HEP 456 Module 3 Assignment Human Subjects Consent Document   

Name

HEP 456: Health Promotion Program Eval

Arizona State University

Helitzer Irvin

Arizona State University

Research Study Consent

1.      Information Regarding This Study and the Researchers

Study title: Living Well on Dialysis

Principal Investigator:, Student, Arizona State University.

Faculty Advisor: Helitzer Irvin, Dean, Arizona State University

Study Sponsor: American Kidney Foundation.

We’d like your help with a study, and we’ve extended an invitation to you. The information provided here should help you make up your mind about participating in the project. The purpose of the consent form is to confirm that you are aware that this research is an assessment.

1.1 Key Details

Some key details include:

·         The aim of this study is to prevent complications for patients on dialysis and promote long-term healthy habits for patients that have been admitted to Gulfport Memorial Hospital.

·         If you accept to take part in this study, you will be requested to join our team of staff and 149 other new ESRD dialysis patients at the Gulf Memorial Hospital between January 2023 and December 2023. Some of the discomforts of this study include committing lots of time to the program. A time commitment of three hours every Monday, Wednesday, and Friday will be required for the entity of the program, which is 52 weeks. Adoption of healthy eating habits might also be uncomfortable for some time. The program will also involve physical activities like Yoga which might be uncomfortable for a few days for individuals who are not used to physical activity.

·         The direct benefits of this study will be being educated and prepared as a dialysis patient for long-term success during your treatment through a holistic approach to your care which encompasses dietary recommendations, case management, behavioral health services, and other social services.

Participation in this study is completely voluntary. You are under no obligation to take part and may opt out at any moment. Before selecting whether or not to participate in this study, please take the time to read this complete form and ask any questions you may have.

2.      The Purpose of this Study

Seventy percent or more of dialysis patients have high blood pressure, and only around 20% of those with high blood pressure have it well controlled (Sarafidis et al., 2019). Hypertension is also common among those undergoing peritoneal dialysis (PD), with estimates ranging from 30 to 90 percent. Epidemiological studies conducted in Gulfport, Mississippi, indicated that 72%-88% of the dialysis patients examined had high blood pressure (BP), depending on the definition of hypertension (Ashby et al., 2019). The main goal of this project is to prevent complications for patients on dialysis and promote long-term healthy habits for patients who have been admitted to Gulfport Memorial Hospital. The program is expected to improve the health of its participants, reduce the risk of one having complications during dialysis, equip its participants with additional knowledge on how to be on dialysis and still be healthy, and educate its participants on the need for one to take care of their bodies and eating habits.

3.      Who Will Be Part of This Study

3.1 Who can participate in this research?

The priority population for this study will be newly diagnosed ERSD dialysis patients at Gulf Memorial Hospital.

3.2 How many individuals are projected to participate in this study?

The study will encompass a total of 150 newly diagnosed ERSD dialysis patients. In addition, the program will also encompass a total of 15 staff members i.e., a charge nurse, 3 floor nurses, a patient advocate, 3 social workers, a dietician, 5 therapists, and a CHES.

4.      Information Regarding Participation

4.1 What is required of me during this study?

You will first be required to visit the leftwing of Gulf Memorial Hospital, where the program activities will be based. After enrollment, you will be required to commit three hours every Monday, Wednesday, and Friday for the entity of the program, which is 52 weeks. The program will consist of dialysis activities, physical activities, therapy sessions, and education and interaction sessions. Dialysis will take place on the left wing of the Gulfport Memorial hospital, the physical activities will take place on the rooftop, the therapy sessions will take place next to the psychiatric facilities, and the interactions and education will take place in the nurse’s cafeteria.

The Social Workers will be responsible for your arrival to and from the hospital. There will be a sign-in sheet for you to sign in upon arrival at the group counseling session.

4.2 How long will I be participating in this study?

This study will take a total of one year i.e., 52 weeks. You will be required to attend therapy sessions of 3 hours every Monday, Wednesday, and Friday for the entity of the program. After finishing the 1 year program successfully, you will be contacted again in the future for outcome assessment. The evaluation process will take a period of 2 years, so that’s until December, 2025. You should expect to receive evaluation forms up to December 2025. Evaluation will be in the form of questions i.e., interviews as well as medical tests.

4.2.1 When will the participation process end?

The participation will be between January 2023 and December 2023. However, as aforementioned, after finishing the program successfully in December 2023, you will be contacted again in the future for outcome assessment.

4.3 What options can I take if I decide to quit the study before the end?

If you make up your mind not to be part of this study, you will still be able to access treatment from Gulf Memorial Hospital.  Participation is voluntary. If you choose to participate in the program, you will also be automatically legible for participating in the program evaluation.

5.      Study’s Risk and Benefits

5.1 What risks should I anticipate for participating in this project?

The psychological risks that might be witnessed due to the fatigue of attending the therapy sessions will be addressed in the counseling sessions.  The drastic change of diet might also cause some embarrassing bloating and lightheadedness, headaches, and a hangry temper for some individuals. This will be addressed by our program physicians.

5.1.1 What happens if I experience any adverse effects as a result of this study, such as illness or injury??

If you get sick from this experiment, our health experts will link you with Gulf Memorial Hospital for treatment. They’ll help you get medical attention, but your insurer will foot the bill. Participation in this research is voluntary, and your signature here does not waive your right to compensation if you suffer damages as a result of your participation.

5.2 What are the benefits of participating in this study? 

The direct benefits of this study will be being educated and prepared as a dialysis patient for long-term success during your treatment through a holistic approach to your care which encompasses dietary recommendations, case management, behavioral health services, and other social services.

6.      Quitting The Research

6.1 What steps should I take if I want to quit the study?

You’re free to leave the study whenever you choose. If you decide to drop out of the study at any point, you won’t be charged anything. Please contact one of the persons listed in “Contact Information” if you decide to drop out of the study before it’s through. You may also tell the researchers why you’re dropping out, and your responses will be recorded in the study’s data. The researchers will keep the data collected from you for the study until you ask them to delete it. We will be unable to remove your data from the study database if it has already been analyzed by the researchers.

7.      Finances

7.1 Should I expect any kind of payment for participating in this study?

Your time and effort in participating in the research will not be financially compensated. You will only be eligible for any of the stated incentives i.e., 20$ Gift Cards, 20$ BP Curfs, and 15$ Glucose Monitors.

7.1.1 Will I have to incur any cost to be part of this study?

As a participant, you will not incur any costs. The program will also cater to your transportation cost.

7.2 Who stands to gain financially from the study’s findings?

The program will be grant-funded by the American Kidney Fund.

8.      Protecting The Research Information

8.1 How will my information be protected by the researchers?

All data obtained during this study will be securely saved in encrypted electronic files, and all identifying information will be erased from these files after the research is complete.

8.2 Who will have access to my research records?

·         The Institutional Review Board (IRB), ASU, the government, the research’s sponsors or funders, and/or auditors- They may need access to the data to ensure the study is conducted ethically.

·         State/Federal Law-The research team may be obligated to share material with federal or state entities under some circumstances.

8.3 Where will the data from this research go and why?

We will save the information we acquire about you throughout the study for future research initiatives or study records. Your name and other personally identifiable information will be erased from the research data as soon as the study is completed. You may be certain that we will not save any details on you that might be used to track you down, including your name. Findings from the study may be presented or published, but your identity will not be revealed in any way.

8.4 Should I expect my information to be utilized in future studies or shared with other parties?

Your study data may be used or shared in future research investigations. Your information will be de-identified before being shared with other researchers; this means that your name and other identifying details will be removed.

9.      Contact Information

Individuals whom you can contact regarding this study

You may contact the research team if you want to:

·         Learn more about the research project.

·         Ask a question regarding how the research will be conducted.

·         Report if you’re sick, hurt, or have any other issues 

·         Quitting the research before it’s done

·         Expressing concern regarding the study.

Principal Investigator:

Study Cordinator

Email: helitzerirvin@acu.edu

Phone: 504-512-8190

Study Sponsor

Email: americankidneyfoundation@kidney.org

Phone:800-638-8299

If you are a research participant and have issues about your rights, want more details about the research have questions, or want to talk about your concerns with somebody other than the researchers, you may reach out to the following:

Arizona State University

Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS) 1151 S Forest Ave Tempe

AZ 85281 Telephone: 855-278-5080 Fax: 855-278-5080

E-mail: customerservice@asu.edu

10.  Your Consent To Participating In The Study

Participation Consent

If you sign below, you’re giving your consent to take part in this study. Make sure you know why you’re participating in this research before signing anything. We will give you a copy to keep in your file, and we’ll keep a copy in our own records as well. If you have any questions or concerns about the study after having signed this agreement, please get in touch with the research team using the information in Section 9 described above.

I understand the point of the research, and my questions so far have been answered. I accept to participate in this research.

Name:_________________________________________________________

Signature:______________________________________________________

Date:__________________________________________________________

References

Ashby, D., Borman, N., Burton, J., Corbett, R., Davenport, A., Farrington, K., Flowers, K., Fotheringham, J., Andrea Fox, R. N., Franklin, G., Gardiner, C., Martin Gerrish, R. N., Greenwood, S., Hothi, D., Khares, A., Koufaki, P., Levy, J., Lindley, E., MacDonald, J., … Wilkie, M. (2019). Renal Association Clinical Practice Guideline on Haemodialysis. In BMC Nephrology (Vol. 20, Issue 1). https://doi.org/10.1186/s12882-019-1527-3

Sarafidis, P. A., Mallamaci, F., Loutradis, C., Ekart, R., Torino, C., Karpetas, A., … & Zoccali, C. (2019). Prevalence and control of hypertension by 48-h ambulatory blood pressure monitoring in haemodialysis patients: a study by the European Cardiovascular and Renal Medicine (EURECA-m) working group of the ERA-EDTA. Nephrology Dialysis Transplantation, 34(9), 1542-1548.