Clinical trial: NCT04304950
Section: Alternatives
Subsections: What Other Options Are There?

The only alternative to participating in this study is not to participate. You do not have to participate in this research project in order to receive care and treatment from Rush University Medical Center, and choosing not to participate will not affect your care.
Clinical trial: NCT04304950
Section: Confidentiality
Subsections: What About Confidentiality Of Your Information?

Records of participation in this research study will be maintained and kept confidential as required by law. Each study participant is assigned a code, and his/her data will be entered anonymously into a chart. We will then link the questionnaire and endoscopic results to this data via participant codes. Permission controls and passwords will assure that only the key personnel listed in the IRB review application will be able to enter data into and access the database. All access into the database will be electronically monitored, complete with time and date of access, to ensure security and fidelity of the database material. The database will be stored electronically on a secure server in the PI's office in the Rush Professional Office Building Suite 206 and will be password protected. The database will be saved and maintained for approximately 5 years.  
If you withdraw from this study, the data already collected from may not be removed from the study records. The study doctor and/or study team may ask you whether they can continue to collect follow-up data on you. If follow-up information will be requested, you will be asked to sign a separate consent form before this information can be collected. In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains the ability to use all information collected prior to the revocation of subject authorization. Your identity will not be revealed on any report, publication, or at scientific meetings. In order to conduct the study, the study doctor, Dr. Swanson, **will use and share personal health** information about you. This includes information already in your medical record, as well as information created or collected during the study. Examples of the information that may be shared include your medical history, physical exam and laboratory test results. The study doctor will use this information about you to complete this research. Confidentiality and disclosure of your personal information is further described in the attachment to this form. The attachment is titled HIPAA Authorization to Share Personal Health Information in Research (2 pages). The Rush Institutional Review Board (IRB) will have access to your files as they pertain to this research study. The IRB is a special committee that reviews new and ongoing human research studies to check that the rules and regulations are followed regarding the protection of the rights and welfare of human subjects.
Clinical trial: NCT04304950
Section: Duration of Study Involvement
Subsections: How Many Study Subjects Are Expected To Take Part In The Study?|How Long Will You Be In The Study?

We hope to have a total of 128 subjects enrolled in this study. Participants in this study will be assigned to take the medication they are currently taking in either the morning or in the evening based on when they currently take their medication for 10 weeks +/- 3 days.

You can expect to be in this study for 10 weeks +/- 3 days. You may be removed from this study without your consent. Possible reasons may be that the study doctor decides that continued participation in the study will be harmful to you, you will need a treatment not allowed on the study, your disease becomes worse, you are unable to take the treatment as directed, or the study is canceled.
Clinical trial: NCT04304950
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Possible Risks Of The Study?|Are There Any Anticipated Pregnancy Risks? Women If You Are Pregnant Or Breastfeeding, You Cannot Take Part In This Study. **You Are Responsible For**|Are There Benefits To Taking Part In The Study?|What Happens If You Experience A Research Related Injury?|What Happens If You Need Emergency Care?

We do not foresee any major risks or discomforts associated with this study, as we are not changing the medication or the dose of the medication you currently take. However, the side effects of taking your medication can still apply - with immunomodulators like azathioprine and 6-mercaptopurine - there is a risk of nausea, vomiting, diarrhea, rash, fever, weakness, or muscle pain. Additionally, you will have your blood drawn. There are minimal risks associated with blood draws. Drawing blood involves placing a tight wrap on your upper arm and inserting a needle into a vein in your arm and withdrawing blood. You may experience discomfort at the time of blood draw and/or bleeding, and bruising at the site where the needle enters the body. In rare cases, fainting or infection may occur. To minimize discomfort and local bruising, an experienced nurse or technician will complete the blood draw.

**2 of 5** using an effective birth control method such as birth control pills, barrier method (such as condoms or diaphragms), intrauterine device (IUD), hormone implants or surgical sterility while you are taking part in this study. Once you have completed treatment, you may discontinue birth control. If you become pregnant, you must notify the study doctor immediately.

There may be no direct benefit to you for participating in this study. **However, by participating in**
this study, we may find that there is an optimal time of day for patients to take their prescribed medication in order to best manage IBD symptoms and have a better quality of life. We hope to find that there is a time of day that optimizes the efficacy of the medication and minimizes its side effects.

If you experience any injury or illness as a direct result of your participation in this research study, immediate treatment will be provided. However, the cost of that treatment will be billed to you or your insurance company. Please check with your insurance company regarding coverage. If you have any medical problems during the study, please contact the study doctor. He or she will explain your treatment options to you and/or help you find a place to get treatment. Rush University Medical Center has no program for financial compensation or other forms of compensation for injuries which you may incur as a result of participation in this study.

If you need emergency care while you are participating in this study, it is important that you tell emergency personnel of your participation in this study and notify the study doctor as soon as possible.
Clinical trial: NCT04304950
Section: Procedures
Subsections: What Will You Be Asked To Do?

This study will run for 10 weeks +/- 3 days.  
Part 1: **After you have reviewed this informed consent and signed it, you will be given 6**
questionnaires. These are the Inflammatory Bowel Disease Questionnaire (IBDQ), the Munich Chronotype Questionnaire (MCTQ), the Owl and Lark Questionnaire, the Harvey Bradshaw questionnaire, the RU SATED questionnaire, and a demographics survey. You will be asked to complete these at the time of your first appointment. In addition, a blood draw will be performed to look at certain metabolite levels and other biochemical and subclinical indications of disease. If you currently take - either azathioprine or 6-mercaptopurine - in the morning or the in the evening you will be asked to take your medication during the opposite delivery time for 10 weeks +/- 3 days. If you take it in the morning, you will be asked to take it between 6am-12 pm. If you are assigned to take it in the evening, you will be asked to take it between 6pm-12 am.  
Part 1a: **During the 10 weeks +/- 3 days, as a part of your normal clinical care routine visits, if**
clinically-indicated imaging is necessary, then this data will be collected, too. No imaging will performed outside of what is clinically-indicated.  
Part 2: **During the second appointment you will be given 2 questionnaires. These are the IBDQ**
and Harvey Bradshaw questionnaire. In addition, a blood draw will be performed to look at certain metabolite levels and other biochemical and subclinical indications of disease.
Clinical trial: NCT04304950
Section: Purpose of Research
Subsections: Why Are You Being Invited To Participate In This Study?|What Is The Purpose Of This Study?

You are being asked to take part in this study because you have been identified as a patient at Rush who has Inflammatory Bowel Disease (IBD) and is currently taking either azathioprine or 6-mercaptopurine to manage your symptoms.

The purpose of this study is to see if there are any differences in the efficacy of an IBD medication as well as disease outcomes when one takes their medication for IBD in the morning or in the evening. Each individual has an internal clock that causes their enzyme levels to change at different times during the day. We think that this may have an effect on the efficacy of the medications prescribed for treating IBD, and that there may be a benefit to taking the medication at a certain time of day.