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Trial registered on ANZCTR
Registration number
ACTRN12605000100695
Ethics application status
Approved
Date submitted
26/07/2005
Date registered
9/08/2005
Date last updated
9/08/2005
Type of registration
Prospectively registered
Titles & IDs
Public title
Determination of compliance with prescribed nutritional supplements, mid meal snacks and thickened fluids in selected hospitalised patients.
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Scientific title
Determination of compliance with prescribed nutritional supplements, mid meal snacks and thickened fluids in selected hospitalised patients.
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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:
Hospitalised patients
181
0
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Condition category
Condition code
Diet and Nutrition
205
205
0
0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Assistance with prescribed foods and beverages.
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Intervention code [1]
69
0
Treatment: Other
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Comparator / control treatment
The control group will receive usual care ie prescribed foods and beverages delivered by food service staff.
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Control group
Historical
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Outcomes
Primary outcome [1]
245
0
Improved nutritional intake
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Assessment method [1]
245
0
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Timepoint [1]
245
0
Measured via daily monitoring of consumptions of prescribed food and beverages
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Secondary outcome [1]
552
0
Wastage
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Assessment method [1]
552
0
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Timepoint [1]
552
0
Measured via daily monitoring of consumption.
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Eligibility
Key inclusion criteria
Hospitalised patients to give consent and participate in short interview in English.
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Minimum age
18
Years
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Maximum age
Not stated
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Unable to conceal allocation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
5/09/2005
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Actual
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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
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
259
0
Self funded/Unfunded
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Name [1]
259
0
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Address [1]
259
0
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Country [1]
259
0
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Primary sponsor type
Charities/Societies/Foundations
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Name
St Vincents Health
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Address
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Country
Australia
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Secondary sponsor category [1]
198
0
University
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Name [1]
198
0
Deakin University
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Address [1]
198
0
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Country [1]
198
0
Australia
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
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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
36145
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Address
36145
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Country
36145
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Phone
36145
0
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Fax
36145
0
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Email
36145
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Contact person for public queries
Name
9258
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Alison Bowie
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Address
9258
0
St Vincents Health
Victoria Pde
Fitzroy VIC 3065
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Country
9258
0
Australia
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Phone
9258
0
+61 3 92882211 (p. 1203)
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Fax
9258
0
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Email
9258
0
[email protected]
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Contact person for scientific queries
Name
186
0
Alison Bowie
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Address
186
0
St Vincents Health
Victoria Pde
Fitzroy VIC 3065
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Country
186
0
Australia
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Phone
186
0
+61 3 92882211 (p. 1203)
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Fax
186
0
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Email
186
0
[email protected]
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No information has been provided regarding IPD availability
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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