Vicky - Interview 36

Age at interview: 39

Brief Outline: Vicky gave consent for her daughter to take part in a clinical trial when attending a routine clinic visit. The trial was a randomised trial on the way information is given to young people with diabetes.

Background: Vicky is aged 39 years, is White British, married with three children all under 12 and has full-time employment. Her 9 year old daughter was diagnosed with diabetes at the age of 2.

More about me...

 Vicki’s nine year old daughter was diagnosed with diabetes at the age of two. Vicky gave consent for her daughter to take part in a clinical trial to determine the best way to give information to young people with diabetes. Vicki and her daughter were happy to take part. Theywere approached by a researcher at a clinic appointment and asked whether they would take part in a trial. They were told at that time that it was related to the way information is given to children with diabetes and involved filling in a questionnaire when attending normal clinic appointments “And we filled one of those in each time we went. And I think in total there were maybe three or four. And it was all related to sort of how my daughter felt about particular things to do with her treatment, to do with the way some of the medicines made her feel, how she got on in sort of day-to-day, day-to-day life.” 

 

The trial was a randomised trial. Participants were randomly allocated to the standard treatment or the treatment group. The standard treatment received care as normal. The treatment group received a new style information pack. Vicki explains' “it wasn’t to do with changing her treatment, her medicines or anything like that; it was just to do with information.” They were allocated to the standard treatment group so nothing changed for them apart from filling in the questionnaire... “I mean that was a bit disappointing because you always think if there’s something new coming along then it might be useful to see it.”

 

Vicki would certainly consider taking part in something similar for her daughter again; she does feel that if the trial was about changing her daughter’s treatment or affected her health she would have to give that more thought.

 

Vicky and her daughter were randomised to receive the existing information pack. She understood the trial was being done to understand if a new method of delivering information should be rolled out to all children and young people.

 And I mean when we first agreed to do the trial, it, I mean I think the fact that it was all to do with information and it wasn’t to do with changing her treatment, her medicines or anything like that, it was just to do with information. And I guess as a result of that maybe we didn’t think about it as much as we might have done if it had been, you know, there’d have been more impact if it had been a change in treatment or sort of a new treatment that was coming out. But even so, I mean when they said that it would be a random selection as to whether we would get the new pack of information or the old pack of information, and we were actually selected for the old, for the old pack of information. So in actual fact nothing changed for us in the way that anything was happening with my daughter’s treatment or the information even that was given. I mean that was a bit disappointing because you always think if there’s something new coming along then it might be useful to, to, to see it. Because I guess if as a result of the trial it’s decided that’s not the best approach, then we’ll never see that. But then it’s not the best approach, is it? They’ve made that decision based on the research. So I think that, that’s fine. And, you know, initially when they said that we would get the standard information, then, you know, it was a bit, “Oh, what a shame.” But it’s, I think it’s, it, it’s worked out fine. And we’ve not seen any differences. So, you know, there’s, there’s not been any impact from that point of view. And it has just been answering the, the questions on general every day, day-to-day stuff really.

Supporting children and ensuring they have all the information they need will be important when they cannot legally consent themselves to take part in a trial.

 No, well, I don’t know. No, it’s not really come up. But I can see that it perhaps will come up. I mean just through the nature of people wanting different things and thinking, you feeling what’s best for your children and them thinking what’s best for them. So I’m sure that, yes, has a potential to be a problem. And I don’t know what you do about it. I suppose ultimately it is their choice, but you’ve got to help them come to that decision, you know, with having all the information that you can give them.

If you think there is a new and better treatment then you want it, but until they have done a trial we don't know which one is best.

 And I mean when we first agreed to do the trial, it, I mean I think the fact that it was all to do with information and it wasn’t to do with changing her treatment, her medicines or anything like that, it was just to do with information. And I guess as a result of that maybe we didn’t think about it as much as we might have done if it had been, you know, there’d have been more impact if it had been a change in treatment or sort of a new treatment that was coming out. But even so, I mean when they said that it would be a random selection as to whether we would get the new pack of information or the old pack of information, and we were actually selected for the old, for, for the old pack of information. So in actual fact nothing changed for us in the way that anything was happening with my daughter’s treatment or the information even that was given. I mean that was a bit disappointing because you always think if there’s something new coming along then it might be useful to see it. Because I guess if as a result of the trial it’s decided that’s not the best approach, then we’ll never see that. But then it’s not the best approach, is it? They’ve made that decision based on the research. So I think that’s fine. And, you know, initially when they said that we would get the standard information, then, you know, it was a bit, “Oh, what a shame.” But it’s, I think it’s worked out fine. And we’ve not seen any differences. So, you know, there’s not been any impact from that point of view. And it has just been answering the, the questions on general everyday, day-to-day stuff really.

 

Was, did your daughter understand that, that bit, you know, that she wasn’t getting something?

 

Yes, yes, and I think, well, I think she was, yes, she was disappointed, yes. Because, well, I don’t know what I imagine the new information to be like or the new way of delivering it. I don’t know. But, you know, you expect it to be all singing and dancing.

 

What is the standard information, how do they…?

 

Well, I don’t know, because that’s what, we’ve already had it. I mean we go to an appointment and we basically just have a conversation with the consultant and the diabetic nurse about how things have been going, and they pass on any information that is new that they’ve discovered. For example, there was a new book which is all to do with carb counting, which the diabetic nurse told us about. And so it’s just like that really, just sort of in a conversation style.

 

Vicky was a little disappointed her daughter was allocated to the standard treatment group.

 I don’t know whether they explained it. But I think, well, my understanding is that obviously they’ve got to pick some people who will get the new pack of information, or the information in a new way, and there have got to be some who, who continue with it the existing way, obviously to view what the results of the outcome of the study are. And I think the researcher went away and did something on a computer and it came up with a, with a magic number and, “Oh, right, you know, you’re going with the…” So I’m presuming that it was just a randomiser in that it just randomly chose whether we were going to be yes or no.

 

You were slightly disappointed that you didn’t get the –

 

Yes.

 

the new pack?

 

Vicky would like to know the outcomes of the trial and whether her daughter's treatment should change as a result.

 Well, I mean I suppose, I feel that I would quite like to know the outcome of the trial and to see, you know, to see what then they will change as a result, if anything. Because I guess things may stay exactly the same. But it will be useful to know that, you know they had assessed everything and then decided that they would stick delivering information in the same way. But apart from that, no real feelings as it ended, you know.

 

Yes, no, it would be useful, I think. But there was nothing mentioned. And I did, when I came home in fact the other week, last week I did think, “Really I should have asked what happens now.” Because it was all really, “Right, that’s complete and that’s the end” sort of thing, “Thank you very much.” And I should have thought at the time really.

 

The decision to take part is easier when the risk is very low. If the risk had been greater, Vicky would have thought more about it.

 Well I didn’t see any negatives in doing it. In, sort of in not doing it there, there wouldn’t have been any, any, it wouldn’t have helped anybody. We wouldn’t have been any better off apart from, you know, not having to sit and do the questionnaires, which really wasn’t a chore at all. There was no reason not to. You know, it wasn’t a major dilemma. You know, if, if it was all about treatment and things like that. I mean I know information is treatment as well. But, so there were, there wasn’t really much of a, you know, the motivation was, “Well, we might as well, seeing as we’re here. And, you know, it, it might help towards changing things for the better, if that’s the way it needs to be.”

 

I suppose if, perhaps if there’d been some change to treatment or some other risk there –?

 

Then it could well have been different, I think. Yes, because obviously, yes, if there had been change to treatment which potentially would have an effect on her health, then I think that would have, you know, we would have had to have considered that a lot more, yes.

 

Vicky didn't understand how the questions in the monitoring questionnaire related to the trial intervention.

I mean it was funny because when we were filling the questionnaires in, quite often I did think back and think, “Well, I don’t understand what these questions have got to do with, you know, the way information is given to children with diabetes.” But, and I still don’t really understand that. I mean they’re all very useful questions to ask and it may be useful to understand over a period of six, nine months, however long it was, to understand the answers and, and how they changed in that period and how they differ from, you know, overall. But I couldn’t work out how it related to, you know, the topic, which was about the way information was given. But maybe that would have been clear if we’d have been on the other side of it.

 

What sort of questions were they?

 

Well, they were things like, “Do you get upset because you have to sort of alter your schedule at school? Or, “When you’re with your friends do you get upset because you’re different because you’ve got diabetes?” Or, and so it was, it was, there were questions around feelings and embarrassment of injecting in restaurants. And so my daughter had questions like that in her set, and we would have to answer the same sort of questions but, “Did we feel that she was embarrassed?” And also things like, “Does she find it difficult giving herself the medication?” or, “Does she complain about it being painful where she injects?” and things like that. So it was, and also I mean things like, “Does she get grumpy often? Tired often?” So all sort of symptoms related to the condition.

 

That’s interesting.

 

Yes, but, I mean it was interesting and I think that’s quite interesting, and I think it also would be interesting looking at the difference between how she views her condition and how we view her condition. Because I think there would be some useful bits and pieces to be, because I know sometimes I filled in that she often gets grumpy, because she, I think she does. But her view was that she didn’t often get grumpy [laugh]. But I don’t know. But, yes, it was difficult to sort of relate it back to what I thought the main trial was about.

 

Like many parents, Vicky felt that it was better to discover there was a money voucher at the end of the trial rather than being informed about it at the start.

 We’ve received some vouchers. My daughter’s received some vouchers. And I, I don’t remember them saying at the start that we would get them. But they’ve given her a voucher each time we’ve, we’ve filled the [questionnaire]

 

Was that each time you went to the clinic [Yes.] and complete, you completed a questionnaire?

 

Completed a questionnaire, and they’ve given her a voucher, yes. So that was quite good. And I don’t remember them saying at the beginning. They may have done. But…

 

Do you think it’s important that the young people receive something?

 

I don’t think it’s important, no. Because I think in a way they should do it for the potential medical benefits that it might give, even not to them, to others with similar conditions or who’ve been through similar situations. But I think it’s nice. I mean it’s only a token. You know, you’re not getting paid hundreds of pounds or anything. But no, I think it, I think it’s nice that they appreciate that you’ve done, you know, sat there and done these for them. But I don’t, I don’t think it’s, it should necessarily be that you get paid or compensated for it really.

 

I think most parents have said that, that they wouldn’t want it to be in the information. It’s nice to have it afterwards. [Yes.] And a voucher is better than perhaps money?

 

Yes, yes, I think so, yes.

 

I’m just thinking in terms of possibly encouraging young people to take part in these things, whether it should be upfront or whether it should, better at the end?

 

Yes, I don’t know.

 

How did your daughter feel when she received?

 

Well, she was nicely surprised, yes. Yes, it was nice. She was pleased.

 

Vicky will ask about the results of the trial at her next appointment.

 Well, I guess the only thing would be maybe to explain a bit more how the questionnaires related to what they were trying to get out of the trial really. Because as I said earlier, it, sometimes I thought, “Well, I really don’t know why they’re asking this” related to the topic of the, the trial. But, so I think that would have been perhaps useful. And also the follow-up. So, you know, informing us of the outcome. Obviously we’ve only just finished, so there’s time for that to happen. But there was no mention that that would happen in the near future. And I should have asked. But, but I think that would certainly be useful for any trial.

 

So when is the follow-up?

 

Well, we go back in another three months. But I’m not sure whether the, the research lady will be there, because presumably she’ll have finished collecting all her data.

 

So what happens at the follow-up?

 

Well, at the follow-up we just have our normal appointment with the consultant. And I guess at that point if they’ve had the results of the trial then maybe things will start changing for us, you know the sort of information and things like that.

 

Vicky would have liked more explanation about the purpose of trial and to be informed of the outcomes of the trial.

 Well, I guess the only thing would be maybe to explain a bit more how the questionnaires related to what they were trying to get out of the trial really. Because as I, as I said earlier, it, sometimes I thought, “Well, I really don’t know why they’re asking this” related to the topic of the, the trial. But, so I think that would have been perhaps useful. And also the follow-up. So, you know, informing us of the outcome. Obviously we’ve only just finished, so there’s time for that to happen. But there was no mention that that would happen in the near future. And I should have asked. But I think that would certainly be useful for any trial.

 

So when is the follow-up?

 

Well, we go back in another three months. But I’m not sure whether the, the research lady will be there, because presumably she’ll have finished collecting all her data.

 

So what happens at the follow-up?

 

Well, at the follow-up we just have our normal appointment with the consultant. And I guess at that point if, if they’ve had the results of the trial then maybe things will start changing for us, you know, the sort of information and things like that.

 

Vicky would consider other trials if it would help her daughter and other children with diabetes and other long-term conditions.

There would, there would be a point. But I think it’s difficult to know what that point would be. Because I mean obviously a change in her treatment which may have direct effect on her health, then I think we’d sort of have to look into it more and understand more about, you know, the development of that particular drug, say, beforehand and how far they’d got and whether it was likely to be successful and, and things like that. I think, yes, anything which would have an impact on her health, then we’d consider. And I mean I don’t know what the point would be where we would say no, because obviously the only way that you get to see whether new things work is by trialling them. But obviously it’s that balance, isn’t it? Between letting somebody else do it.

 

Yes, that is something that we’ve thought of. And I mean you always, when you hear about a new treatment you always think, “Oh, you know, when will that be available? When can we start doing that?” But obviously it takes a long time for that to happen. And so I think, yes, if anything came up like that then we would consider.

 

Yes, yes. So, yes, if you, if you take part in it you may only be helping other people and not yourself. But I suppose people who have a long-term condition perhaps understand that even that is still worthwhile doing, you know, because they understand what it’s like to live with that condition. So, you know, even if they’re helping other people. But again there’s got to be that balance between helping other people and it being detrimental to you. So, yes, I think those are the considerations.