Summaries of the trial:

LoTS care Newsletters:


This trial has been approved by the Leeds (West) Research Ethics Committee.
Reference number: 08/H1307/43

International Standard Randomised Controlled Trial Number (ISRCTN): 67932305

This study has been adopted by the UK Stroke Research Network (UKSRN).

This trial is being sponsored by the Bradford Teaching Hospitals NHS Foundation Trust.

This trial is funded as part of a National Institute for Health Research (NIHR) Programme Grant for Applied Research and by The Stroke Association

This trial is being conducted in collaboration with the Clinical Trials Research Unit (CTRU).

the stroke association the stroke association

 

Researcher Frequently Asked Questions

Thank you for all your help with the LoTS care trial 

1. SCREENING
2. ELIGIBILITY
3. CONSENTS
4. CRFs & QUESTIONNAIRES
5. REGISTRATION
6. AFTER REGISTRATION

1. SCREENING

Do I screen everyone who has had a stroke?
No. Please only screen patients who are referred to the participating community stroke care co-ordinator (SCC) / community team. We only need to collect data on patients referred to the SCC rather than everyone on the Stroke Unit. We hope this will be less of a burden for you. Please liaise with the acute clinical team and/or the SCC to find out which patients have been referred to the community service.

Can I make copies of the screening log?
No, the screening log booklet is designed so that the details of one patient are completed on each page and each page has a unique pre-printed screening number on it. For this reason, please do not photocopy the screening log booklet; when you are close to completing a booklet, please contact Andrew Carter at the CTRU who can send you another one. 

 

2. ELIGIBILITY

Does the patient need to have a carer to be considered for the trial?
No, a patient can participate in the trial without a carer. If however there is a carer available who fulfils the eligibility criteria and they would like to participate please also approach the carer to take part.

 

3. CONSENT

What do I do if the patient is unable to consent for themselves?
If the patient cannot understand the study please obtain consultee assent from a relative/friend (Welfare Guardian / Nearest Relative consent in Scotland). The consultee will need to consider the patient's beliefs and interests and any advance decisions made by the patient must take precedence.
Please use the separate consultee information sheet and assent form (or Welfare Guardian / Nearest Relative information sheet and consent form in Scotland).

What do I do if the patient is struggling to sign the consent form?
If a patient has capacity they should consent to the trial for themselves and sign the consent form wherever possible. If you are confident that the patient understands the information sheet and consent form but they are struggling to sign the consent form please ask the patient to make a mark on the signature line of the consent form the best that they can. In this case please ask an independent witness (member of the clinical team) to be present during the consent process and ask them to countersign the patient's signature. Please also complete a file note to explain why a countersign was required and who the independent witness was. Please return a copy of the file note with the consent form to the CTRU so that the trial team have a clear picture of the consent process. This witness consent procedure should also be used for patients who are unable to read.

Therefore if the patient has capacity it is necessary that the patient provides consent for themselves even if they are unable to sign the consent form. If the patient does however lack capacity please use the consultee information sheet and assent form as mentioned above.

 

4. CRFs & QUESTIONNAIRES

Does the patient need a certain score in the 6CIT before I can consider them?
No, we would like to collect this data as a measure of the patient's cognitive impairment for information only.

What do I do if the patient cannot complete the questionnaire themselves?
If the patient cannot read or tick the boxes of the questionnaire then their relative or friend can help by reading the questions / ticking the answers for them but the answers must be the patient’s own.

If the patient cannot understand the questionnaire or express their answers then their relative/friend can complete the questionnaire entirely on the patient's behalf, answering the questions as they believe the patient would.

We ask within the questionnaire whether the patient completed the questionnaire themselves or whether they had any help, and if they did receive some help, the nature of this assistance. We will therefore be aware of how the questionnaire was completed in the analysis.

Can I help a patient to complete the questionnaire?
Please leave the questionnaire with the patient to complete on their own or with the assistance of their relative/friend. We would like the person completing the questionnaires to be consistent so that the questions are interpreted the same way at baseline and at follow-up.

You can help the patient complete the economic section of the questionnaire (pages 9-18).

We realise that in some circumstances a patient may have physical difficulties making it difficult for them to tick the questionnaire themselves and their relative / friend may not be available at the time to help. In these situations, as a last resort, you can also assist with sections 1-4 by ticking the patient's responses to the questions; however the answers must the patient’s own. The questionnaire is not intended to be completed in an interview format and we would like the interpretation of the questions to be the same at baseline and follow-up. Please ensure there is someone to help at the follow-up points.

 

5. REGISTRATION
What needs to be done before I can register a patient?
You should have taken consent from the patient (and carer), completed your baseline CRF and ensured the patient (and carer) have completed their questionnaire(s) before you register the patient into the study.

What if I take consent but the patient/carer doesn’t complete their questionnaire?
Please don’t register them into the study. Keep a copy of the consent and any data you may have collected in the site file and record the reason why you haven’t registered them on the patient’s screening log.

What if I take consent but then the patient becomes ineligible for the study?
Please don’t register them into the study. The patient needs to fulfil all of the eligibility criteria at the time of registration. Keep a copy of the consent and any data you may have collected in the site file and record the reason why you haven’t registered them on the patient’s screening log.

If I recruit a patient from the community which centre code do I use?
Consent/assent defines a patient's entry to the trial. Therefore the site of consent should be used to define which centre number is used. If a patient is consented in hospital and the recruitment process is completed in a patient's home please use the hospital centre number. If the patient consents at home please use the PCT centre number.

If I am approved to recruit patients at more than one site does it matter which centre code I use?
Yes, please ensure you use the appropriate centre code for the site from which you are recruiting the patient. Your PIN and Authorisation codes are linked to a centre code, if there is a discrepancy between the centre code used and the centre(s) we have listed for you, the 24-Hour telephone registration system will not work.  In addition, if you are recruiting for more than one service please ensure you enter the correct service code.

What do I do if I lose my PIN and Authorisation code? 
Please contact Alison Fergusson or Andrew Carter at the CTRU who will be able to reissue the codes.

Is it OK for me to use a colleague’s PIN and Authorisation code?
No.  PIN and Authorisation codes are linked to your name.  If there is a discrepancy between what is detailed on the 24-Hour Registration System and the data from the CRFs to be entered on to the database, data queries will be generated.

Where can I access a copy of the phonetic alphabet for recording a patient’s initials?
It is a great help if you can use the phonetic alphabet when you speak the patient’s initials on the telephone registration system. A list of the phonetic alphabet is included in the Registration Work Instruction, which is provided in section 14 of your Site File.

 

6. AFTER REGISTRATION

What do I send to the GP?
Once you have registered a patient to the trial please send the following to the GP:
- GP letter, please pp this on Anne Forster’s behalf
- GP trial summary
- Relevant information sheet
- Copy of the consent / assent form

What do I need to send back to the CTRU?
Please send the top copy of the CRFs back to the CTRU. Please send the contact details CRF (Form 08) and consent forms back in a separate envelope to the remainder of the CRFs.  Please also make a photocopy of the questionnaire(s) and return the original back to the CTRU. We realise it is tedious to photocopy the questionnaire packs however we would hate for you to go to all the time and effort of recruiting a patient and then for the baseline questionnaire to go missing in the post with no backup available.

When should I send the CRFs back?
It would be great if you could send back the CRFs to the CTRU as soon as you can after registering a patient. Please send the clinical CRFs in one envelope and the contact details CRF and consent form together in another envelope. If you don't know the discharge date yet, you will need to add this when it becomes known, please hold onto the CRFs until you can add this detail.

Do we have to send out the follow up questionnaires at 6 & 12 months?
No, the CTRU will send out the 6 and 12 month follow-up questionnaires.

What would happen if a patient becomes ineligible after they are registered to the trial?
The LoTS care trial follows the intention to treat principle; therefore the patient would remain in the study. After registration a patient would only be withdrawn from the trial at the patient's request.

What would happen if a carer becomes ineligible after they are registered to the trial?
As described above for a patient, a carer would only be withdrawn from the trial at the carer’s request. Please note that a carer would be withdrawn if their patient dies.

If you have any other queries please contact:

  1. Katie Chapman (for research queries) katie.chapman@bthft.nhs.uk  01274 383407
  2. Alison Fergusson (for any data queries) A.Fergusson@leeds.ac.uk  0113 34 37589

 

Thank you for all your help with the LoTS care trial

  

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