Prevention Of Decline in Cognition After Stroke Trial (PODCAST)

Investigator Materials


Urgent Contact Information

The PODCAST Trials Office can be contacted during UK working hours (excluding weekends and public holidays) on: +44 (0)115 823 1770

For urgent medical enquiries related to the trial (including unblinding) or randomisation problems (including website failure requiring manual randomisation), please contact the following emergency mobile numbers in the order shown:

  1. +44 (0)7798 670726
  2. +44 (0)7771 542937
  3. +44 (0)7725 580092

If you have specific questions about the trial, try reviewing the Training PowerPoint presentation and the FAQ page (see immediately below scrolling text).


2015, November: the baseline paper has now been published!

Training Powerpoint presentations

Training presentation, V1.0 (PPT file, 10.6MB)
Frequently Asked Questions (FAQ), v1.1 (pdf)

Tweets by @podcasttrial

Documents

Feel free to download the following PODCAST documents as and when required. The data collection forms may be completed and then faxed to the Trials Office if you are not using the website for entering data. These documents are not designed for use outside the PODCAST trial or by people who are not investigators in the PODCAST trial.

NEW DOCUMENTS

The following are new or updated documents. They can also be found under the headings below but are located here for ease of reference.

None.


All Documents

Papers

Baseline characteristics, analysis plan and report on feasibility for PODCAST (pdf) Trials, 07/11/2015

If you are looking for archived/superseded documents for the purposes of closedown, please visit this page.

Sponsor Standard Operating Procedures (SOPs)

The Sponsor (University of Nottingham) maintains comprehensive 'high-level' generic trial SOPS - please email podcast@nottingham.ac.uk if you need further information. The following are particularly relevant:

Recruitment & consent, v1.0 (TA011) (pdf)
University SOPs: Trial initiation, SAE reporting, GCP breach, TA 008/014/016 versions 2.0/2.0/1.0 (pdf)
Recording a Serious Adverse Event (SAE), v2.0 (TA014) (pdf)

Trial Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)

Flowchart v1.1 (pdf)
Blood collection, version 1.0 (pdf)
Intensive algorithm management: Blood pressure lowering, version 1.0 (pdf)
Intensive algorithm management: Lipid lowering, version 1.0 (pdf)
Question sets: ACE-R/TICS-M, version 1.0 (pdf)
Drug prescribing examples for intensive patients, 8 March 2012 (pdf)
SAE/Outcome categories (link) Log-in to see current categories for use in SAE/Outcome reporting
Closedown, v2.0 (pdf)
Fax: safe haven, 09/04/2008 (pdf) from the University of Nottingham

Data collection and other forms

Screening & enrolment log (RF1 TA011), v1.0 (doc) Form can now be completed electronically
Delegation Log (RF2 TA008), v1.0 (doc) Form can now be completed electronically; delegated duties also attached
Training record form (RF1 TA008), v1.0 (doc) Form can now be completed electronically
File note v1.1 (doc)
File note v1.1 (pdf)
Data correction form v1.2 (pdf)
Expression of interest form, version 1.0 (pdf)
Expression of interest form, version 1.0 (doc)
Fax cover sheet, V2.0 (pdf)
Patient details fax form, V1.3 (pdf)
Patient details fax form, V1.3 (doc)
Informant contact details form, V1.0 (pdf)
Informant contact details form, V1.0 (doc)
eCRF blank forms (link) Either view only in Demo website or log in to PODCAST to fill in for a patient
Freezer log form, V1.0 (pdf)
Transport expenses claim form, v1.1 (pdf)
Trail-making test (Part A) (gif; image file)
Trail-making test (Part B) (gif; image file)

Approved documents

Protocol Version Control (pdf)
Protocol, v1.6 (pdf)
Protocol changes v1.5 - 1.6 (pdf)
Investigator brochure, V 1.0 (pdf file, 2.2MB)
Final letter to participants, 30/04/2014 (pdf)
Consent/Participant: Screening telephone call, version 1.6 (doc)
PIS/Participant: Main study, v1.6 (doc)
PIS/Participant: Substudies - genetics, ABPM, CT; version 1.5 (doc)
PIS/Informant: Main study, v1.2 (doc)
Consent/Participant: Substudies, version 1.5 (doc)
Consent/Participant: Main study, version 1.6 (doc)
Consent/Informant: Main study, version 1.2 (doc)
GP: Patient has agreed to be screened for trial, version 1.5 (pdf)
GP: Patient has agreed to join trial, version 1.6 (pdf)
GP: Briefing letter, V1.6 (pdf)
GP: Patient has dementia, version 1.4 (doc)
GP: Patient has been in trial 1 year, v1.0 (doc)

Supporting documents

Reference

Criteria for inclusion/exclusion (pdf)
Links, v1.1 (pdf), for information

General

UK

MREC approval letter, 31/12/2013 (pdf) Request dated 18/12/2013; minor amendment re: trial end date
Email accompanying above amendment (pdf)
MREC approval letter, 13/08/2013 (pdf) Request dated 25/06/2013; Amendment 6 re: protocol 1.6
MREC application letter, 16/07/2013 (pdf) re: protocol 1.6
MREC approval letter, 13/06/2012 (pdf) Request dated 15/05/2012; Amendment 7/Substantial Amendment 4 re: protocol 1.5
Progress of trial in UK - regulatory and approvals, 9 August 2011 (pdf)
Area Prescribing Committee: Letter of support from Nottinghamshire, 24 February 2010 (pdf)
Funding: Alzheimer's Society, 05 February 2009 (pdf)
Funding: The Stroke Association, 29 January 2009 (pdf)
Insurance cover letter for UK 1 Aug 2014 - 31 July 2015, dated 29/07/2014 (pdf) Previous insurances have moved to archived documents page.
ISTRCTN: Assignment of trial number, 23 September 2009 (pdf)
MHRA: Confirmation that no Clinical Trials Authorisation (CTA) required, 27 April 2009 (pdf)
NRES: Amendment 6 minor, 20 July 2011 (pdf)
NRES: Application letter, 13 July 2011 (pdf)
NRES: Amendment 5, 19 May 2011 (pdf)
NRES: Application letter, 26 April 2011 (pdf)
NRES: Application form, 26 April 2011 (pdf)
NRES: Amendment 2 reissue, 14 September 2010 (pdf)
NRES: Amendment 2, 14 September 2010 (pdf)
NRES: Application, 9 August 2010 (pdf)
NRES: Application, 23 July 2010 (pdf)
NRES: Amendment 1, 7 June 2010 (pdf)
NRES: Final approval, 12 November 2009 (pdf)
NRES: Trial response to provisional approval by Nottingham REC, 13 October 2009 (pdf)
NRES: Confirmation that Adults with Incapacity (Scotland) Act 2000 does not apply, 28 September 2009 (pdf)
NRES: Provisional approval subject to a number of issues being clarified, 21 September 2009 (pdf)
NRES: Application form signatures, 24 July 2009 (pdf)
NRES: Application form, 24 July 2009 (pdf)
NRES: Application letter, 24 July 2009 (pdf)
IRAS R+D: Application form, 10 August 2009 (pdf)
NUH: Nottingham University Hospitals NHS Trust approval, 14 April 2010 (pdf)
SHA: Letter of support from East Midlands, 22 February 2010 (pdf)
Sponsor/UoN: University of Nottingham, 27 July 2009 (pdf)

Teleconference Workshops

UK teleconference, 11 June 2014 (pdf)
UK teleconference, 13 September 2012 (pdf)
UK teleconference, 18 April 2012 (pdf)
UK teleconference, 23 November 2011 (pdf)
UK teleconference, 11 August 2011 (pdf)

Data Monitoring Ethics Committee

2014 May (pdf)
2013 August (pdf)
2013 May (pdf)
Independent Data Monitoring Committee Charter, v1.1 (pdf)

Training Documents and Files

Addenbrooke's Cognitive Examination, ACE (wmv, 86 MB) Copyright University of Manchester/Alistair Burns
Addenbrooke's Cognitive Examination, ACE-R guide to scoring (pdf) Copyright John Hodges 2000
Stroop test demonstration (link) Copyright University of Nottingham/Philip Bath
IQ Code Interview (m4v/MPEG, 54.4.MB) Copyright University of Newcastle/Gary Ford
IQ Code Interview (MOV/QuickTime file, 66.6 MB) Copyright University of Newcastle/Gary Ford
Further files to be uploaded as available


Publications

The following files describe studies underpinning the rationale for performing PODCAST. These are for the local use of investigators; please do not distribute the files since their copyright is held by the publishers in some cases.

Post stroke cognitive impairment & dementia, review (pdf)

Powerpoint presentations

UK Investigator meeting - Nottingham, 17-18 April 2013 (ppt, 37Mb) This file is very large: it may take up to 3mins to download on a broadband connection
Training presentation, V1.0 (PPT file, 10.6MB)

Demo/practice website and database

Demo / practice website

For International Coordinating Centre / Nottingham Trial Office

University of Nottingham 'high level' SOPs (link) only available within UoN intranet

Contact details

Contact information, V3.1 (pdf)

PODCAST Trial Office
Stroke, Division of Clinical Neuroscience
University of Nottingham
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
UK
 
Telephone: 0115 823 1770
Fax: 0115 823 1771
E-mail: podcast@nottingham.ac.uk

Written by Philip Bath, last updated by Dawn Hazle 9th November 2015

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