eCOA Design Considerations: Reminders and Alarms

Dr. Jill Platko discusses why reminders and alarms are important for the simplest and most complex clinical trials, and how they can be used for optimal subject compliance.

Full Transcript

So one of the things we think about when we’re thinking about designing and design considerations is reminders. And we have reminder alarms associated with diaries. And so even if it’s a reasonably simple solution, so once daily diary, there’s actually some complexity around it, some things that we need to think about.

And the two basic things are, when is this diary gonna be available, and when are we going to remind subjects to do it. And so windows of availability and reminder alarms are things that we think about a fair bit. Windows of availability, when does the diary become available and how long does it stay available.

It’s a balancing between reminding the subjects and annoying the subjects, okay. Ah, and so we can build in some flexibility.

The very basic of this alarm is going to go off at 7:00 for every single subject in the study, period.

It’s not a lot of flexibility. Others allow the alarm to be set by the subject. So the subject says, okay, I want this to go off and 6:00 at night, because that’s probably when I will be answering the diary so I want to be reminded of the time. Another subject will look at that and say, yeah I want to be reminded at 10:00 at night, because I don’t really want to hear this thing going off. So if I’ve been a good subject and completed my diary, I never have to listen to that alarm go off. So I’ll put it a little later, and if I’ve forgotten I’ll be reminded. But I can have some control over this and answer the diary before then. So that flexibility is something that we would probably recommend.

What people sometimes forget is that diaries are habit forming. If you do something on a regular basis, you form a habit. If you don’t do it on a regular basis you don’t form a habit, so if you have a window of availability where you want them to answer something in the evening and you leave it open for 24 hours a day, you’re not training them to answer it in the evening, you’re training them to answer it at any point in time, because you haven’t formed a habit.

And so what we recommend is trying to find that balance between the diary being available enough that you’re not really preventing subjects from entering it, at the same time guiding them to something that is really gonna help them form a habit. So an evening diary should be available probably from somewhere around 5 till sometimes midnight, somewhere in that range, ah, so that they are answering it in the evening as they are supposed to on a daily basis.

And the other thing that’s also often considered to be simple, is reminder alarms. And I can’t stress how important these things are,

But from the sponsor’s point of view, they don’t always think about these things.

So the first alarm goes off and if they respond to it, that’s it, they’re done. If they don’t respond to it, then our standard is 30 minutes later, the alarm goes off again. And if they respond to it, that’s the end of it. And if they don’t it’ll go off one more time.

So those are—those are two things to consider, are ah, windows of availability and reminder alarms, even for the simplest solution. 

About the Author

Jill Platko

Dr. Jill V. Platko is a Senior Scientific Advisor at CRF Health. She has over 16 years of experience in biology-based scientific research and has led projects for renowned institutions such as: Cornell University, Genome Therapeutics Corporation, Whitehead Institute Center for Genome Research, & Massachusetts General Hospital. Dr. Platko completed her PhD in Genetics and Development at Cornell University, and she received a BS in Biology from the State University of New York at Albany.

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