ࡱ> []Za Gbjbj[[ 4\9bE\9bE\X?D D 8$,4 r``(w $z!0$Vww333333:,f#v s0  $$"$33 $D > : University of North Carolina at Chapel Hill Assent to Participate in a Research Study Adolescent Participants age 15-17 ________________________________________________________________________ Consent Form Version Date: 2/21/2016 IRB Study # 07-0352 Title of Study: Successful Transition to Adulthood with Therapeutics (STARx) Principal Investigator: Maria Ferris Principal Investigator Department: Unc Kidney Center Principal Investigator Phone number: (919) 966-2561 Principal Investigator Email Address: maria_ferris@med.unc.edu Funding Source and/or Sponsor: Renal Research Institute What are some general things you should know about research studies? You are being asked to take part in a research study. Your parent, or guardian, needs to give permission for you to be in this study. You do not have to be in this study if you dont want to, even if your parent has already given permission. To join the study is voluntary. You may refuse to join, or you may withdraw your consent to be in the study, for any reason, without penalty. Research studies are designed to obtain new knowledge. This new information may help people in the future. You may not receive any direct benefit from being in the research study. There also may be risks to being in research studies. Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study. You will be given a copy of this consent form. You should ask the researchers named above, or staff members who may assist them, any questions you have about this study at any time. What is the purpose of this study? The purpose of this study is to learn more about howpatients who have been diagnosed with a chronic health condition as a child grow into adulthood, from their own point of view and the point of view of their parents and caregivers. You are being asked to be in the study because you have a chronic health condition that was diagnosed in childhood. Information about you and other patients will be combined to help us improve what we teach transition-age patients and their families about chronic health conditions and about growing into healthier adults. Are there any reasons you should not be in this study? You should not be in this study if you do not feel comfortable talking about various aspects of your health (i.e., physical, mental, sexual, etc). How many people will take part in this study? As of this year, there are approximately 850 participants enrolled in this study. This year we anticipate enrolling around 100 new participants. As our study is taking place over many years, enrollment is ongoing indefinitely. How long will your part in this study last? This is an ongoing study that will last until you and/or your parent withdraws consent. We will continue to use your medical informationin this study even if you become deceased, unless you withdraw consent beforehand. The next sectionprovides an estimate ofhow long each tool/questionnaire you may be asked to complete will take you. You can spend as much time or as little time with the researcher(s) as you desire. Your participation is completely voluntary and at your discretion. What will happen if you take part in the study? If you choose to participate in this study, you may be asked toanswer some or all of the following questionnaires during the course of your study enrollment. You will NOT be asked to completeall of them during one visit. Most of the questionnaires are online, so they can be emailed to you for you to do at home if you prefer. REALM (Rapid Estimate of Adult/Adolescent Literacy in Medicine): You may be asked to read a list ofcommon medical words and lay terms for body parts and illnesses aloud. This will help your medical team know how to bettercommunicate with and teachyou about your condition and medications. It will take no more than 2-3 minutes to complete and you will only be asked to do this once. Parent survey on Transition: Wemay ask your parent/caregiver(if available)to give usinformation about your health, social, and educational history. This survey may take them 10mins to complete, but they will only be asked to complete it once. Measures of Health-Related Quality of Life (HRQL):You may be asked to fill out a one page survey with questions about your physical, emotional, and social well being. This survey will take you no more than 5mins to complete. You may be asked to answer these questions again every 12 months. The TRxANSITION Scale(patient and parent version): You may be asked to answer32 questions related to your health condition knowledge and disease management skills to find out what you know and dont know. A researcher will ask you the questions out loud. Ittakes an average of 7 minutes toanswer all of the questions. You may be asked to answer these questions again 6 months after the first time you answered them and again every 12 months. Mood Face Scale: You may be asked to look atpictures of 9 faces and pick the one that represents how you feel deep down inside. This takes less than 1min to complete. You may be asked to do this at every visit. Medical Passport:Your picture may be taken to createa brief, portable health recordthat isthe size of credit card and contains a summary of your personal health information.This card will include the followinginformation: name, DOB, insurance provider, emergency contact number for hospital, diagnosis(es), allergies, health provider contact numbers, personal emergency contact numbers provided by patient, and medication name, dosage, and purpose.You will be given as many copies of this card as you would like. STARx Transition Readiness Survey: You may be asked to answer 18 questions about how much you feel you know about your health and taking care of yourself, in addition to how ready you feel you are to switch to an adult doctor. Or, if you are already seeing an adult doctor, how easy or hard it was for you to take medical advice from a new doctor. It takes no more than 8mins toanswer allof the questionsand youwill complete it on your own. You may be asked to answer this survey again 6 months after you complete it the first time and then every 12 months after that. The Family Relationship Index: You may be asked to answer 27questions about how well your family gets along, communicates, and supports each other.You would answer these questions on your own and itwould take no more than 7mins to complete. You would only have to answer these questions one time. CES-D : You may be asked to answer 11 questions about how you are feeling. This questionnaire will help to identify symptoms of depression. It will take you no more than 5mins to complete and you may be asked to do this more than once. Medical Passport Usage Survey: If you receive a medical passport, you may be asked to answer questions about whereyou use it, why you use it, and what you think about it. It will take no more than 8mins for you to answer these questions and you will only have to do it once. Patient/Parent Satisfaction Survey: You may be asked to answera brief set of questions about the quality of services you receive from medical staff here. This survey will take no more than 8mins to complete and you may be asked to complete it every 12 months. Morisky 8 item Medication Adherence Scale: You may be asked to answer 4 questions about your medication taking behavior. This will take no more than 2mins and you will only be asked to answer them once. Social Support Questionnaire SSQSR (Short Form-Revised): You may be asked to answer questions about how supported you feel by your peers and family. This questionnaire is completed one time and takes no more than 5mins. Kidney Transplant Knowledge Questionnaire: If you have received a kidney transplant, you may be asked to answer 10 questions about issues and events related to yourtransplant. This questionnaire is completed one time and takes no more than 5mins. The Newest Vital Sign: You may be asked to answer 6 questions about a food label. You will be given a food label to look at while you respond to the questions. This should take no longer than 5mins to complete. You may be asked to do this more than once. Prescription Drug Label: You may be asked to find 5 pieces of information on a prescription label. This will take no longer than 3 mins. You may be asked to do this more than once. PROMIS Anxiety Scale: You may be asked to answer 8 questions about how anxious or nervous you have felt in the past 7 days. This should take no longer than 3 mins and you will only be asked to answer these questions once. PROMIS Depression Scale: You may be asked to answer 8 questions about how sad or depressed you have felt in the past 7 days. This should take no longer than 3 mins and you will only be asked to answer these questions once. PROMIS Peer Relationships: You may be asked to answer 15 questions about your friendships and relationships with people your age. This should take no longer that 7 mins and you will only be asked to answer these questions once. Parental Monitoring Items: You may be asked to answer 6 questions about how much your parent/guardian is involved in your daily life. This should take no longer than 5 mins and you will only be asked to answer these questions once. These questionnaires may help researchers learn more about what can be helpful toyoung peopleas they prepare to change from a pediatric health system to an adult-centered health system.Answering these questionnaires is completely voluntary and you maychoose not tocomplete any questionnaire or answer any questionsat any time.You will be seen only during regularly scheduled clinic appointments.No additional visits/appointments will be required or necessary for participation in this study. What are the possible benefits from being in this study? Research is designed to benefit society by gaining new knowledge. The benefits to you from being in this study may be the possibility ofobtaining a portable method (i.e., medical identification card) to communicate your health information with others wherever you are. You also may benefit from extra education regarding your health condition, medicines, and how to take care of yourself. This will be provided by the Transition Coordinator, doctors, nurses, etc. You will have access to one-on-one time with the Transition Coordinator or research assistant during clinic visits and resource information as needed. If you are eligible to complete certain scales, you may receive compensation up to $15.00. We do not know of any other direct benefits that you will get from being in this study, but your being in the study may help others with the same disease to benefit in the future. What are the possible risks or discomforts involved from being in this study? There is the potential risk that confidential medical information about you may become available to others if you lose your medical identification card. Additionally, the following situations may cause minimal discomfort in participants: when asked to discuss their chronic health condition, discussion of referral to other providers (i.e., mental health, adolescent specialist, etc), discussion of weight and/or healthy eating habits, and possible discussion of sexual activity, and drug/alcohol use, as warranted by patients clinical condition. To minimize discomfort, these issues will be discussed with you in private and your answers will be kept confidential. They will not be disclosed to parents/primary caregivers/legal guardians and will not be shared with doctors/nurses. There may be uncommon or previously unknown risks. You should report any problems to the researcher. How will your privacy be protected? Any personally identifiable information (i.e.,name, date of birth, address, etc) we collect from you will be stored in a password protected database that only the researchersnamed in this study will be permitted access to. Data and information may be shared with other researchers and/or health care providers working with them, but alldata/info will be coded with a unique study ID. Any questionnaire you complete or that is administered to you willhave this ID instead of yourname. The researchers on this study have had training in protecting the privacy and rights of patients. Participants will not be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, -Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies (for example, the FDA) for purposes such as quality control or safety. At some point in time, the researcher(s) may ask you if they can digitally record an interview with you. This digital recording will not contain any personally identifiable information (i.e., name, date of birth, address, etc), only your voice. The recording will only be used to obtain qualitative data. You have the choice of allowing the researcher(s) to record you or not. Please indicate your decision below. Check the line that best matches your choice: _____ OK to record me during the study _____ Not OK to record me during the studyDescribe what will be done with tapes. Additionally, we hope to understand yours and other patients healthcare costs by looking at records of health care visits and the costs of those visits to the system. This will be completed through working with NC TraCS Institute. What if you want to stop before your part in the study is complete? You can withdraw from this study at any time, without penalty. The investigators also have the right to stop your participation at any time. This could be because you have had an unexpected reaction, or have failed to follow instructions, or because the entire study has been stopped Will you receive anything for being in this study? You will not receive anything for being in this study. Will it cost you anything to be in this study? It will not cost you anything to be in this study. Who is sponsoring this study? This research is funded by the Renal Research Institute and the Children's Hospital. This means that the research team is being paid by the sponsor for doing the study. The researchers do not, however, have a direct financial interest with the sponsor or in the final results of the study. What if you have questions about this study? You have the right to ask, and have answered, any questions you may have about this research. If you have questions about the study (including payments), complaints, concerns, or if a research-related injury occurs, you should contact the researchers listed on the first page of this form. What if you have questions about your rights as a research participant? All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If you have questions or concerns about your rights as a research subject, or if you would like to obtain information or offer input, you may contact the Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu.  Participants Agreement: I have read the information provided above. I have asked all the questions I have at this time. 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