CIT-06 Eligibility Questionnaire

Transcription

1 Today s Date: Last Name: First Name: Middle Name: Date of Birth: Height: Weight (lbs): PERSONAL CONTACT INFORMATION Street Address: City: State: Zip code: Home Phone: Cell Phone: Work Phone: Address: EMERGENCY CONTACT INFORMATION Name: Relationship: Home Phone: Cell Phone: Work Phone: ENDOCRINOLOGIST CONTACT INFORMATION Name: Street Address: City: State: Zip code: Phone: Fax: *In the past year, how many times have you been to your Endocrinologist? Page 1 of 11 vs. July 28, 2010

2 The islet transplant team may be required to provide the following information to the National Institutes of Health (NIH) and/or the United Network for Organ Sharing (UNOS). This information does not determine your eligibility for this clinical trial. Gender: Male Female Ethnicity: Hispanic/Latino Origin Non-Hispanic/Latino Origin Unknown *Do you consider yourself Hispanic or Latino? Hispanic or Latino: A person of Mexican, Puerto Rican, Cuban, South or Central American, or other Spanish culture or origin, regardless of race. The term, Spanish origin, can be used in addition to Hispanic or Latino. Race: (Please Select All That Apply) American Indian or Alaskan Native *A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliation or community attachment. Asian *A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.) Black or African-American *A person having origins in any of the black racial groups of Africa. Terms such as Haitian can be used in addition to Black or African American. Native Hawaiian or other Pacific Islander *A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. White *A person having origins in any of the original peoples of Europe, the Middle East, or North Africa. Unknown Predominant Race: (Please Select One) American Indian or Alaskan Native Asian Black or African-American Native Hawaiian or other Pacific Islander White Unknown Page 2 of 11 vs. July 28, 2010

3 Marital Status: Single Married Divorced Domestic Partner Widowed Northwestern University-Feinberg School of Medicine-Department of Surgery Education Level: (Please Select Highest Level Completed) None Grade School (0-8) High School (9-12) Attended College/Technical School Associate/Bachelor Degree Post-College Graduate Degree Degree (if applicable): Employment Status: *Do you have health insurance? Yes Public Aid Yes Private Insurance No Page 3 of 11 vs. July 28, 2010

4 GENERAL HEALTH QUESTIONNAIRE: 1. Is there anything that would prevent you from providing informed consent and being able to comply with the study visits? Yes No 2. What is your usual blood pressure? 3. If you are a participant in this trial, both males and females must take precautions to prevent pregnancy. Will this be a concern? Yes No 4. Females: How many pregnancies have you had? a. Date of most recent birth: 5. Do you have any active infections (i.e. Hepatitis B, Hepatitis C, HIV or TB)? Yes No 6. Have you ever been TB positive? Yes No a. If so, when? 7. Have you ever had an aspergillus (molds), histoplasmosis, or coccidoidomycosis infection? Yes No 8. Have you ever been diagnosed with cancer? Yes No a. If so, which type? 9. Males: Has your prostate specific antigen (PSA) been greater than 4? Yes No 10. Have you ever abused alcohol or other illicit substances? Yes No a. If so, when? 11. Have you been diagnosed with Factor V Leiden blood disorder? Yes No 12. Do you regularly take blood thinners (except Aspirin)? Yes No a. If so, what do you take? 13. Have you had a heart attack within the past 6 months? Yes No Page 4 of 11 vs. July 28, 2010

5 14. Are your liver function tests elevated (SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin)? Yes No 15. Have you been diagnosed with: a. Acute or chronic pancreatitis? Yes No b. Stomach ulcers? Yes No c. Gallstones? Yes No d. Portal hypertension? Yes No 16. Have you been treated with any anti-diabetic medication other than insulin within the past month? Yes No 17. Have you been given a live attenuated vaccine within the past 2 months? Yes No 18. Have you used any investigational agents within the past month? Yes No 19. Do you have an allergy to: a. Iodine? Yes No b. Shellfish? Yes No c. Sulfa? Yes No 20. Have you ever been given a blood transfusion? Yes No a. If so, what were the specific dates? 21. Please list your current medications with amounts and the start dates in the following table: MEDICATION STRENGTH DOSE FREQUENCY ROUTE START DATE Page 5 of 11 vs. July 28, 2010

6 22. Please list any significant medical history including dates of diagnosis: 23. Please list any surgical history, including dates: Page 6 of 11 vs. July 28, 2010

7 TRANSPLANT QUESTIONNAIRE: 1. What was the date of your kidney transplant? 2. Have you had any other transplants aside from a kidney transplant? Yes No a. If so, which organ? b. If so, what was the date of transplant? c. If you had a kidney and pancreas transplant and lost the pancreas graft, how soon after the transplant did this occur? d. If your pancreas graft failed, was it removed at that time? Yes No 3. What was your most recent serum creatinine? 4. Has your creatinine level been stable for the last 3 months? Yes No 5. What percentage is your Panel Reactive Antibody (PRA)? 6. Do you routinely see an Opthalmologist/Retinologist for your eye care? Yes No a. If so, do you have retinopathy? Yes No b. If you have retinopathy, is it treated and stable? Yes No 7. Have you been told that you have protein in your urine since your kidney transplant? Yes a. If so, how much? No 8. Did diabetes cause your kidney disease? Yes No a. If not, what did cause your kidney disease? 9. Have you ever had an islet transplant? Yes No Page 7 of 11 vs. July 28, 2010

8 DIABETES QUESTIONNAIRE: 1. What year were you diagnosed with diabetes? 2. What year did you begin insulin therapy? 3. How long have you been insulin dependent? 4. Do you inject or use a pump to manage your diabetes? Inject Pump 5. If you inject insulin, how many injections do you take during a typical day? 6. What is your average range of insulin use during a typical day? 7. How many times during the day do you check your blood sugar? 8. What was your most recent HbA1c? 9. In the past year, have you had an episode of severe hypoglycemia, defined as an event with one of the following symptoms: memory loss; confusion; uncontrollable/irrational behavior; unusual difficulty in awakening; suspected seizure; seizure; loss of consciousness; or visual symptoms, in which you were unable to treat yourself when your blood sugar was less than 54 mg/dl, OR prompt recovery after oral carbohydrate, IV glucose, or glucagon? Yes No 10. Have you experienced DKA within the last 12 months? Yes No 11. Have you been hospitalized for DKA within the last 12 months? Yes No a. If so, how many times? Page 8 of 11 vs. July 28, 2010

9 CLARKE SURVEY: 1. Check the category that best describes you: (check only one) I always have symptoms when my blood sugar is low I sometimes have symptoms when my blood sugar is low I no longer have symptoms when my blood sugar is low 2. Have you lost some of the symptoms that used to occur when your blood sugar was low? Yes No 3. In the past twelve months, how often have you had hypoglycemia episodes where you felt confused, disoriented, or lethargic and were unable to treat yourself? Never Once or Twice Every other month Once a month More than once a month 4. In the past twelve months, how often have you had hypoglycemia episodes where you were unconscious or had a seizure and needed glucagon or intravenous glucose? Never 7 times 1 time 8 times 2 times 9 times 3 times 10 times 4 times 11 times 5 times 12 times 6 times 5. How often in the last month have you had readings less than 70 mg/dl (3.9 mmol/l) with symptoms? Never 1-3 times 1 time/week 2-3 times/week 4-5 times/week Almost Daily Page 9 of 11 vs. July 28, 2010

10 6. How often in the last month have you had readings less than 70 mg/dl (3.9 mmol/l) without symptoms? Never 1-3 times 1 time/week 2-3 times/week 4-5 times/week Almost Daily 7. How low does your blood sugar go before you feel symptoms? mg/dl ( mmol/l) mg/dl ( mmol/l) mg/dl ( mmol/l) < 40 mg/dl 8. To what extent can you tell by your symptoms that your blood sugar is low? Never Rarely Sometimes Often Always * Please briefly describe how the complications of diabetes affect your life and/or the lives of others around you: Page 10 of 11 vs. July 28, 2010

11 Please return your completed questionnaire via (preferred), fax, or mail to the attention of: Elyse Stuart, RN, BS, CCRC & Angela Hecyk, BS Phone: (312) Phone: (312) Northwestern University Feinberg School of Medicine Comprehensive Transplant Center Clinical Research Group 676 North St. Clair Street Suite 1900 Chicago, IL Fax: (866) Please do not hesitate to contact me if you have any questions. Page 11 of 11 vs. July 28, 2010