Your First Visit
Your initial visit for Enroll-HD will be a little bit like a regular visit to an HD clinic, but it’s different in some important ways. The main difference is that instead of being a patient you’re now a study volunteer, which means that you are providing information, not getting counseled about your health. It’s a one-way street.
Informed consent, in two parts
The first visit involves a lot of paperwork. First, you’ll talk over the informed consent form with the site coordinator or study nurse, who can answer all of your questions. That’s the informed part, to make sure you know enough about the study to decide whether it is right for you to join. It might take 30 minutes or so to discuss everything on the lengthy form if you’ve never been part of an HD observational study before. The site can send you the form ahead of time so you can read through it and think about questions you might have.
If you decide to join the study, you will sign the informed consent form. That’s the consent part. By signing the document, you will have consented to take part in Enroll-HD.
You’ll also talk about your medical history—if you have symptoms, when you were first affected—and what medications you’re currently taking and formerly took. If you already gave that information as part of REGISTRY, you’ll only need to update this information if anything has changed recently. If you are willing, you will also describe your family history with HD (this is optional).
Your secret code
You’ll provide a few details about yourself, such as your name, birthdate, and, just like with a bank account, some other more secure details that only you and your family will know. These will be used to generate a unique HDID code that will be associated with all your information for the Enroll-HD study. This code is the only way to identify your records. Your name and other identifying information will not leave your clinical site. It will never be typed into the Enroll-HD database for people outside your clinical site to see.
During this first visit you’ll meet with the neurologist, who will work with you to do a functional and motor assessment. You’ll take some tests to measure memory and thinking, which are like brainteasers or puzzles that you do with paper and pencil. You’ll also be asked about your mood—whether you’ve been depressed or are having other psychological or emotional difficulties. You’ll also give a blood sample, which will be sent to a secure biorepository—a specialized lab that stores biological samples at high security. To further protect your privacy, this blood sample is given a special code, which is different from the HDID number that you use for the other parts of the study.
What it means to participate
While you’re doing these evaluations, you’re officially a participant rather than a patient. The people working with you are now in the role of researcher, even if they are normally one of your care providers. That means that during this visit they won’t tell you how well you do on the evaluations, or give you advice regarding your health.
The first visit may take between 1½ and 2½ hours, although each site is slightly different. Follow-up visits may be less than an hour or up to two hours, depending on the site. At some larger sites that also provide regular medical care for HD, it may be possible to schedule your regular clinic visit and your Enroll-HD visit for the same day.
The visit itself is pretty straightforward, says Tony Mims from Australia, who helped launch an HD support group called the Australian HD Youth Alliance. But it can be a long day, and can bring up fears about the future and other difficult feelings. He recommends that before the visit participants make sure that they will have someone to talk to afterward if they need the emotional support. “People need to make sure they have a strong support network, whether it’s a professional or a partner, if they feel a bit sad afterward, or have questions.”