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Trial registered on ANZCTR


Registration number
ACTRN12610000526077
Ethics application status
Approved
Date submitted
24/06/2010
Date registered
25/06/2010
Date last updated
22/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised control trial assessing outcomes of two service models providing nutritional support to older people presenting to the Emergency Department
Scientific title
In older patients presenting to the Emergency Department, do those who receive a nutrition intervention achieve a better nutritional status than those who receive standard care only? A comparison of two service models.
Secondary ID [1] 252064 0
nil
Universal Trial Number (UTN)
Trial acronym
NED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutritional Status of Older people presenting to Emergency Department 257602 0
Condition category
Condition code
Diet and Nutrition 257777 257777 0 0
Other diet and nutrition disorders
Public Health 257828 257828 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individualised nutritional care from a dietitian, beginning on the day of presentation to Emergency Department, with monthly follow-up over the phone for a three month period.
Intervention code [1] 256691 0
Lifestyle
Intervention code [2] 256724 0
Treatment: Other
Comparator / control treatment
Usual care as per Community Hospital Interface Program (CHIP) nursing staff and community support
Control group
Active

Outcomes
Primary outcome [1] 258665 0
Weight assessed using bioelectrical impedance analysis (BIA) scales
Timepoint [1] 258665 0
Assessed on Baseline and again after 3 months
Primary outcome [2] 258666 0
Nutritional Status assessed via Subjective Global Assessment (SGA) and Patient Generated Subjective Global Assessment (PGSGA)
Timepoint [2] 258666 0
Assessed on Baseline and again after 3 months
Primary outcome [3] 258681 0
Protein and Energy Intake assessed using 24 hour recall entered into the Food Works (Registered Trademark) software program
Timepoint [3] 258681 0
Assessed on Baseline and again after 3 months
Secondary outcome [1] 264643 0
Quality of Life assessed by the EuroQol 5 dimension questionnaire (EQ-5D)
Timepoint [1] 264643 0
Assessed on Baseline and again after 3 months
Secondary outcome [2] 264691 0
Geriatric depression scale (GDS)
Timepoint [2] 264691 0
Assessed on Baseline and again after 3 months
Secondary outcome [3] 264692 0
Alcohol use disorders identification test (AUDIT)
Timepoint [3] 264692 0
Assessed on Baseline and again after 3 months
Secondary outcome [4] 264693 0
Incidence of falls and fractures resulting from falls as reported by patient
Timepoint [4] 264693 0
incidence of falls assessed for 6 months immediately prior to baseline, and from baseline for 3 months
Secondary outcome [5] 264694 0
Hospital and Emergency Department admissions assessed through Hospital Information Management Services
Timepoint [5] 264694 0
Over 3 months from date of randomisation
Secondary outcome [6] 264695 0
Length of stay assessed through Hospital Information Management Services
Timepoint [6] 264695 0
Over 3 months from date of randomisation
Secondary outcome [7] 264696 0
incidence of pressure ulcers assessed through Hospital Information Management Services
Timepoint [7] 264696 0
Over 3 months from date of randomisation
Secondary outcome [8] 264697 0
Death assessed through Hospital Information Management Services
Timepoint [8] 264697 0
Over 3 months from date of randomisation

Eligibility
Key inclusion criteria
a) admitted to Emergency Department
b) aged 60 years or over
c) assessed at malnutrition risk using the Malnutrition Screening Tool (MST)
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) unable to receive informed consent
b) Triage Category 1 (highest priority)
c) already receiving dietetic care
d) admitted from a health care facility (including nursing home)

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)
Randomised sequence, randomly generated numbers sealed in sequentially numbered opaque envelopes
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/10/2009
Actual
28/10/2009
Date of last participant enrolment
Anticipated
Actual
20/04/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 257170 0
Government body
Name [1] 257170 0
Queensland Health - Health practitioner research scheme
Country [1] 257170 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Ipswich Road,
Woolloongabba
Queensland 4102
Country
Australia
Secondary sponsor category [1] 256450 0
None
Name [1] 256450 0
N/A
Address [1] 256450 0
N/A
Country [1] 256450 0
Other collaborator category [1] 251346 0
Individual
Name [1] 251346 0
Dr Angela Vivanti
Address [1] 251346 0
Dept Nutrition and Dietetics
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane QLD 4102
Country [1] 251346 0
Australia
Other collaborator category [2] 251347 0
Individual
Name [2] 251347 0
Dr Maree Ferguson
Address [2] 251347 0
Dept Nutrition and Dietetics
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane QLD 4102
Country [2] 251347 0
Australia
Other collaborator category [3] 251348 0
Individual
Name [3] 251348 0
Dr Darren Powrie
Address [3] 251348 0
Emergency Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane QLD 4102
Country [3] 251348 0
Australia
Other collaborator category [4] 251349 0
Individual
Name [4] 251349 0
Mr Darren Clark
Address [4] 251349 0
Emergency Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane QLD 4102
Country [4] 251349 0
Australia
Other collaborator category [5] 251350 0
Individual
Name [5] 251350 0
Ms Maria O'Neill
Address [5] 251350 0
Senior Decision Support Officer
Health Information Management Services
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane QLD 4102
Country [5] 251350 0
Australia
Other collaborator category [6] 251351 0
Individual
Name [6] 251351 0
Dr Liz Isenring
Address [6] 251351 0
Senior Lecturer
Master Of dietetics
Faculty of health sciences
university of Queensland
Brisbane QLD 4072
Country [6] 251351 0
Australia
Other collaborator category [7] 251352 0
Individual
Name [7] 251352 0
Dr Katrina Campbell
Address [7] 251352 0
Dept Nutrition and Dietetics
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane QLD 4102
Country [7] 251352 0
Australia
Other collaborator category [8] 251353 0
Individual
Name [8] 251353 0
Ms Sally Courtice
Address [8] 251353 0
Dept Nutrition and Dietetics
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane QLD 4102
Country [8] 251353 0
Australia
Other collaborator category [9] 251354 0
Individual
Name [9] 251354 0
Ms Sarah Anthony
Address [9] 251354 0
Dept Nutrition and Dietetics
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane QLD 4102
Country [9] 251354 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259212 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 259212 0
Ethics committee country [1] 259212 0
Australia
Date submitted for ethics approval [1] 259212 0
Approval date [1] 259212 0
09/09/2009
Ethics approval number [1] 259212 0
HREC/09/QPAH/130

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

Contacts
Principal investigator
Name 31309 0
Dr Angela Vivanti
Address 31309 0
Dept Nutrition and Dietetics
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba,
Queensland, 4102
Australia
Country 31309 0
Australia
Phone 31309 0
+61 7 3176 7938
Fax 31309 0
Email 31309 0
angela.vivanti@health.qld.gov.au
Contact person for public queries
Name 14556 0
Angela Vivanti
Address 14556 0
Department of Nutrition and Dietetics
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 14556 0
Australia
Phone 14556 0
+61 7 3176 7938
Fax 14556 0
+61 7 3176 5619
Email 14556 0
angela.vivanti@health.qld.gov.au
Contact person for scientific queries
Name 5484 0
Angela Vivanti
Address 5484 0
Department of Nutrition and Dietetics
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 5484 0
Australia
Phone 5484 0
+61 7 3176 7938
Fax 5484 0
+61 7 3176 5619
Email 5484 0
angela.vivanti@health.qld.gov.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.