Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01179321




Registration number
NCT01179321
Ethics application status
Date submitted
10/08/2010
Date registered
11/08/2010
Date last updated
11/08/2010

Titles & IDs
Public title
Malnutrition Screening in Acute Aged Care
Scientific title
Malnutrition Screening and Intervention in Hospitalised Older Patients: A Randomised Controlled Trial
Secondary ID [1] 0 0
malscreen05/185
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Early referral to Dietitian for assessment and nutrition support

No Intervention: Control -

Experimental: Early nutrition intervention -


Other interventions: Early referral to Dietitian for assessment and nutrition support
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Length of stay
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- admitted under a geriatrician into one of 2 acute geriatric medicine wards of the
hospital
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- expected length of stay less than 72 hours

- palliative (not for active treatment)

- unable to be nutritionally assessed (non english speaking, severe dementia/confusion
and non cooperative/refused)

- already seen by dietitian during current admission

- enrolled in the study during previous admission

Study design
Purpose of the study
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
Prince of Wales Hospital, Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the impact of malnutrition screening and nutrition
intervention on acute aged care patient outcomes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01179321
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Margaret M Holyday, B.Sc
Address 0 0
Prince of Wales Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01179321