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PhEAST trial – Pharyngeal Electrical Stimulation for Acute Stroke dysphagia Trial

Trial documents

Substantial amendments

 

Substantial amendments

 

SA/11/24

  1. Addition of a new Sponsor legal representative, Veranex.
 

SA/10/24

  1. The introduction of five patient-facing dysphasia/aphasia-friendly resources.
  2. An amendment to the protocol, regarding changes to the inclusion and exclusion criteria, as well as changes to the number of trial catheters permitted per-participant.
 

SA/09/23

 

SA/08/23

 

SA/07/23

  1. This amendment changes the inclusion criteria, to include FOIS 3 for the whole enrolment period.
  2. It also introduces independent physician consultees, whereby a personal consultee cannot be appointed.
  3. The protocol and consultee information sheet and consultee declaration form has been updated to reflect this.
  4. There are then a few minor wording / clarification changes within the protocol.
 

SA/06/22

The main changes in this amendment are changes to the inclusion / exclusion criteria, comprising of:
  1. Inclusion criteria updated to state FOIS score of:  or 3 if 14-31 days post stroke (tube dependent with consistent oral intake of food or liquids)
  2. Exclusion criteria updated to state:  Ongoing treatment of dysphagia with other forms of electrical / magnetic stimulation e.g. NMES, TCDS, rTMS,  Pacemaker, cochlear implant or implantable cardioverter-defibrillator, palliative care.
There are then a number of additional wording changes throughout the protocol for clarification.
  1. The consultee information sheet has had a typographical error changed.
  2. The postal follow up form (day 90, 180 and day 365) has been updated to correspond with the E-CRF.
  3. We have introduced an IQCODE postal form for informants to complete.
 

SA/05/22

  1. This amendment follows the ethical approval for SA_04_22 by the Essex REC for the PhEAST trial. This amendment will update the patient facing information sheets for Scottish sites to reflect the changes made in SA_04_22.
  2. This amendment also adds an informant consent form to accompany the informant information sheet introduced in SA_03_22
  3. This amendment also updates the GP letter with the additional follow up introduced in SA_02_22.
 

SA/04/22

  1. This amendment introduces that participants in the PhEAST trial may need additional chest X-Rays performed, if they are randomised to the PES treatment.
  2. This has been been given radiation assurance by the HRA, having had a CRE and an MPE review the new documents to ensure the correct risk assessment statements are in place.
  3. Further to this, this amendment introduces the collection of protocol deviations, and some additional sentences for clarifcation regarding threshold levels, and the use of catheters.
 

SA/03/22

  1. This amendment follows the ethical approval for SA_02_22 by the Essex REC for the PhEAST trial.
  2. This amendment will update all of the patient facing documents for Scottish sites to reflect the changes made in SA_02_22.
  3. This amendment also adds an aphasia friendly information sheet and consent form, and an informant information sheet and consent form.
 

SA/02/22

  1. This amendment comprises of the addition of a cognitive sub-study, which introduces further follow up time points at day 180 and day 365, with cognitive scales being used at each follow up point, as well as the scales being used previously in the trial protocol.
  2. The day 7 follow up has also been removed as this data will be collected after treatment on days 1-6.
  3. This amendment also comprises various administrative changes, such as wording changes and sentences added for clarification.
  4. Appendix M has been added to outline the cognition sub study scales, and appendix N has been added to outline the IQCODE scale.
  5. All patient facing documents (information sheets, consent forms and GP letter) have been updated with the follow up time points, and cognition has been added in as a follow up measure.
  6. This amendment will also add a postal follow up, should we not be able to contact a participant by telephone to complete the follow up. Finally, this amendment introduces an informant information sheet and consent form, as well as an aphasia friendly information sheet and consent form.
 

SA/01/22

  1. This amendment comprises of updates to the inclusion and exclusion criteria, regarding the consciousness levels of potential participants (NIHSS score added for clarification of which participants can be recruited); the disposition of the participant at day 14 primary outcome (participants need to be in treating organisation for this) and a change to the oxygen levels in the exclusion criteria (up to 35 litres deemed safe with the use of PES).
  2. This amendment also comprises of various administrative changes; namely a protocol version table has been added, the WHO ID added to the front page, and sentences throughout the protocol added for clarification.
  3. This amendment also extends the Serious Adverse Event Collection from days 0-7 to days 0-9 to account for the change in the participant treatment schedule, whereby participants can have three days of treatment followed by a 1 or 2 day break, followed by another three days of treatment, to ensure sites that do not operate at weekends can recruit and treat eligible patients.
  4. Finally, an appendix has been added at the behest of the Austrian ethics committee, to outline their consent procedure that will be approved and followed in Austrian sites.


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