Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05744245 |
| Other study ID # |
22043 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2023 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
December 2022 |
| Source |
University of Nottingham |
| Contact |
Jacqueline Benfield, PhD |
| Phone |
07738017966 |
| Email |
jacqueline.benfield1[@]nottingham.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
About 50% of people who have a stroke experience difficulty swallowing. There is a growing
evidence base showing that swallowing therapy can help to improve swallowing, but we don't
know which type or how much therapy is most beneficial. The investigators are further
developing one particular intervention - swallow strength and skill training with
biofeedback. This involves practicing strong or effortful swallows and practicing controlling
the timing of swallowing using visual feedback on a screen showing the activity of the
muscles involved in swallowing. The investigators want to know whether trained clinicians are
able to deliver this therapy in acute hospital settings early after stroke. The investigators
also want to explore whether there is an effect of dose in improving swallowing and other
health factors. To do this the investigators will conduct a trial across several stroke units
in the east midlands. The study aims to recruit 120 participants who have had a stroke and
have dysphagia and who will randomly be placed in one of three groups. One group will get a
standard dose therapy (10 x 35 minute sessions over 2 weeks), another group with receive a
high dose therapy (20 x 35 minute sessions over 2 weeks) and the third will receive 'usual
care' which is what they would usually get from their current service. The investigators will
look at what therapy participants actually get, what factors might influence this and the
training, support and conditions that enable clinicians to deliver the therapy. The
investigators will also assess the participants swallowing and collect information on their
health, face to face at the beginning and after the therapy and over the phone at three
months.
Description:
A PPI group of people or carers of people who have post stroke swallowing difficulties have
been convened and consulted regarding the methodology. They have helped to decide which
swallowing outcome measures should be collected at which time points. They have reviewed and
fed back on the participant information sheets and are helping to decide on which format of
visual biofeedback is best for the therapy sessions. A group pf stakeholder SLTs and SLTAs
are helping to design the training and materials to be used to train up clinicians to deliver
the intervention as part of this trial.
Recruitment The clinical trial will be carried out in the stroke units of three East Midlands
services. The study aims to recruit 120 patients. Patients who have had a stroke will be
screened for initial eligibility by clinical teams. Eligible patients will be given verbal
and written information about the study. Extra time will be given to patients who have
cognitive/communication difficulties to support their understanding of the research. Patients
will be given up to 24 hours to talk to their families and decide whether they want to
participate. If they indicate they want to participate the researcher will assess their
capacity to consent and ask them to complete a consent form. If a patient does not have the
capacity to consent advice will be sought from their next of kin about whether they think the
patient might have wanted to be involved.
Eligibility screen Once consent is given, study participants will have a further eligibility
screen by one of the clinical Speech and Language Therapists to see whether they have the
visual, communication, cognitive and swallowing ability to be able to complete the
intervention. Electrodes will be placed on the muscles underneath the participants' chin and
connected to a laptop via an sEMG device, participants will be asked to swallow and track the
signal their swallowing makes on the screen, if they can do this they will be eligible to
participate. Information about the participants health, stroke and demographics will be
collected to explore reasons why some patients are not able to complete the intervention to
help with eligibility criteria in the future. No further data will be collected for those who
fail the screen.
Baseline measures Measures of swallowing strength and skill will be recorded for participants
who pass the eligibility screen, this involves producing a number of regular and strong
(effortful) swallows. Further baseline measures will be collected by research nurses
including their current swallow severity, stroke severity, quality of life etc.
Randomisation Once collected, key information about participants age, stroke & swallow
severity as well as which site they are recruited from will be entered into an online secure
research database which will randomly assign them to one of three treatment groups.
Treatment
Treatment period will be 2 weeks and the intervention the patient receives is dependent the
group they are in:
Standard dose of swallowing therapy ST1 - Up to 10 sessions of 1:1 therapy over a 2 week
period. These 10 sessions are up to 35 minutes each. Therapy will be given at bedside. Where
possible with patients sitting out in a chair and with a table in front of them. Patients
will be set up with electrodes under their chin and a laptop in front of them. They will be
asked to do a series of swallows - increasing the intensity and controlling the timing of
their swallowing. Under instruction they will use the visual information on the screen and
SLT feedback so they know when they are achieving the targets laid out. They will practice
with swallowing their own saliva and there are breaks so they can have a drink or mouthcare
if they are nil by mouth. These patients will also receive usual care from the SLTs managing
them on the ward - see Control group for details.
High dose of swallowing therapy ST2 - this is the same as ST1 except that patients will
receive two 35 minute sessions per day, so 20 in total.
Control group - All the patients, including the control group will receive usual care. This
means the care that the SLTs usually give to patients on the ward. This might include swallow
reviews every 2-7 days, trials of small amounts of oral intake where possible and/or
swallowing exercises. These exercises are sometimes given to the patient to complete in their
own time.
Data collection during and after the treatment period During the treatment - The number,
length and content of sessions will be recorded. Details of what usual care entails will be
recorded. Any adverse events will be recorded.
Post therapy outcome measures - This will be carried out by a blinded researcher who does not
know which treatment group the patient is in.
2 week measures - within 4 days of the end of intervention the same assessments
/questionnaires/checklists will be carried out as at the beginning. Information from
participants medical notes relating to their health, and swallowing will be collected. If the
participant is unable to answer the questions themselves their relatives/NOK will be asked
where appropriate.
Discharge measures - When participants are discharged from hospital the researchers will
collect the date and location and summarise the support they have had with any ongoing
swallowing impairment from the notes. A diary will be sent to participants to help them keep
track of ongoing support they receive with regards to their swallowing up to 90 days after
getting involved in the research.
Day 90 measures - A researcher will phone the participant at their home, residence or
rehabilitation facility and repeat the questionnaire/checklist based measures around
swallowing, health and quality of life. Participants will also be asked about what support
from services they have received since leaving hospital and whether the diary has helped to
collect this information. If the patient is unable to answer the questions themselves their
relatives/NOK/carers will be asked where appropriate.
From 12-24 months in to the clinical trial the clinical teams who are delivering the
intervention will be contacted and asked to participate in interviews and or observations to
find out about how the intervention is being delivered. A support log will also be kept by
the trial coordination centre, recording any requests for support from clinicians who have
been trained to deliver the intervention. Observation sessions with clinicians delivering
intervention at 3 sites (6 in total). During one of the treatment sessions a researcher will
observe the clinician carrying out the intervention. A fidelity checklist will be used by the
researcher to record how well the therapy patients actually get compares with the core
components of the intervention.
Interviews with clinicians who delivered the intervention, 4 at each site (12 in total).
Interviews will be carried out via Teams and questions will semi-structured and iterative
(questions may need to change based on themes that come out from previous interviews) - see
attachments for Interview Topic Guide - informed by the Conceptual Framework for Intervention
Fidelity (CFIF) & Conceptual Framework for Implementation Research (CFIR). Interviews will be
recorded and transcribed with no identifying information and saved on the UoN research drive.
Participant information sheets will be given to clinicians involved in delivering the
intervention. Consent will be gained by clinicians before observations/interviews. After 120
patients have been recruited or after 24 months the data will be analysed and written up and
conference abstracts & papers will be prepared for dissemination of findings.
