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PhEAST trial

Pharyngeal Electrical Stimulation for Acute Stroke dysphagia Trial

Trial documents

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Minor amendments

Minor amendments

MA-29-24

  1. Change of PI at Leighton Hospital, Crewe.

MA-28-24

  1. Change of PI at King's Mill Hospital, Mansfield.

MA-27-24

  1. Addition of one NHS recruiting centre (Forth Valley Royal Hospital).

MA-26-24

  1. The recruitment period for PhEAST has been extended to 31/03/2025.

MA-25-24

  1. Addition of Royal Surrey County Hospital.
  2. Addition of Aintree Hospital.

MA-24-24

  1. Addition of Eastbourne Hospital.
  2. Addition of Queen Elizabeth Hospital Gateshead
  3. Addition of St. Peter's Hospital
  4. Withdrawal of Torbay Hospital.
  5. Withdrawal of Royal Stoke University Hospital.

MA-23-24

  1. 1. Change of PI at two recruiting sites.
  2. 2. Withdrawal from one site in set-up.

MA-22-23

MA-21-23

  1. The following sites will be added as recruiting sites in the PhEAST study: 1) Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust, PI: Helen Day. 2) Darent Valley Hospital, Dartford and Gravesham NHS Trust, PI: Prasanna Aghoram. 3) East Surrey Hospital, Surrey and Sussex Healthcare NHS Trust, PI: Zoe Maylon.

MA-20-23

MA-19-23

  1. This non-notifiable amendment comprises of the fixing of a typographical error within the Scottish legal representative information sheet. Footer stated Version 5.0, should have stated version 6.0

MA-18-23

  1. This amendment comprises of the change of PI at one site (West Suffolk Hospital).
  2. It also comprises of some wording changes to clarify follow up information within the postal follow up for days 90, 180 and 365.

MA-17-23

  1. This amendment comprises of the addition of new sites that will be partaking in the PhEAST trial, and the change in PI at a participating site.

MA-16-23

  1. This amendment comprises of the addition of two new sites.
  2. It also includes the addition of the collection of discharge medication, which comes under health resource use within the trial protocol.

MA-15-23

  1. This amendment comprises of the provision of certain scales in large print to assist participants who may have communication difficulties.

MA-14-23

  1. The non-commercial agreement has been updated to the UoN version based on the mNCA 2022.

MA-13-23

  1. This amendment comprises of the addition of two new sites and the change of PI at one site.

MA-12-23

  1. This amendment updates the formatting of the 3, 6 and 12 month postal follow up

MA-11-23

  1. This amendment comprises of adding a sentence / changing a sentence in each patient facing document for Scotland, to state explicity that we will collect the CHI number of each participant.
  2. It also adds some information to the legal representative information sheet about being an informant, and changes the informant consent forms by removing the part which said we collected dates of birth for informants. There is also clarification added to each information sheet that data may be used from IDS Scotland / EDRIS.

MA-09-23

  1. This amendment comprises of the change of PI at Southampton.

MA-08-23

  1. This amendment comprises of the addition of a new site that will run the PhEAST trial (Salford Royal Hospital).

MA-07-22

  1. This amendment comprises of the addition of two new sites to the PhEAST trial.

MA-06-22

  1. This amendment comprises of the change of a typographical error in the consultee declaration form, and a typographical error in the two new appendices (M & N).

MA-05-22

  1. This amendment comprises of the addition of a new site , and removal of sites no longer able to participate in the PhEAST trial.

MA-04-22

  1. This amendment comprises of the addition of a new site , and removal of sites no longer able to participate in the PhEAST trial.

MA-03-22

  1. Changes to PIs / sites.

MA-02-22

  1. Addition / change to PIs and sites.

MA-01-22

  1. Addition of PIs and changes to sites.


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