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CompletedNCT03700853Updated Oct 29, 2020

Validation and Reliability Testing of Dysphagia Trained Nurse Assessment

An observational study in Dysphagia Following Cerebral Infarction and Dysphagia Following Nontraumatic Intracerebral Hemorrhage, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-29.

Sponsored by University of Nottingham · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
47
Ages
18 Years and older
Sex
All
01

Study summary

Nurses at Royal Derby Hospital, UK have been trained to use a comprehensive protocol based dysphagia assessment (Dysphagia Trained Nurse Assessment (DTNAx)) to assess all acute stroke patients on admission. This study aims to validate the tool by comparing it to the gold standard assessment - Videofluoroscopy and usual assessment by a Speech and Language Therapist. Inter-rater and intra-rater reliability will also be tested by comparing the assessment results of two different nurses or the same nurse.

Read the detailed description

Speech and Language Therapists (SLTs) at Royal Derby Hospital (RDH) have developed a tool that trained nurses can use to carry out swallowing assessments with patients following a stroke. It consists of checks to ensure the patient is alert/well enough, checks any abnormalities in the muscles of the mouth or throat and trials different types of foods/drinks. If they 'pass' the assessment patients are started with regular diet and fluids. If they have dysphagia the nurses can recommend modified foods/drinks if they have found to be safe during the assessment. If the patients 'fail' with all trials - they remain nil by mouth. Around 50% of patients who have a stroke have difficulties swallowing (dysphagia). If dysphagia is identified early it reduces secondary complications such as pneumonia. There are no similar tools in the UK that have been tested to check they are doing what they say they are doing (validity) or the results are the same no matter which trained nurse uses the tool (reliability). This study aims to test the validity and reliability of the Dysphagia Trained Nurse Assessment DTNAx that is currently used in the acute stroke pathway at RDH.

Over an 18 month period we aim to recruit 50 patients admitted to RDH with a new stroke and who have had an initial DTNAx. The results of the DTNAx will be compared to the gold standard dysphagia assessment - videofluoroscopy - a video xray of swallowing and also compared to the usual SLT assessment. We can calculate whether the tool identifies dysphagia and whether the recommendations made by using the tool are accurate and safe. To test reliability - the DTNAx will be repeated by the same nurse or by a different nurse. The patients will be involved in the study for approximately 24 hours.

02

Conditions studied

  • Dysphagia Following Cerebral Infarction
  • Dysphagia Following Nontraumatic Intracerebral Hemorrhage
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 47 is below the median of 97 across 207 observational studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults over 18 who have been admitted to the Acute Stroke Unit who have a clinical diagnosis of stroke, who have had a DTNAx. They are medically stable, able to sit out in a suitable chair and have no previous dysphagia

Inclusion criteria

  • Adults ≥ 18
  • Clinical diagnosis of stroke (ischaemic or haemorrhagic)

Exclusion criteria

Exclusion Criteria:

  • Dysphagia of another cause
  • Unable to tolerate VFS due to agitation or severe cognitive difficulties (patients need to be able to sit in a suitable chair - REA assist, 9L, Mangar Porter, Tilt and Space etc. for VFS)
  • Not medically well enough to undertake assessments (as determined by the clinical care team)
  • Pregnant women
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
47 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testDysphagia Trained Nurse Assessment (DTNAx)

    Bedside swallowing assessment carried out by trained nurses

06

What researchers measure

Primary outcomes

  1. Evidence of dysphagia on gold standard test

    Cut off scores as per Standardised and reliability assessment: Modified Barium Swallow Impairment Profile on Videofluoroscopy assessment

    Time frame: 24 hours

  2. Fluid Recommendation on gold standard test

    On Videofluoroscopy - Least restrictive fluid with Penetration Aspiration Scale of 1 or 2, MBSImP pharyngeal residue rating of \<3, number of swallows \< 3.

    Time frame: 24 hours

  3. Diet Recommendation on gold standard test

    On Videofluoroscopy - Least restrictive fluid with Penetration Aspiration Scale of 1 or 2, MBSImP pharyngeal residue rating of \<3, number of swallows \< 3. • If solid bolus trialled (forkmashable/normal) - mastication needs to be timely and complete - therefore MBS-Imp score on Component 3 Bolus preparation/mastication = 0

    Time frame: 24 hours

Secondary outcomes

  1. Outcome of SLT clinical bedside assessment (SLTAx)

    This is not a standardised test - but it is usual practice. Information will be collected on the subtest carried out in the assessment. Ultimately the outcomes that are measured are SLT judgement of: presence of dysphagia, safe diet recommendation, safe fluid recommendation

    Time frame: 24 hours

  2. Outcome of 2nd Dysphagia Trained Nurse Assessment (DTNAx)

    The DTNAx standardised assessment and is the assessment that is being validated in this study. To measure intra and inter rater reliability this outcome measure is the outcome of a second DTNAx assessment - specifically the safe diet recommendation and safe fluid recommendation.

    Time frame: 24 hours

07

Study locations

1 site
  • Royal Derby Hospital
    Derby, Derbyshire DE22 3NE, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03700853
Lead sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
Responsible party
Sponsor
First posted
Oct 9, 2018
Start date
Dec 1, 2017
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Last update
Oct 29, 2020

Study contacts

Timothy England
principal investigator · University of Nottingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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