Trial Review

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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.
Scientific title
Determination of compliance with prescribed nutritional supplements, mid meal snacks and thickened fluids in selected hospitalised patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospitalised patients 181 0
Condition category
Condition code
Diet and Nutrition 205 205 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assistance with prescribed foods and beverages.
Intervention code [1] 69 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care ie prescribed foods and beverages delivered by food service staff.
Control group
Historical

Outcomes
Primary outcome [1] 245 0
Improved nutritional intake
Timepoint [1] 245 0
Measured via daily monitoring of consumptions of prescribed food and beverages
Secondary outcome [1] 552 0
Wastage
Timepoint [1] 552 0
Measured via daily monitoring of consumption.

Eligibility
Key inclusion criteria
Hospitalised patients to give consent and participate in short interview in English.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Unable to conceal allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 259 0
Self funded/Unfunded
Name [1] 259 0
Country [1] 259 0
Primary sponsor type
Charities/Societies/Foundations
Name
St Vincents Health
Address
Country
Australia
Secondary sponsor category [1] 198 0
University
Name [1] 198 0
Deakin University
Address [1] 198 0
Country [1] 198 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36145 0
Address 36145 0
Country 36145 0
Phone 36145 0
Fax 36145 0
Email 36145 0
Contact person for public queries
Name 9258 0
Alison Bowie
Address 9258 0
St Vincents Health
Victoria Pde
Fitzroy VIC 3065
Country 9258 0
Australia
Phone 9258 0
+61 3 92882211 (p. 1203)
Fax 9258 0
Email 9258 0
Alison.Bowie@svhm.org.au
Contact person for scientific queries
Name 186 0
Alison Bowie
Address 186 0
St Vincents Health
Victoria Pde
Fitzroy VIC 3065
Country 186 0
Australia
Phone 186 0
+61 3 92882211 (p. 1203)
Fax 186 0
Email 186 0
Alison.Bowie@svhm.org.au

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.