• Research Consent Form

       

      Study Title: Food is Medicine using Benovate® app

      Investigator: Courtney Jordan Baechler, MD; Minneapolis Heart Institute Foundation

       

      Key Information About This Study

      You are asked to participate in a research study. The purpose of this research study is to determine if the use of a wellbeing site or application known as an ‘app’ (available on a computer or smartphone) will motivate individuals with prediabetes, diabetes, or high blood pressure to make healthier lifestyle choices.

       

      You are being asked to participate in this research study because you have one of the following chronic conditions: prediabetes, diabetes, or high blood pressure. However, if you do not have prediabetes, diabetes or high blood pressure, but would still like to use the app during the six-month duration of the study, you may do so. As an individual without the above-mentioned conditions, the information you enter into the app will not be used as part of the study or the data analysis.

       

      As a participant in this study, you will be asked to create an account with Benovate®. Once your account is created, you will be able to access lifestyle content and asked to answer health and lifestyle questions that are presented to you within the application. In addition, you will be able to take part in short courses on topics that are of interest to you. These short courses will consist of short video clips, information and quizzes related to topics about health, growth, finances, and relationships.

       

      If you are an Allina Health patient, the study team will also collect information about your health condition (pre-diabetes, diabetes, or high blood pressure) from your medical record.

       

      Your access to the app will last for 6 months after enrolling. The study team may collect health information from your health record for up to 6 months after that point.

       

      In order to participate in this study you will need to have access to a desktop computer or a smartphone to create an account and access and use the app.

       

      As with all research, there is a chance that confidentiality could be compromised; however, we take precautions to minimize this risk. Only the information you provide when answering questions within the app will be contained within the app. Your medical record information WILL NOT BE LINKED to the Benovate® application. This study is not intended to treat and/or cure your current condition, however, you may benefit from participating by understanding what factors may impact your health and how to manage them.

       

      Your participation in this study is voluntary. You do not have to participate in this study if you do not want to, or you can stop being in this study anytime. You will not lose any services, benefits, or rights you would normally have if you choose not to participate or stop being in the study.

       

      If you are interested in learning more about this study, read the rest of this form carefully. The information in this form will help you decide if you want to participate in this research or not. The principal investigator of this study is Courtney Jordan Baechler, MD. If you have questions or concerns or want to leave the study, you should let Dr. Baechler know by contacting her at: c.jordan.baechler@mhif.org

       

      If you have any questions about your rights as a volunteer in this research, contact the Allina Health Institutional Review Board Office at 612-262-4920.

       

       

      Why is this research study being done?

       

      We want to learn more about what outside factors influence the lifestyle choices we make. This study will help us learn more about those influences so that health care providers will have a better understanding of how best to guide and educate patients so they can better manage their health in between physician visits.

       

      Why are you being asked to take part in this research study?

       

      You are being asked to participate in this research study because you are over 18 years of age and have one of the following chronic conditions: prediabetes, diabetes, or high blood pressure. If these conditions do not apply to you, you are still able to participate/use the app, but your information will not be analyzed used for purposes of the study. The same is true if you are not an Allina Health patient.
       

      What will happen if you take part in this research?

       

      If you agree to participate, you will:

      • Create an account on the Benovate® website by developing a username and password. To have an account, you must also agree to the Benovate® App Terms & Conditions available in the app, as well as their Platform Privacy Statement. Even though the Terms & Conditions state differently, under an agreement with MHIF, Benovate® will not collect any information about you from other sources, including insurance claims or doctor’s visit information, and will not contact you directly after your use of the app for the study is finished.

      • The app will generate short surveys on topics related to relationships, health, growth and finances. The questions you are asked are personalized according to your interests and needs. There are no right or wrong answers to these questions. You can skip any question you do not want to answer.

      • You will also be given the opportunity to take short informational courses on topics determined by you. These courses could be related to healthy eating, stress management, improving your sleep, physical activity, etc. As you answer questions or participate in courses you will earn points. These points can then be redeemed for coupons from Hy-Vee in New Ulm. The Benovate® app will maintain the points as you accumulate them and the coupons will be generated through your account. A code will then be generated within the app, which you will use at the time of checkout/purchase.

      • Benovate will provide a list of all participants (full name, email, date of birth and application use patterns) to study personnel at the Minneapolis Heart Institute Foundation (MHIF). MHIF will then identify whether participants have active records within the Allina Health system and screen for diagnoses of pre-diabetes, diabetes and high blood pressure. If you have a diagnosis of one of these three conditions, your lab values will be utilized to assess study outcomes.

      How long will you be in this research study?

       

      The study will last approximately one year. You will have use of the app for 6 months and study outcomes will be assessed using information from your medical record (if you are an Allina Health patient) for up to 6 months after study completion. The amount of time you spend within the app is determined by you. We expect to enroll about 1000 individuals in this study with the hope of collecting complete information from about 200 individuals.

       

      What are the possible risks or discomforts from being in this research study?
       

      As with all research, there is a chance that confidentiality could be compromised; however, we take precautions to minimize this risk.

       

      During this study, you will be asked questions related to your health, growth, finances, and relationships. You do not have to answer any question that makes you feel uncomfortable.

       

      What are the possible benefits from being in this research study?

      There is no direct benefit to you. You may learn new strategies to manage your overall wellbeing. It is hoped that the study may help us understand if the app can be used to help encourage patients to make healthier lifestyle choices.

       

      What are the alternatives if you choose not to participate in this research study?

      This study is only being done to gather information. You may choose not to take part in this study. You can stop being in the study at any time.

       

      Will it cost me anything to be in the study?

      No.

       

      Will I be paid for being in the research study?

      No, you will not be paid for your participation. You may earn coupons from your participation to use at

      Hy-Vee New Ulm.

       

      How will the confidentiality of the information collected about you for this research study be maintained?

       

      MHIF is committed to protecting the confidentiality of information obtained about you in connection with this research study. We will safeguard the confidentiality of your data by storing research materials in locked cabinets and password-protecting data stored on computers. Following your use of the Benovate app, MHIF will assign your information a code that is unique to you but does not include information that directly identifies you. Any information collected as a part of this research will have identifiers removed. We will not put your app survey answers into your medical record.

       

      How your information may be shared with others:

       

      While taking part in this study, Benovate will have access to your name, birth date, e-mail address, zip code and the answers to questions you choose to respond to. They will not have access to your medical record information. Once the study is completed, Benovate® will securely store your data for seven years and then destroy it. If the results of this study are made public (for example, through scientific meetings, reports or media), information that identifies you will not be used.

       

      Who will see my information?

       

      The only people allowed to see your information will be the people who work on the study and people who make sure we run our study the right way. Benovate® will have access to the information you put into the software application, however they will not have access to your medical records. Upon completion of the study, Benovate® will share your name with the MHIF study team. This will allow MHIF to match up your name with your medical record information to see if there are any changes in your health outcomes over the course of the study. Persons within Allina Health with responsibilities for the oversight of research may inspect or review records.

       

      What if I have questions?

       

      If you have any questions about the study or feel that you have been injured in any way by being in this study, please contact the study’s primary investigator: Courtney Jordan Baechler at c.jordan.baechler@mhif.org

       

      The Allina Health Institutional Review Board (IRB) has reviewed this research study. If you have any concerns about your rights in this study, please contact the Allina Health IRB at 612-262-4920 or IRB@allina.com.

       

      Your Rights and Permissions

       

      Participation in this study is completely voluntary. You have the right not to participate at all. Even if you decide to be part of the study now, you may change your mind and stop at any time. If at any time you wish to stop your participation or when the study is completed, you may remove the app from your mobile device. When you want to delete the app, please refer to your device’s instructions for how to delete an app. You do not have to check the box (within the app) to indicate your consent, however if you do not, you cannot take part in this research study. Deciding not to participate or choosing to leave the study will not result in any penalty. Saying ‘no’ will not harm your relationship with your own doctors or with MHIF. Identifiers might be removed from the identifiable private information and after such removal, the information could be used for future research studies, or distributed to another investigator for future research without additional informed consent.

       

      If you cancel your permission for MHIF to use or share your health information, your participation in this study will end and no more information about you will be collected; however, information already collected about you in the study may continue to be used. You can cancel your permission for MHIF to use or share your health information at any time by sending a letter to the address below:


      Minneapolis Heart Institute Foundation (MHIF)
      Attn: Courtney Jordan Baechler
      920 East 28th Street, Suite 100
      Minneapolis, MN 55407

       

      We will tell you about any new information that becomes available that might affect your willingness to continue participating in the study. Because the study involves collecting information from your medical record, if you decide to participate you must also authorize the use of your health information as outlined below.

       

      HIPAA AUTHORIZATION FOR USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION

       

      Research Study: Food is Medicine using Benovate® app

       

      Use and Disclosure of Your Health Information

      Your information will be used only in accordance with the provisions of this authorization as outlined in this form or as required by law.

       

      What Information Will Be Used or Disclosed?

      The health information that we may use or disclose (release) for this research includes: all information in a medical record relating to prediabetes, diabetes and/or hypertension as well as all information you provide in response to the surveys in the app.

       

      Who Will Receive, Use, and/or Disclose the Information?

      The following person(s), class(es) of persons, and/or organization(s) may use, receive, and/or disclose the information connected with this study listed below. These persons are authorized to use and disclose the information to the other parties on this list, to you or your personal representative, or as permitted by law.

      · The following health care facilities or research site(s) and research staff involved in this study: Minneapolis Heart Institute Foundation

      · The Office for Human Research Protections in the U.S. Department of Health and Human Services

      · The members and staff of the Institutional Review Board (IRB) that approved this study

      · Principal Investigator: Courtney Jordan Baechler

      · Additional members of the Research Team

      · All persons and entities engaged by the Provider, Allina Health System, or the Research Team to assist in managing, analyzing, storing, or transmitting the information.

      · Personnel within Allina Health System who are responsible for the administration or oversight of research.

      We cannot prevent re-disclosure of your health information by anyone who receives the information under this authorization, and the information may not be covered by state and federal privacy protections after it is released.

       

      How Will the Information be Used and Disclosed?

      Your health information will be:

      · Used and disclosed for purposes of the study, including gathering information for the study, monitoring your safety and the overall safety of the study, and for analyzing study data.

      · Combined with information about other people who participate in the study; and

      · Disclosed to persons listed in this authorization for purposes of the study or as otherwise permitted or required by law.

       

       

      When Access to Your Information May Be Limited

      Your right to access your medical record is not affected by your participation in this project.

      The Notice of Privacy Practices, available in the Minneapolis Heart Institute Foundation where this research is being conducted, provides general information on your rights to review, copy, and correct your health information.

       

      Revocation (cancellation)

      If you decide to end your participation in the study or if you are removed from the study by the principal investigator, you may cancel your authorization to use or disclose your health information by notifying Courtney Jordan Baechler in writing at 920 E. 28th Street, Suite 100, Minneapolis MN, 55407 Your cancellation will be effective after the date it is received. Any health information about you that has already been collected may still be used or disclosed to maintain the integrity or reliability of the research.

       

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