The eMonitoring Project
Information Sheet
1. Purpose of study
2. What do I have to do?
3. What good does it do?
4. Who can take part in the project?
5. What kind of electronic monitoring are you testing?
6. What happens to my data?
7. What do I get out of it?
8. What if I change my mind?
9. How do I enrol for the study?
Invitation: You are invited to take part in the following study
Title of project:
Electronic Monitoring of Symptom Variability in Bipolar disorder
The purpose of this study is to examine how your symptoms change from day to day using a range of electronic monitoring methodologies (mood diaries and activity monitors). Our main aim is to find out how easy and practical it will be for individuals with bipolar disorders (also known as manic depressive illness) to use such electronic systems to monitor themselves. We also want to find out how useful this type of intensive daily monitoring is for predicting the course of bipolar disorder, and any changes that occur with different treatments.
The study has been granted ethics approval by the Institute of Psychiatry ethics committee (ref: 284/03), and was originally funded by the Medical Research Council. It is currently partially funded by a small grant from the British Council (Medical Informatics scheme) and the department of Psychological Medicine, and continues through the PhD project of Yanni Malliaris at the Institute of Psychiatry. It is jointly hosted at the departments of Psychology and Psychiatry and Health Services Research.
If you choose to participate you will have to go through an initial assessment that will involve completing some brief screening questionnaires. These will help us to determine the version of the eMonitoring that will be most suitable to your needs and our current requirements. Then you may be invited to have an interview (lasting about 1-1.5 hours) that will help us to get to know your history a bit better. Participants in the remote arm will complete the baseline interview using web-based self-report assessments. Then, if you decide you wish to take part in the monitoring programme you will be taught how to use the electronic equipment (this brief training usually takes about 30 minutes, but may be faster or slower depending on whether you have used electronic diaries before). Ideally, we will ask you to make a commitment to do the self-monitoring on a daily basis for about 3 months (you may continue for a maximum of 6 months if you wish). Using the electronic monitoring system to record your symptoms takes no longer than 3-5 minutes per day, so the actual time commitment is small.
During the 3 months that you undertake daily self-monitoring you will be in regular telephone contact with one of our research assistants (RA), and you will have weekly telephone conversations about your progress (lasting about 30 minutes). Once you have finished the daily self-monitoring period you will be invited to attend a review meeting. This will last about 45 minutes and there would be four meetings over a year (one every three months) to check on the progress of your treatment and to monitor if you have experienced any major relapses. To make things easier and allow the participation of people who live outside London we will try to do the majority of our assessments remotely (using telephone, internet, and postal services). Participants in the remote arm will go through a similar process but will receive training and input on how to do the weekly and monthly self-reviews on their own.
This project will not change any of your current treatment, but with your help we will be able to understand the pros and cons of using electronic monitoring in clinics and in research, instead of relying on your memory of how you have been between appointments. Your feedback will also help us to understand how your symptoms may vary from day to day and what effect they have on your quality of life.
4. Who can take part in the project?
We are looking for people with a history of bipolar disorders who would be prepared to undertake regular self-monitoring using an electronic diary. We would like to recruit individuals who are not currently experiencing an acute episode of depression or mania, although you may have some symptoms of bipolar disorder. It is also important that you are in contact with a community mental health team or a psychiatrist who is helping you to cope with your problems and to manage your current treatment.
If you live outside the areas of the South London and Maudsley (SLAM) Trust, then we may ask to have confirmation of your diagnosis and a referral from your treating doctor. It would also be good if we had some contact with your partner, or a close friend who has regular contract with you. This is only to ensure that if something goes wrong there will be someone to contact. Our initial assessments will help you and us decide how feasible it would be for you to participate in this study, and whether it is a good time to try this. If you are suitable and wish to participate in the study, your medical records will be looked at by our research team in order to assist our assessments.
If you are not suitable to participate in the study either because you live too far away or for some reason you do not meet our research criteria but nevertheless you are still willing to try this electronic symptom monitoring programme you may still be able to participate through our Remote eMonitoring arm of the project (see www.bipolarlab.com/emonitoring/remote for further details)
5. What kind of electronic monitoring are you testing?
We will use two electronic mood diaries. The first one is called ChronoRecord and runs on a personal computer (PC). The second system is called iMonitor and runs on a little pocket computer (Palm Personal Digital Assistant, PDA). Both systems simply require that you answer questions on a daily basis about your sleep, daily functioning, mood, symptoms, life events, and medication. Obviously, you will need to have access to a PC to use ChronoRecord, but for iMonitor we will provide you with a little pocket computer called PDA (such as a palm pilot) to use during the study. We will also give you an activity monitor (a pedometer that is a device that you wear on yourself), which simply measures your overall activity level, and is a more objective measure of your activity levels.
Due to our limited resources priority for the equipment will be given to patients who receive their services from the South London and Maudsley Trust. For everyone else who is suitable and willing to participate we can provide the software at no cost and advise how to buy their own equipment. Training will be provided at no cost to all suitable participants.
The decision about whether you use our PDA diary (iMonitor) or our computer diary (ChronoRecord) (if you have access to a PC) will be made randomly. This is like the throw of a dice, and neither you nor the researcher will know which you will be asked to use until the researcher contacts a third person by telephone who will identify which system is listed next on the ‘random allocation’ table. However, as we are keen to know what people think of these monitoring systems and to get your views, we will also give people the opportunity to try the other method of self-monitoring if they don’t like or can’t use the one they are offered first.
All the data you record and provide is confidential. We abide to the rules of the Data Protection Act which means we have to store the data in a way that you cannot be identified personally from the information in our research files and none of the data will ever be given to anyone other than the research team. For the electronic diary you will be provided with a special password that will guarantee that only you have access to your self-monitoring records. This means that, for example, if the PDA is lost no one else will know who you are, and they will not be able to open the file with your diary in it.
You will get the opportunity to participate in a detailed review of the history of your problems and how you have coped with them, and then learn about methods of self-monitoring. These may be useful in your consultations with your key worker or psychiatrist and in developing your own self-management skills.
We will provide all the training needed to use these self-monitoring systems, and we will support you in learning to use these electronic systems throughout the study.
You will get the chance to have 12 weekly telephone discussions (or self-reviews in the remote arm) where you will be able to discuss your progress and to review how things are going for you.
At the end of each month of self-monitoring we will send you the graphs showing you how you have rated the changes in your symptoms and daily functioning for you to keep.
We will cover all the costs of the equipment and software (for suitable participants only). This means that you get the opportunity to try these systems out and discuss their pros and cons with experts without having to buy one yourself.
That’s OK! You may withdraw at any time and no questions will be asked. Your participation in this study is entirely voluntary, agreeing to try to do self-monitoring or agreeing and then withdrawing from the study will not affect your treatment from your usual clinical team in any way whatsoever. We totally understand that your circumstances may change or you may find it too much trouble to do this monitoring on a daily basis – we are trying to learn how acceptable this programme is to all individuals with bipolar disorders, so even if you start the programme but then find you cannot participate anymore it will help us understand what percentage of people can continue to use these programmes and what proportion have to stop using such systems.
9. How do I enrol for the study?
If you have any further questions contact Yanni Malliaris at any time by phone +44-207-848-0320, Skype: emonitoring (account name) or via email. Yanni will help you to get started.
Look at the skype icon to see if he is online to chat with you:
