https://watarts.uwaterloo.ca/~diabetes/survey1/where you will be prompted to enter your logon ID and password.
You are being invited to participate in a research study in the Diabetes Clinic at the Toronto General Hospital or McMaster University Medical Centre. This study is part of a doctoral dissertation for Michael Coons, M.A., under the supervision of Dr. Peter Hall at the University of Waterloo, in conjunction with Dr. Gary Rodin at the Toronto General Hospital and Dr. William Harper at McMaster University.
Achieving an ideal blood sugar level can be a challenge for people with diabetes. Nonetheless, doing so is important to minimize the risk of developing long-term medical complications (e.g., blindness, kidney failure) associated with chronically high blood sugars, while also minimizing the risk of having low blood sugars, which can place people in physically dangerous situations (e.g., driving a vehicle). This study is being conducted to better understand how certain emotions (e.g., fear, worry), affect how people with diabetes self-manage their condition. Results from this study can potentially help both healthcare providers and researchers to help people with Type 1 diabetes to reach better blood sugar control.
The purpose of this study is to understand more about people's feelings and opinions about living with diabetes. Specifically, the surveys involved in this study ask questions about your general physical health, about your emotions and feelings toward managing your illness, and about how having Type 1 diabetes has impacted on your life (e.g., physically, emotionally, socially). We are interested in exploring how certain fears and concerns (i.e., fear of low blood sugars, fear of long-term diabetes-related medical complications) influence how people with Type 1 diabetes self-manage their condition, and examining how these concerns may or may not affect their quality of life.
If you volunteer to participate in this study, we will ask you to do the following things:
Visit a secure website using your home computer to complete an online survey that will take approximately 30 minutes. To access the online survey, you can go to the following Internet address https://www.arts.uwaterloo.ca/~diabetes and login using the unique ID and password given to you when you sign up for the study. (Note: The website is programmed to collect responses on the survey alone. That is, the site will not collect any information that could potentially identify you (such as unique machine identifiers).
There are no known or anticipated risks with participation in this study. However, it is possible that some participants might experience temporary feelings of anxiety when reading or responding to some of the questions. However, we expect that these effects would be short-lived.
If you choose to take part in this study, you will be told about any new information that might affect your willingness to continue to participate in this research.
The total number of participants needed in this study is 330. This will include approximately 165 participants from McMaster University Medical Centre, and 165 participants from the Toronto General Hospital. However, upwards of 600 people with Type 1 diabetes will likely be invited to participate in this study.
Although your participation may not have any direct benefits to yourself, your data will help healthcare professionals and researchers to determine how patients with Type 1 diabetes can improve their blood sugar control, which in turn, may reduce the risk of future health problems and improve the quality of life of people with diabetes.
Your data will not be shared with anyone except with your consent or as required by law. All personal information such as your name, address, phone number, OHIP number, family physician's name will be removed from the data and will be replaced with a number. A list linking the number with your name will be kept in a secure place, separate from your file. The data, with identifying information removed will be securely stored in an electronic file on the Hamilton Health Sciences computer server. Once this information is saved electronically, all paper records will be destroyed using a confidential shredding system.
Data collected through the online surveys (initial survey, 1-year and 5-year follow-ups) will be stored on a secure computer server housed at the University of Waterloo. Each participant can complete the surveys using a unique login ID and password (listed above). The online survey is designed to collect your answers to the survey questions only, and will not collect other information that could potentially identify you (such as unique machine identifiers). Any surveys that are completed by paper copy will be entered electronically into a computer database in the Health Behaviours Laboratory, Room 1013, Burt Matthews Hall, University of Waterloo, before being destroyed using a confidential shredding system.
For the purposes of ensuring the proper monitoring of the research study, it is possible that a representative of the University Health Network/Toronto General Hospital Research Ethics Board, Hamilton Health Sciences/McMaster University Research Ethics Board, or University of Waterloo Research Ethics Board, may consult your research data and medical records. However, no records that identify you by name or initials will be allowed to leave the hospital. By signing this consent form, you or your legally acceptable representative authorizes such access.
If the results of the study are published, your name will not be used and no information that discloses your identity will be released or published without your specific consent to the disclosure. However, it is important to note that this signed consent form and the data that follows, may be included in your health record.
Since participation in this study is completely voluntary, even after agreeing to participate, you have the right to withdraw from the study at any time, and will in no way affect the quality of care that you receive at Toronto General Hospital or McMaster University Medical Centre for your diabetes. You may also refuse to answer or skip any questions that you do not want to answer and still remain in the study. To withdraw your participation at anytime, simply inform any member of the research team by using the contact information found at the bottom of this letter.
If you agree to take part, we will reimburse you a total of $20.00 for study related expenses. This included $10.00 for the completion of the initial survey, and $5.00 for each of the surveys at the 1-year and 5-year follow-up assessments. In the event that you cannot complete the requirements of the study, you will receive payment for any section that you complete (e.g., initial survey only). A cheque will be mailed to you after each survey completed to an address that you provide the research team (home, or otherwise).
Your participation in this research project will not involve any additional costs to you or your health care insurer.
If you are injured as a direct result of taking part in this study, all necessary medical treatment will be made available to you at no cost. Financial compensation for such things as lost wages, disability or discomfort due to this type of injury is not routinely available. However, if you sign this consent form it does not mean that you waive any legal rights you may have under the law, nor does it mean that you are releasing the investigator(s), institution(s) and/or sponsor(s) from their legal and professional responsibilities.
This study has been reviewed and received ethics clearance by the Office of Research Ethics at the University of Waterloo, Hamilton Health Sciences/Faculty of Health Sciences McMaster University, and University Health Network, Toronto General Hospital. However, the final decision about whether or not to participate in this study is yours. If you have any questions regarding your rights as a research participant, or have concerns about this study, you may contact Dr. Ronald Heslegrave, at the Office of the Chair of the University Health Network Research Ethics Board at 416-946-4438, Dr. Susan Sykes, Director, Office of Research Ethics, University of Waterloo at 519-888-4567 ext. 36005 or at ssykes@uwaterloo.ca, or Dr. Jack Holland at the Office of the Chair of the Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board at 905-521-2100, ext. 42013.
To ask any questions that could help you in deciding whether or not you wish to participate in this study, to request a paper copy of the survey, or to withdraw your participation from this study, please use the following contact information:
Dr. Peter A. Hall, Ph.D. (Principal Investigator) or Michael Coons, M.A. (Study Coordinator)
Email: diabetes@uwaterloo.ca Tel: (416) 710-7762 (519) 888-4567 ext. 38180
THANK YOU!