Frequently asked questions.
1) How long will the project last?
Currently, the project is intended to run until December 2012.
2) Are there any funds to support
our participation in the project?
There are no extra funds for clinics who chose to participate as the study
should not require additional staff to deliver the intervention rather
it requires staff to deliver diabetes education in a different way. Support
with recruitment, obtaining informed consent and data collection (questionnaires)
is provided by researchers from the central research team.
We recommend that you contact your Trust R&D Manager to discuss whether
or not they offer funds to support research. The Medicines for Children
Research Network (MCRN - see www.mcrn.org.uk) and the Diabetes Research
Network (DRN - see www.ukdrn.org) may also be able to help.
3) If we are in the control arm can
we still take part in other trials?
No. The CASCADE study is a cluster randomised controlled trial. Clinics
will be randomised to the intervention or control arm after individual
young people have been recruited to the study. In order to fully understand
the effects of the CASCADE intervention it is very important that we compare
it to treatment/practice as usual. Clinics participating in the control
arm of the study are an equally vital part of the trial.
4) Who is eligible to participate?
As with any study there are criteria that patients must meet before they
can be recruited. You will be asked to use the following criteria to determine
a patient's eligibility:
INCLUSION CRITERIA- Include patient if ALL apply
- Diagnosis of type 1 diabetes
- Aged 8-16
- HbA1c of 8.5 or above (defined as mean HbA1c over the last 12 month)
- Under the care of a paediatric and/or adolescent diabetes clinic
(defined as clinic specific for paediatric and/or adolescent diabetes
conducted by a specialist, or general paediatrician with an interest
- Diagnosis made at least 12 months prior
EXCLUSION CRITERIA- Exclude patient if ANY apply
- Significant mental health problems unrelated to diabetes that require
specific mental health treatment
Significant other chronic illness in addition to diabetes that may confound
the results of the intervention
[Patients with coeliac disease or hyperthyroidism are eligible]
Significant learning disability or command of English insufficient to
enable full participation in the planned intervention. Young people with
good command of English but whose parents have poor command of English
will be eligible to attend by themselves if they wish as long as parents
have given informed consent. Another relative who is one of the primary
diabetes carers (e.g. sibling, aunt or uncle) who has good command of
English may participate instead of the parents.
Participated in diabetes treatment trials in the 12 months prior to collection
of baseline data
5) Can families that can't read English
Most of the intervention uses the spoken word or pictures although there
are a few worksheets. One member of the family (young person or carer)
will need to read English. Other family members do not need to be able
to read English but they must have sufficient command of English to be
able to participate in the education sessions.
6) Can we select the families which will
No. it is important that we offer every eligible patient and their families
the chance to take part.
7) We do not perform venepunctures at the yearly reviews, will a fingerpick sample suffice?
No. We need you to collect a venepuncture sample from the young people participating, at baseline, 12 months and 24 months. This ensures that HbA1c levels are accurately measured and that the results we collect from all of our 26 participating clinics are comparable. Samples will be sent to University College Hospital London for analysis. You will be given guidelines which outline the procedure for transportation.
Where possible, we would like the venepuncture to coincide with participants' annual review appointments, so that it is not necessary to perform additional venepunctures. Where it is not possible to coincide with the young person's annual review, then an additional venepuncture should be carried out. Permission will be sought from the young person at the consent stage for blood to be taken for analysis.
8) We don't have a phlebotomist on site to take blood samples. What should we do?
An appropriately trained member of staff within the Trust should collect the sample and offer a local anaesthetic.
The CASCADE intervention
9) Who can attend training sessions?
Any member of staff working in your paediatric and/or adolescent outpatient diabetes clinic is welcome to attend the training sessions including: consultant paediatricians, clinical/diabetes nurse specialists, dieticians and psychologists. One of those attending the training must be a clinical/diabetes nurse specialist. There is no limit to the number of people that can attend from any one clinic.
Staff must attend both training days
10) Will the training sessions be held in London?
Generally the training sessions will be held in London. However, if this is difficult for your team and you are geographically close to another centre involved in the study, then we may be able to provide more local training. The training is designed to be delivered to groups rather than individual health care professionals. The intention is that teams will benefit from sharing ideas about approaches to delivering the sessions. Deborah Christie (Clinical Psychologist and Chief Investigator) and Rebecca Thompson (Clinical Nurse Specialist) will run the training workshops.
11) Who can deliver the education programme to young people and families?
The sessions/modules should be led by a clinical/diabetes nurse specialist with good knowledge of diabetes. Any other member of staff working in your paediatric and/or adolescent outpatient diabetes clinic with good knowledge of diabetes can co-facilitate the sessions. Research nurses (not part of usual clinical team) should not facilitate sessions as they are not part of the usual clinical team. All those delivering sessions must have attended the two training days. We recommend that there are two facilitators per group and that the same facilitators run each block of four sessions.
12) What resources will we need to run sessions?
No special equipment is needed, just a flip chart/ whiteboard, paper and pens.
We will provide you with the CASCADE training manual and other materials needed to run the sessions.
You will need to provide a room with adequate space to accommodate the group.
13) How many sessions will we need to run, and how long do we have to run them?
The intervention consists of a block of four group sessions, delivered monthly over a four month period. Each session will be 2-3 hours in length.
The intervention should be delivered to all the recruited families from your clinic. All patient should have participated in the four groups sessions before their 12 month (post baseline) follow-up is due. Each group will consist of approximately three/four families.
We understand that you may need to be flexible in how you organise the sessions. What is important is that every family attends one session per month.
14) Can a young person attend sessions on their own if they want to?
Young people who are eligible to attend can attend on their own if they wish as long as parents have given informed consent. However, we want to encourage families to participate together as they play an important role in diabetes management.
15) What should we take into account when deciding which young people should be in which group?
Age and developmental level is the most important factor to consider. Where possible each group should be made up of young people of a similar age. This is more important than matching on other factors such as insulin regimens.
It is important that the baseline blood test and questionnaire have been completed before a young person starts their sessions and that they have completed the 4 modules before the 1 year follow-up blood test and questionnaire are carried out.
16) How can we increase the chances of people attending the education sessions?
To maximise attendance at the group sessions we advise that participants should be reminded by phone or text sometime during the week before each module is due to run.
17) Who can accompany a young person to the group?
Young people can bring one or more family members/partners/friends to the group. Bringing very young siblings should be discouraged if possible.
18) What happens if a young person wants to withdraw from the education sessions?
If a young person decides they want to withdraw from the sessions then the nurse should confirm with them that they are happy to continue being part of the research study (i.e. completing follow up questionnaires and blood tests).Wherever possible, this should be encouraged. If the nurse has not spoken with the young person/parent, then they can pass the contact details to the central research team who will contact them to check that they are happy to continue participating in the study.
19) Can we run the sessions with more or less than 3 or 4 families?
Our preference is for sessions to be delivered to three/four families at a time. However if you have a large enough space or circumstances dictate you may decide to include more families to ensure that young people receive the education sessions before their one year follow-up is due.
If only one or two families turn up for a session, then the group can go ahead. You might have to adapt some of the exercises particularly if there is only one family present. If only one family turns up you can offer them the option to complete the module on their own but then join another group for future modules .
20) What happens if a young person/family misses a session?
The four modules/sessions are designed to be delivered to the same group of three/four families. If a young person misses the first module, they will need to complete the module either on their own or join another different group for the next modules. If modules 2 or 3 are missed a participant can continue with the next module. They should not join another group to take this session at a later date. If possible they can be helped to catch up by being given the handouts from the module they missed or one of the trainers can make a time to talk them through the module they missed. The review session at the beginning of each module is also designed to help families catch up with what they might have missed the previous week
21) What happens to the evaluation forms that the young people complete at the end of each module?
These are kept by the young people, in their folder, as a personal record. The blue print for success completed at the end of module 4 is also for the young people to keep.
22) What should we do if one of trainers leaves our clinic and/or is not longer able to deliver the sessions?
If your clinic was unable to train a third trainer during the initial training then please contact us to discuss how we might be able to offer training to another member of your team.
23) Can we carry on running CASCADE sessions once we have finished running them as part of the trial?
Whilst the study is still continuing and we are collecting data from clinics we would be grateful if intervention sites would continue to keep the intervention manual and its resources confidential and not discuss or share them with anyone else from any other clinics.
If you have found the manual useful then we would be happy for you to continue to use the resources as part of your current clinical service. If you wish to do this then we would be happy to email you the resources as a PDF file so that you can print off resources as you need them.
If you are planning to move to a different trust, we would ask that you do not use the resources until the trial has been completed.
Session content and delivery must not be changed, copied or reproduced except for delivery of the groups in a clinical setting .