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Trial registered on ANZCTR


Registration number
ACTRN12608000107325
Ethics application status
Not yet submitted
Date submitted
26/02/2008
Date registered
27/02/2008
Date last updated
17/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Thin water consistency being aspirated into the lungs of patients who have been recommended thickened drinks by a Speech Pathologist
Scientific title
A Randomised Controlled Study of the effects of oral intake of water in dysphagic patients who have been prescribed thickened fluids to assess hydration and quality of life.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Swallowing difficulties 2870 0
Condition category
Condition code
Other 3006 3006 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be provided with water between meals following a strict oral hygeine regime that will be completed by nursing staff. Patients will be allowed unlimited amounts of water throughout the day. Patients will not be able to consume water during meals or half an hour post meals. Patients' will be able to consume thickened fluids with meals. The Speech Pathologist will monitor the patient's condition daily (temperature, chest status and medical notes). The duration of the intervention will last 5 days. post the intervention, the patients will remain on thick fluids only dependent on the presription of the Speech Pathologist.
Intervention code [1] 2613 0
Treatment: Other
Comparator / control treatment
Patients will be provided with thickened fluids only
Control group
Active

Outcomes
Primary outcome [1] 3888 0
Hydration levels in patients will increase. Fluid balance charts will be kept and monitored by the Speech Pathologist.
Timepoint [1] 3888 0
6 months
Secondary outcome [1] 6574 0
Quality of life will improve. This will be measured via quality of life surveys pre and post thin fluid stage.
Timepoint [1] 6574 0
6 months

Eligibility
Key inclusion criteria
People who have been prescribed thickened fluids as a result of a Speech Pathology assessment
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with respiratory conditions, tracheostomy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
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] 590 0
3844

Funding & Sponsors
Funding source category [1] 3124 0
Hospital
Name [1] 3124 0
Latrobe Regional Hospital
Address [1] 3124 0
PO Box 424
Traralgon Princes Highway VIC 3844
Country [1] 3124 0
Australia
Primary sponsor type
Hospital
Name
Latrobe Regional Hospital
Address
PO Box 424
Traralgon Princes Highway VIC 3844
Country
Australia
Secondary sponsor category [1] 2811 0
Individual
Name [1] 2811 0
Darebin Aged Care Health Service
Address [1] 2811 0
108 Wales Street
Thornbury VIC 3071
Country [1] 2811 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5100 0
Ethics committee address [1] 5100 0
Ethics committee country [1] 5100 0
Date submitted for ethics approval [1] 5100 0
12/03/2008
Approval date [1] 5100 0
Ethics approval number [1] 5100 0
Ethics committee name [2] 5106 0
Ethics committee address [2] 5106 0
Ethics committee country [2] 5106 0
Date submitted for ethics approval [2] 5106 0
16/04/2008
Approval date [2] 5106 0
Ethics approval number [2] 5106 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28402 0
Address 28402 0
Country 28402 0
Phone 28402 0
Fax 28402 0
Email 28402 0
Contact person for public queries
Name 11559 0
Martha Karagiannis
Address 11559 0
PO Box 424
Traralgon Princes Highway VIC 3844
Country 11559 0
Australia
Phone 11559 0
+61 3 51738383
Fax 11559 0
Email 11559 0
MKaragiannis@lrh.com.au
Contact person for scientific queries
Name 2487 0
Martha Karagiannis
Address 2487 0
PO Box 424
Traralgon Princes Highway VIC 3844
Country 2487 0
Australia
Phone 2487 0
+61 3 51738383
Fax 2487 0
Email 2487 0
MKaragiannis@lrh.com.au

No information has been provided regarding IPD availability
Summary results
No Results