA using a 2 x 2 table to calculate sensitivity, specificity and area under the ROC curve (AUROC). The AUROC of the standard screening tools vs the new screening tool will be compared to see if there is a significant increment in predictive ability. In the event that the new screening tool does not perform better than the existing ones then a logistic regression model will be constructed de novo from the individual variables to create a new screening tool which maximises AUROC.

We will aim for a sample size of 50 participants. Assuming that ~80% of participants will be malnourished, 50 people will allow us to detect an AUROC of 0.80 with 80% power at p=0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/05/2023
Date of last participant enrolment
Anticipated
Actual
18/01/2024
Date of last data collection
Anticipated
Actual
18/01/2024
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25961 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 25962 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment postcode(s) [1] 41803 0
2305 - New Lambton
Recruitment postcode(s) [2] 41804 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 315492 0
Charities/Societies/Foundations
Name [1] 315492 0
John Hunter Hospital Charitable Trust
Country [1] 315492 0
Australia
Funding source category [2] 315493 0
Other Collaborative groups
Name [2] 315493 0
Hunter Medical Research Institute
Country [2] 315493 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Dr Katie Wynne
Address
John Hunter Hospital, New Lambton Heights.
Country
Australia
Secondary sponsor category [1] 317568 0
None
Name [1] 317568 0
Address [1] 317568 0
Country [1] 317568 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314396 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 314396 0
John Hunter Hospital, Locked Bag 1, New Lambton Heights, NSW, 2305
Ethics committee country [1] 314396 0
Australia
Date submitted for ethics approval [1] 314396 0
28/11/2022
Approval date [1] 314396 0
21/12/2022
Ethics approval number [1] 314396 0
(2022/ETH02426)

Summary
Brief summary
The primary aim of this research is to develop and examine the acceptability, feasibility and effectiveness of a malnutrition screening tool encompassing physiological, psychosocial, emotional, financial, and cultural determinants of malnutrition for patients with ALD (with or without ascites).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131434 0
A/Prof Katie Wynne
Address 131434 0
John Hunter Hospital, Locked Bag 1, New Lambton Heights, NSW 2305.
Country 131434 0
Australia
Phone 131434 0
+61 429 995 896
Fax 131434 0
Email 131434 0
KatieJane.Wynne@health.nsw.gov.au
Contact person for public queries
Name 131435 0
Mrs Shaye Ludlow
Address 131435 0
John Hunter Hospital, Locked Bag 1, New Lambton Heights, NSW 2305.
Country 131435 0
Australia
Phone 131435 0
+61 02 49213686
Fax 131435 0
Email 131435 0
Shaye.Ludlow@health.nsw.gov.au
Contact person for scientific queries
Name 131436 0
A/Prof Katie Wynne
Address 131436 0
John Hunter Hospital, Locked Bag 1, New Lambton Heights, NSW 2305.
Country 131436 0
Australia
Phone 131436 0
+61 429 995 896
Fax 131436 0
Email 131436 0
KatieJane.Wynne@health.nsw.gov.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21869Study protocol  KatieJane.Wynne@health.nsw.gov.au Shaye.Ludlow@health.nsw.gov.au



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.