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Trial registered on ANZCTR
Registration number
ACTRN12613000318785
Ethics application status
Approved
Date submitted
17/03/2013
Date registered
21/03/2013
Date last updated
21/03/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Can the use of a rapid nutrition screening tool facilitate timely dietetic referrals on the acute renal wards? – A validation study
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Scientific title
Can the use of a rapid nutrition screening tool facilitate timely dietetic referrals on the acute renal wards? – A validation study
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Secondary ID [1]
282124
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Nil Known
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Universal Trial Number (UTN)
Nil
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nutrition screening
288620
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Kidney disease
288657
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Condition category
Condition code
Diet and Nutrition
288952
288952
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0
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Other diet and nutrition disorders
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Renal and Urogenital
288999
288999
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0
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Kidney disease
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Public Health
289000
289000
0
0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study uses a prospective blind comparison to a gold standard study design. It will take place in the acute renal ward in Middlemore Hospital, Auckland, New Zealand. Consenting patients (n=229) admitted to the ward will be recruited over a period of eight weeks. The undernutrition risk of each renal inpatient identified by the newly developed nutrition screening tool will be compared with their nutrition status assessed using the subjective global assessment and hand grip strength for validity. In the ward setting, the number and accuracy of dietetic referrals will be measured before and after implementation of the proposed tool. The newly developed screening tool is divided into two parts with nine questions regarding to weight loss in the past 30 days, appetite, oral intake and biochemical markers. Part one contains five compulsory questions. If a patient scores three or more in part one, a dietetic referral is generated. This means that this patient may be at risk of undernutrition requiring dietetic interventions. If a patient scores less than three in part one, part two consisting of four additional questions should be completed. If the total score of both part one and part two is three or more, a referral will be generated. The gold standard is aimed at providing a full nutrition assessment, ideally requiring significant dietetic input. However, the proposed tool is designed to be quick and easy so that it can be administered and completed by the nursing staff in approximately five minutes within 48 hours of admission.
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Intervention code [1]
286729
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Early detection / Screening
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Comparator / control treatment
This study is investigating the reliability and validity of a screening tool by assessing inter-rater reliability and construct validity. There is no undernutrition screening currently operating on the ward level. However, the current standard dietetic referral practices in the acute renal ward are self dietetic referrals by the patients, oral or written referrals by the ward nursing staff, or direct referrals by the ward dietitians.
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Control group
Active
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Outcomes
Primary outcome [1]
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TThe effectiveness of this proposed nutrition screening tool in recognising renal inpatients at risk of undernutrition in comparison with undernutrition assessments. Subjective global assessment and hand grip results will be used as the gold standard for assessing the sensitivity and specificity of the screening tool. Area under the receiver operating characteristic (ROC) curve, sensitivity and specificity, positive predictive value and negative predictive value and their 95% confidence intervals will be summarised. Multiple logistic regression models will be used to correlate results from the screening tool against the gold standard results, adjusted by patients’ characteristics.
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Assessment method [1]
289080
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Timepoint [1]
289080
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After the implementation of the tool on the ward level over a period of eight weeks or until the number of participants reaches 229.
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Secondary outcome [1]
301710
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The acceptability of the newly developed screening tool as a standard practice by nursing staff on the renal ward using a qualitative survey with open ended questions.
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Assessment method [1]
301710
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Timepoint [1]
301710
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After the implementation of the tool on ward level at the end of the eight week period.
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Eligibility
Key inclusion criteria
Inclusion criteria: any patients admitted on Ward one due to acute kidney injury, chronic renal failure, and established renal failure (on haemodialysis, peritoneal dialysis or transplant).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria: patients with learning disabilities, mental illness, dementia, terminal illness, being unconscious, emergency situations, and inability to consent for themselves.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients admitted into the ward will have a chance to participate in the study (i.e. all cultural, religious, social, and
ethnic groups will be included). All study participants will receive two types of nutrition screening, whereby the effectiveness of the proposed screening tool will only be compared to the gold standard.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/04/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
229
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4932
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New Zealand
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State/province [1]
4932
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Auckland
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Funding & Sponsors
Funding source category [1]
286892
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University
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Name [1]
286892
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Massey University
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Address [1]
286892
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Institute of Food Nutrition and Human Health,
Massey University
Eastbourne Rd
Building 22
Gate 4
Oteha Rohe Campus
Albany
Auckland 0632
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Country [1]
286892
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New Zealand
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Primary sponsor type
University
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Name
Institute of Food Nutrition and Human Health, Massey University
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Address
Institute of Food Nutrition and Human Health
Massey University
Eastbourne Rd
Building 22
Gate 4
Oteha Rohe Campus
Albany
Auckland 0632
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Country
New Zealand
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Secondary sponsor category [1]
285692
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None
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Name [1]
285692
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Address [1]
285692
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Country [1]
285692
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Other collaborator category [1]
277322
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Hospital
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Name [1]
277322
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Counties Manukau District Health Board
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Address [1]
277322
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Nutrition services,
Middlemore Hospital
Private bag 93311
Otahuhu
Auckland 1062
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Country [1]
277322
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288954
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Northen A Health and Disability Ethics Committee
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Ethics committee address [1]
288954
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Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6011
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Ethics committee country [1]
288954
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New Zealand
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Date submitted for ethics approval [1]
288954
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Approval date [1]
288954
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17/01/2013
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Ethics approval number [1]
288954
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13/NTA/1
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Summary
Brief summary
Undernutrition in patients with renal failure is associated with longer hospital stay, reduced quality of life and increased morbidity and mortality. However, undernutrition is a condition that can only be treated once it has been identified. There have been many nutritional screening tools that were developed in various care settings worldwide. However, the incidence of undernutrition in hospital and failure to recognise or to refer for further nutrition assessments remain high. Since renal patients are particularly vulnerable to undernutrition, the development of a rapid nutrition screening tool that could be easily administered by the renal nursing staff without the requirement of dietetic training would be valuable. Hence, patients who may be malnourished can be accurately identified and referred to the dietetic services. These timely referrals can avoid the deterioration of nutrition status and reduce hospital stay and further complications among them.
The aim of this study is to develop and validate a rapid nutrition screening tool that is specific and sensitive to recognise renal inpatients at risk of undernutrition. The study will monitor the accuracy of the normal ward referral practice in identifying patients at risk of undernutrition and explore the acceptability of this new screening tool by the renal nursing staff.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
38486
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Mr Andrew Xia
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Address
38486
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Private Bag 102 904
Institute of Food, Nutrition and Human Health
Massey University
Auckland 0745
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Country
38486
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New Zealand
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Phone
38486
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+6421887730
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Fax
38486
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Email
38486
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[email protected]
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Contact person for public queries
Name
38487
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Mr Andrew Xia
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Address
38487
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Private Bag 102 904
Institute of Food, Nutrition and Human Health
Massey University
Auckland 0745
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Country
38487
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New Zealand
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Phone
38487
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+6421887730
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Fax
38487
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Email
38487
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[email protected]
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Contact person for scientific queries
Name
38488
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Mr Andrew Xia
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Address
38488
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Private Bag 102 904
Institute of Food, Nutrition and Human Health
Massey University
Auckland 0745
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Country
38488
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New Zealand
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Phone
38488
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+6421887730
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Fax
38488
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Email
38488
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[email protected]
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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.
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