Research: What is Involved?

Informed Consent Forms
Before joining a research study, all participants must first read and understand the Informed Consent Form. All questions are addressed by Dr.Lyttle.This document clearly explains the project, your role in the research study, any risks that may exist, the length of the study and so on. The document has been pre-approved by an ethics committee. We encourage all participants to take as much time as they need to review the information given prior to signing. The Doctor will sign this form with you after all questions are reviewed.

First Study Visit
The first study visit is usually the longest because we need to collect baseline medical information. For example, we ask about your medical and surgical history, your smoking history and your overall health. We also need to know about any current or recent medications, and we check your blood pressure, pulse, height and weight before the study doctor performs a brief physical examination. Blood work, lung function testing, a cardiogram or other medical diagnostic tests may also be performed at this time. Be prepared for 1-2 hours of time.

Follow Up Visits
Once this initial visit is over, you return regularly for brief follow up study visits. At each appointment we ask how you have been since your last visit, whether there have been any changes to your medications and whether you have seen any other doctors or required a visit to hospital. We check your study diary (a record of your medications and symptoms), and collect and dispense medication. Other procedures may also be performed, depending on the particular requirements of the research program. Staff always advises you as to what to expect during your next scheduled visit. Be prepared for 1/2 hour time.

What is actually done by you in-between office visits is determined by the study itself. Usually this means taking a medication and completing a diary card. The medication maybe active or placebo (not active). You or the Research team do not know which. The diary card is for symptoms of asthma, use of rescue medication and sometimes doing peak flow measurements. These recordings are done twice daily.

Final Study Visit
The final study visit may be longer again, if the research program asks for additional information. All study-related items such as medications and diaries are collected and, if required, the study physician may perform another brief physical examination.

Support and Feedback
Throughout these visits, we actively encourage participants to ask questions or voice concerns. We also provide participants with a 24-hour on-call (beeper) number.