1. Why was I contacted?

We are contacting approximately 5000 people from all over Alberta who have type 2 diabetes.

You were recently sent a short survey about your diabetes because your family physician identified you as having type 2 diabetes. Based on the answers you gave us, you may be eligible for this study.

OR

You participated in a previous study (ADAPT or a study in the Calgary hypertension cholesterol and diabetes clinic) and consented at that time to being contacted for other diabetes related studies. We have partnered with these other researchers who shared your contact information with us.

2. What is the purpose of this project? What is the Cohort Study?

For this study, we want to follow people with type 2 diabetes for a period of five years. By following trends in answers to the various questions in the survey, we hope to find information that will help us to understand why some people with diabetes develop health complications and while others do not.

3. How is my family doctor involved in this study?

Your family physician is not part of this study. This study is being conducted by researchers in the School of Public Health at the University of Alberta.

4. Will my family doctor know that I’m part of this study?

No. Your family doctor will not know you are part of the study and will not know any of your answers. Only the researchers will know if you decide to take part in this study.

5. Why should I take part in the project?

By participating in this study, you will be contributing to a research project that aims at exploring different aspects of diabetes care and management, and understanding the development of complications in individuals with diabetes. It will help shape the future care of people with diabetes.

6. Will I get money to participate in this study?

No, we are not providing any funds to participants.

7. Are there any risks to me?

We believe there are no risks associated with participation in this study. Some of the questions you are asked may be sensitive. In this case, you may skip any question you like, or withdraw from the project at any time.

8. What does participation involve?

You’ll simply complete the same survey each year. The survey will be mailed to you every year and you can complete it on your own time. A pre-paid self-addressed envelope will be provided for you to return each survey.

9. How much time is involved? When is the study done?

We estimate that it will take about 30-45 minutes to complete each survey, for a total of 2 to 3 hours of your time over a period of five years.

10. Is participation voluntary/Do I have to be in this study?

Participation in this study is completely voluntary. You are free to withdraw from the study at any time. Your health care will not be affected in any way.

11. How will my privacy be protected?

All information you provide will be kept confidential. You will be given a study code in replacement of your name to de-identify you. Any answers you provide or data collected about you will be combined with that from all the other project participants. We will not reveal anything that would identify you.

Data collected will be kept under lock and key at the University of Alberta offices. Data entered into an electronic database for analysis will be password-protected and access to the files will be limited to the investigators.

By signing the consent form, you give permission to the study staff to access any personally identifiable health information, which is under the custody of other health care professionals as deemed necessary for the conduct of research. This information will also be de-identified and be protected as outlined in paragraph 2.

In accordance with University of Alberta policy, all data collected will be kept for a minimum of 5 years, and then will be destroyed.

12. How long will I be in this study?

This study will last five years.

13. What if I have more questions or concerns?

If you have any questions about the study, you may contact the investigators or project manager listed below.

If you have any concerns or questions about your rights as a study participant, you may contact the University of Alberta Health Research Ethics Boards at (780) 492-0302. This office has no affiliation with the investigators or your Primary Care Network.


Investigators:

Principle Investigator: Dr. Jeff Johnson
(780) 492-7317
Co-Investigator: Dr. Me2 (Sumit) Majumdar
(780) 407-1399
Project Manager: Dr Nonsi Mathe
(780) 492-9257