Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000237583
Ethics application status
Approved
Date submitted
6/06/2006
Date registered
14/06/2006
Date last updated
14/06/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot of a randomised controlled trial of nutrition screening and appropriate support in hospitalised elderly
Scientific title
Pilot of a randomised controlled trial of nutrition screening and appropriate nutrition support for reducing malnutrition in hospitalised elderly.
Universal Trial Number (UTN)
Trial acronym
NUTS RCT Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 1214 0
Condition category
Condition code
Diet and Nutrition 1299 1299 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All consenting patients will be screened using the Malnutrition Screening Tool. Patients randomised to the intervention group will be triaged according to Malnutrition Screening Tool score. Those intervention patients who score less than 2 on the Malnutrition Screening Tool will be provided with the NHMRC dietary guidelines only; those who are screened as "at risk", that is who have a Malnutrition Screening Tool score of 2 to 5, will be referred to a dietitian for Subjective Global Assessment, and, if assessed as malnourished, will be offered multi-disciplinary intervention co-ordinated by a Nutrition Support Person employed by the study, and involving a team of dietitians, social workers, clinical nurse consultants, geriatricians, oral health professionals, speech pathologists, physiotherapists and pharmacists; those who are screened as malnourished, that is who have a Malnutrition Screening Tool score of 6 or more, will be immediately offered multi-disciplinary nutrition support. “Best practice” nutritional care for the latter two groups of patients will be based on the recent Clinical Standards for Food, Fluid and Nutritional Care in Hospitals from Scotland. Intervention will occur during the hospital stay, which is estimated to be up to about 2 weeks, with follow-up at 6 months after discharge.
Intervention code [1] 1127 0
Early detection / Screening
Comparator / control treatment
Control group patients will receive usual care for their presenting condition only, but their Malnutrition Screening Tool score will be provided to staff on a study referral slip.
Control group
Active

Outcomes
Primary outcome [1] 1774 0
Nutrition level as measured by Patient Generated Subjective Global Assessment (PG-SGA)
Timepoint [1] 1774 0
Measured at 3 days post-admission and 6 months post-discharge.
Secondary outcome [1] 3127 0
Lean Body Mass
Timepoint [1] 3127 0
At 3 days post-admission and 6 months post-discharge.
Secondary outcome [2] 3128 0
Readmission to hospital
Timepoint [2] 3128 0
Measured by medical record audit at 6 months post-discharge.

Eligibility
Key inclusion criteria
Are admitted to the John Hunter Hospital in Newcastle, NSW.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not have the cognitive capacity to consent to the study (as advised by Nursing staff), those who do not speak English sufficiently well to understand the study requirements, terminally ill patients, and those who are already receiving parenteral nutrition or other artificial feeding at the time of recruitment.

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)
Research Assistant blind to patient study status. Randomisation will occur at Research Centre for Gender, Health and Ageing, not hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients randomised daily by study data manager, from bed numbers, using random number list
Masking / blinding
Blinded (masking 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
6/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1425 0
University
Name [1] 1425 0
University of Newcastle
Country [1] 1425 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 1253 0
None
Name [1] 1253 0
none
Address [1] 1253 0
Country [1] 1253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2799 0
Hunter New England Health Human Research Ethics Committee-John Hunter Hospital.
Ethics committee address [1] 2799 0
John Hunter Hospital, Newcastle, NSW
Ethics committee country [1] 2799 0
Australia
Date submitted for ethics approval [1] 2799 0
Approval date [1] 2799 0
14/03/2006
Ethics approval number [1] 2799 0
06/02/22/5.04

Summary
Brief summary
This research proposes to pilot the methods for a planned randomised controlled trial (RCT) which will test the hypothesis that in-patients aged 65 years and over who are randomly allocated to be screened for nutritional status and to receive appropriate nutritional support will have fewer negative health outcomes, compared to those who receive usual practice. The pilot study will test the feasibility of a multi-disciplinary nutritional support intervention for the population of older people who are at high risk of malnutrition and associated adverse health outcomes, while optimising the activities of a range of existing health services and patient support approaches. This study will implement a simple and efficient form of nutrition screening for men and women aged 65 years and over, who are admitted to the John Hunter Hospital in Newcastle, NSW. Consenting patients will be screened for under-nutrition using the Malnutrition Screening Tool by a Research Assistant who will remain blind to patient study status. Patients will then be randomly allocated, by a data manager, to either the control group, who will receive usual care for their presenting problem, or to the intervention. Patients within the intervention component of the study will be reviewed by a dedicated Nutrition Support Person employed by the study. “Best practice” nutritional care for these patients will be based on the recent Clinical Standards for Food, Fluid and Nutritional Care in Hospitals from Scotland. It is expected that patients will not know which condition they are randomized to, as the intervention is designed to fit seamlessly within normal hospital practice and routines. Follow-up data collection will occur at 6 months post-discharge, and will be conducted by the same Research Assistant as conducted baseline data collection, who will remain blind to patient study status. The main outcomes measures for the pilot will be a change in nutrition status from recruitment to follow-up using the Patient Generated SGA (PG-SGA), and Lean Body Mass.
The findings from this study will provide a test of the feasibility of the RCT, which it is hoped will provide a much needed basis for targeting nutritional assessment and services in a growing population of older people, and would be expected to have a major impact on enhancing recovery and quality of life, and reducing length of stay and readmission for those people involved in the intervention component.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35274 0
Address 35274 0
Country 35274 0
Phone 35274 0
Fax 35274 0
Email 35274 0
Contact person for public queries
Name 10316 0
Dr Lynne Parkinson
Address 10316 0
Research Centre for Gender, Health and Ageing
The University of Newcastle
David Maddison Clinical Sciences Building
University Drive
Callaghan NSW 2308
Country 10316 0
Australia
Phone 10316 0
+61 2 49236232
Fax 10316 0
+61 2 49236323
Email 10316 0
[email protected]
Contact person for scientific queries
Name 1244 0
Professor Julie Byles
Address 1244 0
Research Centre for Gender Health and Ageing
The University of Newcastle
David Maddison Clinical Sciences Building
University Drive
Callaghan NSW 2308
Country 1244 0
Australia
Phone 1244 0
+61 2 49236321
Fax 1244 0
+61 2 49236323
Email 1244 0
[email protected]

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
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