Evaluating Lifestyle Determinants To Reduce Pouch Inflammation In Patients With Inflammatory Bowel Disease
Principal Investigator: Dr. Katie Dunleavy, MB BCh BAO, Massachusetts General Brigham
• We are asking you to be in a research study.
• The purpose of this study is to find out if lifestyle factors such as diet, physical activity, stress, substance use, sleep and social connectedness may influence J-pouch function and symptoms. If you agree, you will complete a one-time study survey.
• The American College of Gastroenterology is paying for this research to be done.
• We are sharing this study through patient advocacy groups and social media to reach as many patients as we can with a J pouch.
• We are asking you to be in this study because you have inflammatory bowel disease (ulcerative colitis, or Crohn’s disease) and have undergone total proctocolectomy with ileal pouch-anal anastomosis (IPAA) also known as a J pouch. You may be able to join if you:
• are 18 years of age or older
• have had surgery to create an ileal pouch for ulcerative colitis
• are able to give consent and complete study surveys in English
You will not be able to join if you:
• no longer use your pouch because of permanent diversion
• are unable to give consent
• are unable to complete the study questionnaires
• About 150 adults will take part in this study.
• Your survey answers will be kept confidential and will not be associated with your name or other personal identifying information.
• Your de-identified information may be used or shared with other researchers without your additional informed consent.
• The information collected is used for research purposes only, not clinical care.
• The main risks of being in the study are discomfort in answering sensitive and personal questions.
• You will not benefit from taking part in this research study. If you take part in this study, your participation may help people in the future.
• If you decide to take part in this study, we will ask you to sign this consent form before we do any study procedures. During this time you will be asked to complete one-time health and lifestyle questionnaires. Each survey can be completed online and will take about 20–30 minutes to complete online.
These questions will ask about:
• your pouch symptoms and treatments
• your diet and physical activity
• your sleep and stress
• alcohol or other substance use
• your social activities and daily life
• No study medications or procedures are involved. Your usual medical care will not change because of this study. You can skip any question you do not want to answer. Participation is voluntary and you may stop taking part in the study at any time.
• No information will be gathered from other sources such as electronic medical records.
• Deciding not to participate won't affect medical care they receive at Mass General Brigham now or in the future, or any benefits they receive now or have a right to receive.
• Dr. Katie Dunleavy is the Principal Investigator in charge of this research study. You can call her at (617) 726-0267 Monday through Friday from 8:00 am through 4:00 pm. You can also contact the study coordinator Aryan Kumar at 617-229-8149 or email him at akumar91@mgh.harvard.edu Monday through Friday from 8:00 am through 5:00 pm with questions about this research study.
If you want to speak with someone not directly involved in this research study, please contact the Mass General Brigham IRB. You can call them at 857-282-1900.
You can talk to them about:
• A complaint, problem, or concern
• Ask questions, offer input, or obtain information
• Your rights as a research participant
You are agreeing to the collection, use, and sharing of your identifiable information as described in this information sheet. In this study, we may collect identifiable information about you from medical records and from research procedures, including but not limited to research visits, tests, interviews, and questionnaires. Those who may see, use, and share your identifiable information include Mass General Brigham researchers and staff, sponsors of the study and those who the sponsor hires to help perform or audit the research, other researchers, the Mass General Brigham ethics board, groups that oversee the data and safety of this study, non-research staff at Mass General Brigham to conduct their jobs, such as for treatment, payment (billing), or hospital operations, and those hired to conduct work for us, as well as federal and state agencies that oversee, evaluate and audit research, and public health and safety authorities, as noted above.