Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000356965
Ethics application status
Approved
Date submitted
5/04/2011
Date registered
5/04/2011
Date last updated
16/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Validating a Scored Salt Questionnaire against Urinary Sodium Excretion in Patients with Chronic Kidney Disease
Scientific title
Validating a Scored Salt Questionnaire against Urinary Sodium Excretion in Patients with Chronic Kidney Disease
Secondary ID [1] 259932 0
Nil
Universal Trial Number (UTN)
U1111-1120-5489
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 265528 0
Condition category
Condition code
Renal and Urogenital 265689 265689 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross-sectional validation study of a Scored Salt Questionnaire (SSQ). The SSQ is a self-administered and scored questionnaire consisting of 30 questions relating to common foods and sodium-related behaviour patterns identified from food records collected previously from the local renal population. To validate this tool, assessment of agreement between sodium intake score from the SSQ and the gold-standard 24-hour urinary sodium excretion (mmol) will be undertaken using Bland-Altman plat and inter-class correlation. It is anticipated this study will take 18months in total including data analysis and write-up.
Intervention code [1] 264345 0
Not applicable
Comparator / control treatment
24 hour urinary sodium excretion - widely accepted as the preferred method of assessment of intake
Control group
Active

Outcomes
Primary outcome [1] 266464 0
Assessment of agreement between sodium intake score from the Scored Salt Questionnaire and the gold-standard 24-hour urinary sodium excretion (mmol)
Timepoint [1] 266464 0
Scored Salt Questionnaire completed on the day participants finish the 24-hour urine collection. The assessment of agreement will occur at the end of the study once all data has been collected.
Secondary outcome [1] 273816 0
The secondary aim is to describe the habitual sodium intake of a cohort of CKD patients attending hospital outreach clinics.
Timepoint [1] 273816 0
This will occur at the end of the study once all data has been collected.

Eligibility
Key inclusion criteria
Patients with CKD stages 3, 4, or 5
Stable condition and medications
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with CKD stages 1 and 2
Primary language other than English (only if limits ability to carry out study requirements)
<18 years of age
Women who are pregnant
Patients lacking the capacity to give consent for themselves or the cognitive ability to participate e.g. dementia
Patients who have recently commenced diuretic medications i.e. in the last week
Patients with known poor compliance
Patients with salt losing nephropathy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3893 0
4029
Recruitment postcode(s) [2] 3894 0
4012
Recruitment postcode(s) [3] 3895 0
4509

Funding & Sponsors
Funding source category [1] 264807 0
Charities/Societies/Foundations
Name [1] 264807 0
Royal Brisbane and Women's Hospital Foundation and ANZSN-Amgen Quality Assurance Grants
Country [1] 264807 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Department of Nutrition and Dietetics, Level 2, Dr James Mayne Building, Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 263917 0
None
Name [1] 263917 0
Address [1] 263917 0
Country [1] 263917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266782 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 266782 0
Butterfield St, Herston, QLD, 4029
Ethics committee country [1] 266782 0
Australia
Date submitted for ethics approval [1] 266782 0
Approval date [1] 266782 0
25/03/2011
Ethics approval number [1] 266782 0
HREC/10/QRBW/464

Summary
Brief summary
The purpose of this research is to validate a Scored Sodium Questionnaire (SSQ) as a quick and easy clinical and research tool for assessing salt intake in renal patients.

Evidence Based Practice Guidelines internationally recommend a low sodium diet for renal patients to assist in the management of and retard progression in chronic kidney disease (CKD) 1-9. While dietary counselling is effective in lowering dietary sodium, the prevalence of this disease is increasing rapidly, making it impossible to provide individualised dietary education to all patients. It is essential that finite dietetic resources are directed at those with the greatest need for dietary intervention. Therefore, it is important that clinicians and researchers have a reliable and convenient method of screening and assessing dietary sodium intake to assist in identifying patients who would benefit most from individualised dietetic education and counselling support. Current methods for assessing dietary sodium intake are time consuming, subject to inter-rater variability and are therefore rarely used in the clinical setting. In addition, the gold standard (24-hour urinary sodium) is time consuming, costly and intrusive.

A self-administered SSQ was recently developed by dietitians and researchers at the Royal Brisbane and Women’s Hospital (RBWH) but has not yet been validated in the target population.

Research design: Cross-sectional validation study involving 90 consecutive patients with CKD visiting the Nundah or North Lakes Kidney Health Clinics. Consented participants will be asked to complete the SSQ and a 24-hour food record as well as provide 24-hour urine collections for estimating urinary sodium excretion (urine samples are collected as part of routine care). To validate the SSQ in this population, dietary sodium intake (grams) will be calculated using the tool, confirmed by comparing to 24-hour urinary sodium excretion (grams/day) (gold standard), and cross checked against sodium intake assessed by the 24-hour food record. Steps will also be taken to investigate which parts/questions in the SSQ are more strongly correlated to predict a higher sodium intake, so that clinical referral for dietetic resources can be directed accordingly (screening section of the tool).

A valid tool will provide clinicians and researchers with a quick and efficient method of assessing patients’ sodium intakes without the need for intensive dietary interviewing and analysis. In addition, the screening section could be used by non-dietetic staff to identify patients with higher sodium intakes for dietetic referral.
Trial website
Nil
Trial related presentations / publications
International Congress on Nutrition and Metabolism (2010):
Gill E, Marshall L, Ross L, Ash S. Development of the Scored Salt Questionnaire for the rapid assessment of dietary sodium intake in renal patients within the clinical setting (in press).

Australia and New Zealand Society of Nephrology (2009):
Marshall L, Gill E, Ross L, Ash, S. Identification of Foods Making a Significant Contribution to the Total Dietary Sodium Intakes of Brisbane Renal Patients. Nephrology 2010; Vol 15 (s4) 1-101.
Gill E, Yang C, Gillen L, Lloyd L, Kark A, Healy H. Validating a Scored Salt Questionnaire against Qualitative Sat Assessment in Renal Patients. Nephrology 2009; Vol 14 (s1) A1-A61.
Public notes

Contacts
Principal investigator
Name 32441 0
Address 32441 0
Country 32441 0
Phone 32441 0
Fax 32441 0
Email 32441 0
Contact person for public queries
Name 15688 0
Belinda Morey
Address 15688 0
Department of Nutrition and Dietetics, Level 2, Dr James Mayne Building, Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4029
Country 15688 0
Australia
Phone 15688 0
+61736367997
Fax 15688 0
+6136361874
Email 15688 0
[email protected]
Contact person for scientific queries
Name 6616 0
Belinda Morey
Address 6616 0
Department of Nutrition and Dietetics, Level 2, Dr James Mayne Building, Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4029
Country 6616 0
Australia
Phone 6616 0
+61736367997
Fax 6616 0
+6136361874
Email 6616 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
No additional documents have been identified.