Dysphagia Following Cerebral InfarctionNCT03700853
Validation and Reliability Testing of Dysphagia Trained Nurse Assessment
An observational study of Dysphagia Following Cerebral Infarction and Dysphagia Following Nontraumatic Intracerebral Hemorrhage, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia Following Cerebral Infarction, Dysphagia Following Nontraumatic Intracerebral Hemorrhage
- What is being tested?
- Dysphagia Trained Nurse Assessment (DTNAx)
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2017to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Adults ≥ 18
- Clinical diagnosis of stroke (ischaemic or haemorrhagic)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity And Reliability Of A Dysphagia Trained Nurse Assessment (DTNAx) Tool In Acute Stroke
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.
- Conditions
- Dysphagia Following Cerebral Infarction, Dysphagia Following Nontraumatic Intracerebral Hemorrhage
- Being tested
- Dysphagia Trained Nurse Assessment (DTNAx)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysphagia Trained Nurse Assessment (DTNAx)Diagnostic test
Bedside swallowing assessment carried out by trained nurses
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of dysphagia on gold standard test
Cut off scores as per Standardised and reliability assessment: Modified Barium Swallow Impairment Profile on Videofluoroscopy assessment
Measured: 24 hours
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.
Measured: 24 hours
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
Measured: 24 hours
Secondary outcomes (2)
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
Measured: 24 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Dec 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia Following Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Timothy England, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700853
- Sponsor's protocol ID
- 17027
- Status last verified
- Oct 2020
- First submitted
- 24 Sep 2018
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity And Reliability Of A Dysphagia Trained Nurse Assessment (DTNAx) Tool In Acute Stroke
- ClinicalTrials.gov ID
- NCT03700853
- Acronym / sponsor ID
- 17027
- Conditions
- Dysphagia Following Cerebral Infarction, Dysphagia Following Nontraumatic Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Adults ≥ 18
- Clinical diagnosis of stroke (ischaemic or haemorrhagic)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dysphagia Trained Nurse Assessment (DTNAx)Bedside swallowing assessment carried out by trained nurses | Diagnostic test | – |
Primary outcome
Evidence of dysphagia on gold standard test
Time frame: 24 hours
Cut off scores as per Standardised and reliability assessment: Modified Barium Swallow Impairment Profile on Videofluoroscopy assessment
Fluid Recommendation on gold standard test
Time frame: 24 hours
On Videofluoroscopy - Least restrictive fluid with Penetration Aspiration Scale of 1 or 2, MBSImP pharyngeal residue rating of <3, number of swallows < 3.
Diet Recommendation on gold standard test
Time frame: 24 hours
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
2 secondary outcomes
Outcome of SLT clinical bedside assessment (SLTAx)
Time frame: 24 hours
Outcome of 2nd Dysphagia Trained Nurse Assessment (DTNAx)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy England principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia Following Cerebral Infarction and Dysphagia Following Nontraumatic Intracerebral Hemorrhage, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of dysphagia on gold standard test (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.