ANZCTR - Registration

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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]

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

Condition category

Condition code

Renal and Urogenital

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]

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]

Assessment of agreement between sodium intake score from the Scored Salt Questionnaire and the gold-standard 24-hour urinary sodium excretion (mmol)

Timepoint [1]

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]

The secondary aim is to describe the habitual sodium intake of a cohort of CKD patients attending hospital outreach clinics.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

4029

Recruitment postcode(s) [2]

4012

Recruitment postcode(s) [3]

4509

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Brisbane and Women's Hospital Foundation and ANZSN-Amgen Quality Assurance Grants

Address [1]

RBWH, Butterfield St, Herston, QLD, 4029

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

Butterfield St, Herston, QLD, 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/03/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Belinda Morey

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

Phone

+61736367997

Fax

+6136361874

Belinda_Morey@health.qld.gov.au

Contact person for scientific queries

Name

Belinda Morey

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

Phone

+61736367997

Fax

+6136361874

Belinda_Morey@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.

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