ANZCTR - Registration

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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

Condition category

Condition code

Diet and Nutrition

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]

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]

Nutrition level as measured by Patient Generated Subjective Global Assessment (PG-SGA)

Timepoint [1]

Measured at 3 days post-admission and 6 months post-discharge.

Secondary outcome [1]

Lean Body Mass

Timepoint [1]

At 3 days post-admission and 6 months post-discharge.

Secondary outcome [2]

Readmission to hospital

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Newcastle

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Health Human Research Ethics Committee-John Hunter Hospital.

Ethics committee address [1]

John Hunter Hospital, Newcastle, NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/03/2006

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Lynne Parkinson

Address

Research Centre for Gender, Health and Ageing The University of Newcastle David Maddison Clinical Sciences Building University Drive Callaghan NSW 2308

Country

Australia

Phone

+61 2 49236232

Fax

+61 2 49236323

[email protected]

Contact person for scientific queries

Name

Professor Julie Byles

Address

Research Centre for Gender Health and Ageing The University of Newcastle David Maddison Clinical Sciences Building University Drive Callaghan NSW 2308

Country

Australia

Phone

+61 2 49236321

Fax

+61 2 49236323

[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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically