Title of Research Study: D2D Blood Pressure on a Stick
Investigator Team Contact Information: Ann Philbrick, PharmD, FCCP, BCPS, BCACPFor questions about research appointments, the research study, research results, or other concerns, call the study team at:
Investigator Name: Ann Philbrick Investigator Departmental Affiliation: Dept of Pharmaceutical Care and Health Systems & Dept of Family Medicine and COmmunity Health Phone Number: (651) 227-6551
Email Address: philb020@umn.edu Study Staff (if applicable): Phone Number: Email Address:
Supported By: This research is supported by the University of Minnesota Medical School, Department of Family Medicine and Community Health Discovery Fund, M Health Fairview – Bethesda Clinic, and UMN College of Pharmacy.
Key Information About This Research Study
The following is a short summary to help you decide whether or not to be a part of this research study. More detailed information is listed later on in this form.
What is research? Doctors and investigators are committed to your care and safety. There are important differences between research and treatment plans:
The goal of research is to learn new things in order to help groups of people in the future. Investigators learn things by following the same plan with a number of participants, so they do not usually make changes to the plan for individual research participants. You, as an individual, may or may not be helped by volunteering for a research study. The goal of clinical care is to help you get better or to improve your quality of life. Doctors can make changes to your clinical care plan as needed. Research and clinical care are often combined. One purpose of this informed consent document is to provide you clear information about the specific research activities of this study.
Why am I being asked to take part in this research study?
We are asking you to take part in this research study because you are 18 years old and above, have been told by your primary care physician that you have hypertension, and are not pregnant (if female).
What should I know about a research study?
Someone will explain this research study to you. Whether or not you take part is up to you. You can choose not to take part. You can agree to take part and later change your mind. Your decision will not be held against you. You can ask all the questions you want before you decide. Why is this research being done?
The purpose of this study is to determine to what extent, if any, fifteen minute Office Blood Pressure Monitoring (OBP-15) lowers blood pressure in a diverse state fair population. Research has shown that OBP-30 is about the same as a typical daytime blood pressure. The trouble with this method is that it takes a lot of time that may not work in a typical medical office setting. We want to see if we reduce the time to 15 minutes, we may be able to see a similar drop in blood pressure. A potential benefit is that you may receive a more accurate blood pressure reading.
How long will the research last?
We expect that you will be in this research study for just this one time period. Participation will take approximately 20 minutes (5 minutes consent and brief survey,15 minutes OBP-15).
What will I need to do to participate?
You will be asked to review this consent form and ask any questions you may have, complete a brief survey, and sit relaxed while your blood pressure is being taken consecutively four times, 5 minutes apart from each other for a total of 15 minutes.
More detailed information about the study procedures can be found under “What happens if I say yes, I want to be in this research?”
Is there any way that being in this study could be bad for me?
The risk for participating in this study is minimal. There may be slight discomfort when taking blood pressure measurements, but nothing more than what you would experience taking your blood pressure during regular clinical care.
Will being in this study help me in any way?
We cannot promise any benefits to you or others from your taking part in this research. However, possible benefits include having a more accurate reading of your blood pressure.
What happens if I do not want to be in this research?
There are no known alternatives, other than deciding not to participate in this research study.
Detailed Information About This Research Study
The following is more detailed information about this study in addition to the information listed above.
How many people will be studied?
We expect about 125 people here will be in this research study.
What happens if I say “Yes, I want to be in this research ”?
If you say, “Yes, I want to be in this research”, the research staff will review this consent form with you and you will complete a brief survey (5 minutes). Then, we will have you sit relaxed and take your blood pressure measurements four times, 5 minutes apart (total of 15 minutes). Participation in this study will be just this one time with no follow up.
What happens if I say Yes, but I change my mind later?
If you take part in this research study, and want to leave, you should tell us. It is your choice not to be in this study. We will make sure that you stop the study safely. We will also talk to you about follow-up care, if needed.
Will it cost me anything to participate in this research study?
Taking part in this research study will not lead to any costs to you.
What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of your personal information, including research study and medical records, to people who have a need to review this information. We cannot promise complete confidentiality. Organizations that may inspect and copy your information include the Institutional Review Board (IRB), the committee that provides ethical and regulatory oversight of research, and other representatives of this institution, including those that have responsibilities for monitoring or ensuring compliance (such as the Quality Assurance Program of the Human Research Protection Program (HRPP)).
Will I receive research test results?
Most tests done on samples in research studies are only for research and have no clear meaning for health care. We will share your individual blood pressure readings with you after your participation in the study.
What will be done with my data when this study is over?
Your data will not be used for any future research after this study is complete.
Will anyone besides the study team be at my consent meeting?
You may be asked by the study team for your permission for an auditor to observe your consent meeting. Observing the consent meeting is one way that the University of Minnesota makes sure that your rights as a research participant are protected. The auditor is there to observe the consent meeting, which will be carried out by the people on the study team. The auditor will not document any personal (e.g. name, date of birth) or confidential information about you. The auditor will not observe your consent meeting without your permission ahead of time.
Whom do I contact if I have questions, concerns or feedback about my experience?This research has been reviewed and approved by an IRB within the Human Research Protections Program (HRPP). To share feedback privately with the HRPP about your research experience, call the Research Participants' Advocate Line at 612-625-1650 (Toll Free: 1-888-224-8636) or go to z.umn.edu/participants . You are encouraged to contact the HRPP if:
Your questions, concerns, or complaints are not being answered by the research team. You cannot reach the research team. You want to talk to someone besides the research team. You have questions about your rights as a research participant. You want to get information or provide input about this research. Will I have a chance to provide feedback after the study is over? The HRPP may ask you to complete a survey that asks about your experience as a research participant. You do not have to complete the survey if you do not want to. If you do choose to complete the survey, your responses will be anonymous.
If you are not asked to complete a survey, but you would like to share feedback, please contact the study team or the HRPP. See the “Investigator Contact Information” of this form for study team contact information and “Whom do I contact if I have questions, concerns or feedback about my experience?” of this form for HRPP contact information.
UMN IRB
Effective on 7/06/2021
IRB Study Number: STUDY00013142
I agree to participate in this research.
Yes
No