Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000797279
Ethics application status
Not yet submitted
Date submitted
8/09/2009
Date registered
15/09/2009
Date last updated
15/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled study of the effects of oral intake of water inneuroligical disorder dysphagic patients who have been prescribed thickened fluids with consideration to bacterial colonisation and immunological response.
Scientific title
A randomised controlled study of the effects of oral intake of water in neurological disorder dysphagic patients who have been prescribed thickened fluids with consideration to bacterial colonisation and immunological response.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 3874 0
Condition category
Condition code
Neurological 4071 4071 0 0
Other neurological disorders
Neurological 4072 4072 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients prescribed thickened fluids will be able to consume unlimited amounts of thin water for a period of five days that will be provided to them by nursing staff. All fluids other than wter will be thickened. There will be no limit to the amount of thin or thickened water. Participants will already have been prescribed thickened fluids by their treating Speech pathologist.
Intervention code [1] 241244 0
Treatment: Other
Comparator / control treatment
Patients prescribed thickened fluids will not be allowed to consume thin water as per the treatment group. Thickened fluids are any fluids other than water that require to be thickened using a thickening agent of patient choice. Thickened fluids are consumed as per normal unthickened fluids,. therefore, when the patient is thirsty and wants a drink other than water, thickened fluids will be provided over a period of five days.
Control group
Active

Outcomes
Primary outcome [1] 4971 0
To assess quality of life and hydration levels in patients who are prescribed thickened fluids and are allowed acces to water compared with patients who are only able to consume thickened fluids.
Timepoint [1] 4971 0
five days from the placement of the participant onto the study.
Secondary outcome [1] 257445 0
To assess changes in immune function with the provision of thin water.
Timepoint [1] 257445 0
five days from the placement of the participant onto the study.

Eligibility
Key inclusion criteria
Participants who have been prescribed thickened fluids by their treating Speech pAthologist will have the opportunity to be included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients not cleared for the study by a Medical Officer

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
patients must have dysphagia and be precribed thickened fluids. patient must be assessed by a Speech Patholgist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation will not be required during this trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4059 0
Hospital
Name [1] 4059 0
West wimmera health service
Country [1] 4059 0
Australia
Primary sponsor type
Hospital
Name
West wimmera health service
Address
POBOx 231 Nhill VIC 3418
Country
Australia
Secondary sponsor category [1] 3653 0
Hospital
Name [1] 3653 0
peter mac cancer centre
Address [1] 3653 0
1 A'Beckett strett melbourne 3001
Country [1] 3653 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6134 0
Ethics committee address [1] 6134 0
Ethics committee country [1] 6134 0
Date submitted for ethics approval [1] 6134 0
28/11/2009
Approval date [1] 6134 0
Ethics approval number [1] 6134 0

Summary
Brief summary
The purpose of the study is to investigate the effects of thin water in patients who have been prescribed thickened fluids. The hypothesis is that there will be no ill effects and that quality of life will be improved as aresult of the provision of thin water to patients with dysphagia who have been prescribed thickened fluids.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29072 0
Address 29072 0
Country 29072 0
Phone 29072 0
Fax 29072 0
Email 29072 0
Contact person for public queries
Name 12229 0
Martha Karagiannis
Address 12229 0
POBOX 231 NHILL VIC 3418
Country 12229 0
Australia
Phone 12229 0
+61 3 53914222
Fax 12229 0
Email 12229 0
[email protected]
Contact person for scientific queries
Name 3157 0
Martha Karagiannis
Address 3157 0
POBOX 231 NHILL VIC 3418
Country 3157 0
Australia
Phone 3157 0
+61 3 53914222
Fax 3157 0
Email 3157 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.