Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0059182017
Study information
Scientific title
Acronym
Study hypothesis
Do dysphagic stroke patients managed with thickened fluids have outcomes which are equally as good as patients managed with other SLT treatment strategies?
Ethics approval
Added May 2008:
North Sheffield Local Research Ethics Committee. Date approved 19/4/06. REC No 06/Q2308/33.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke patients presenting with dysphagia
Intervention
Thickened fluids vs swallowing / postural modifications
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Added May 2008:
1. Number and frequency of chest infections
2. Episodes of dehydration
Secondary outcome measures
Added May 2008:
Patient and carer compliance with interventions
Overall trial start date
01/12/2005
Overall trial end date
01/03/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Patients admitted to Sheffield Teaching Hospitals with a diagnosis of stroke who are referred to Speech & Language Therapy Dept with a diagnosis of dysphagia.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
Added May 2008:
Adults presenting with moderate or severe dysphasia
Recruitment start date
01/12/2005
Recruitment end date
01/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
STH NHS Foundation Trust
Sheffield
S10 2JF
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary