Condition category
Signs and Symptoms
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
27/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Timothy Hendra

ORCID ID

Contact details

STH NHS Foundation Trust
Geriatric Medicine
Q Floor
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
+44 0114 226 6419

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes