RESEARCH SUBJECT CONSENT FORM
TITLE: Phase II efficacy study of a technology-enabled care coaching service for families caring for AD/ADRD
PROTOCOL NO.: 1R44AG074778-02
WCG IRB Protocol #20231009
SPONSOR: RSV Opco 5, Inc. (dba KINTO)
INVESTIGATOR:
Joseph T Chung, MS, BS
℅ 225 N. Michigan Ave Fl. 17
Chicago, IL 60601
USA
STUDY-RELATED
PHONE NUMBER(S): (312) 500-8987 (24 hours)
Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.
If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.
RESEARCH CONSENT SUMMARY
You are being asked for your consent to take part in a research study. This document provides a concise summary of this research. It describes the key information that we believe most people need to decide whether to take part in this research. Later sections of this document will provide all relevant details.
What should I know about this research?
● Taking part in this research is voluntary. Whether you take part is up to you.
● If you don’t take part, it won’t be held against you.
● You can take part now and later drop out, and it won’t be held against you.
● If you don’t understand, ask questions.
● Ask all the questions you want before you decide.
● Someone is available to explain this research to you. If you have questions related to this research, please reach out to kintostudy@alz.org or (312) 500-8987
How long will I be in this research?
We expect that your taking part in this research will last 14 weeks.
Why is this research being done?
The purpose of this research, in partnership with the Alzheimer’s Association, is to gather feedback from caregivers about a new caregiver support program that we are developing.
What happens to me if I agree to take part in this research?
Participants will complete an initial survey (Caregiver Survey #1) and then they will be randomly assigned to one of two groups. One group will receive the Care Coaching program (program condition). The other group will not receive the program (control condition).
If you are part of the program condition group, a Care Coach will meet with you via Zoom (an online audio and web conferencing platform) for 60-75 minutes to learn about your caregiving situation and needs, and any financial planning questions you have related to caregiving. Your Care Coach will help you to develop a personalized action plan, and over the following six weeks you will have the opportunity to work with your Care Coach on this plan. You can also participate in up to six virtual support groups (held weekly), with other caregivers who are participating in the study. During the study, you will be asked to complete 3 caregiver surveys. The first will be today, the second will be at the end of the six-week period, and the third will be 45 days after that. The surveys will be 30-45 minutes in duration and will evaluate your caregiving experiences during the study period. You will be asked to download a mobile app on your smartphone that will provide you with additional resources to supplement your Care Coach and support group sessions.
If you are part of the control group, you will not participate in the program described above, but you will be asked to complete the three caregiver surveys. Control group participants will be eligible to attend a free workshop containing content from the Kinto program and will receive information on Alzheimer's Association resources, including local support groups, the Managing Money program, and confidential support and advice through the Helpline.
Could being in this research hurt me?
The most important risks or discomforts that you may expect from taking part in this research include sharing your experiences and emotions with others or hearing or reading about the strong emotions that other caregivers may be experiencing because of their caregiving burdens. There is also a potential for loss of confidentiality.
Will being in this research benefit me?
We cannot promise any benefits to you or others from your taking part in this research. However, possible benefits to you include:
1. obtaining assistance and support through participation in care coaching and peer support group sessions, although this cannot be guaranteed.
2. the opportunity to learn new information related to your caregiving situation and needs.
Will I be paid for being in this research?
Caregivers in the program condition group who complete their initial care coaching session and three caregiver surveys (#s 1, 2 and 3) will receive a $120 VISA gift card following the completion of the third survey.
Caregivers in the control condition group who complete all three caregiver surveys (#s 1, 2, and 3) will receive a $120 VISA gift card following the completion of the third survey.
DETAILED RESEARCH CONSENT
You are being invited to take part in a research study. A person who takes part in a research study is called a research subject, or research participant.
What should I know about this research?
● Taking part in this research is voluntary. Whether you take part is up to you.
● You can choose not to take part. There will be no penalty or loss of benefits to which you are otherwise entitled.
● You can agree to take part and later change your mind. There will be no penalty or loss of benefits to which you are otherwise entitled.
● The investigator has financial interests with the sponsor of this study in the form of private equity.
● If you don’t understand, ask questions.
● Ask all the questions you want before you decide.
● Someone is available to explain this research to you. If you have questions related to this research, please reach out to kintostudy@alz.org or (312) 500-8987.
● This form provides a summary of that explanation.
Why is this research being done?
The purpose of this research is to gather feedback from caregivers about a new caregiver support program that we are developing in collaboration with the Alzheimer’s Association.
About 300 subjects will take part in this research.
How long will I be in this research?
We expect that your taking part in this research will last about 14 weeks.
What happens to me if I agree to take part in this research?
Participants will complete an initial survey (Caregiver Survey #1), which will take 30-45 minutes to complete. Following this, participants will be randomly split into two groups. One group will receive the Care Coaching program (program condition). The other group will not receive the program (control condition).
If you are part of the program condition group, you will be asked to download the Kinto mobile app from the Apple or Google Play Store, and to complete a simple onboarding process (which includes entering your first name, the first name of the person you are caring for, and some basic details about your caregiving situation).
A representative from Kinto will then reach out to schedule a 20-minute call to give you an overview of the Care Coaching program, and answer any questions you may have about the program or the app.
You will then schedule a call with your Care Coach, which will take place via zoom. The Care Coach will work with you to understand what caregiving issues are most important to you, and to discuss key financial topics related to caregiving. Based on this discussion, your Care Coach will help you to establish a personalized action plan that will address your most important goals and issues. Care coaching sessions typically last 60-75 minutes.
In the six weeks following your care coaching session, you will have the opportunity to work with your Care Coach on your action plan. You will have the opportunity to interact with your Care Coach via a chat function in the app, and schedule additional virtual meetings if this is helpful. During this period, you can also – if you would like – participate in up to six virtual support groups with other caregivers, held weekly via zoom.
At the end of the six-week period you will be asked to complete a survey describing your caregiving experiences (Caregiver Survey #2). This survey will probably take about 30-45 minutes to complete. Forty-five days after this, you will be asked to complete a final survey about your caregiving experiences (Caregiver Survey #3).
If you are part of the control group, you will not receive the intervention described above. You will be asked only to complete the three caregiver surveys (#s 1, 2, and 3). After the completion of the study, you will then be eligible to attend a free workshop containing content from the Kinto program and will receive information on Alzheimer's Association resources, including local support groups, the Managing Money program, and confidential support and advice through the Helpline
What are my responsibilities if I take part in this research?
If you are in the program condition group , you will be responsible to:
● Participate in your initial Care Coaching Session
Complete 3 surveys:
o Caregiver Survey #1 (30-45 minutes)
o Caregiver Survey #2 (30-45 minutes)
o Caregiver Survey #3 (30-45 minutes)
If you are in the control group, you will be responsible to:
Complete 3 surveys:
o Caregiver Survey #1 (30-45 minutes)
o Caregiver Survey #2 (30-45 minutes)
o Caregiver Survey #3 (30-45 minutes)
Could being in this research hurt me?
Being a part of this research could result in:
● Psychological risk - During this study you may be asked to share experiences, express emotions or may hear or read communications from other caregivers who occasionally express strong emotions and/or reactions which you may find upsetting.
● Privacy risk – If asked to use the Kinto app to communicate with your Care Coach and/or support group, it may involve sharing personal information, which could be maliciously obtained if the Kinto app’s security and privacy protocols were breached or if others share information they learn about you. To mitigate this risk, the project team has implemented policies, procedures, and infrastructure that meet or exceed industry standards for this type of study.
● In addition to these risks, taking part in this research may harm you in unknown ways.
Overall, the risks of participating in this study are minimal.
Will it cost me money to take part in this research?
For the intervention group, the research involves using a mobile app and may result in charges from your mobile plan provider for use of data.
Will being in this research benefit me?
We cannot promise any benefits to you or others from your taking part in this research. However, possible benefits to you include:
1. Obtaining assistance and support through participation in peer support group sessions
2. The opportunity to learn new information related to your caregiving situation and needs.
What other choices do I have besides taking part in this research?
This research is not designed to diagnose, treat or prevent any disease. Your alternative is to not take part in the research.
What happens to the information collected for this research?
Your private information will be shared with individuals and organizations that conduct or watch over this research, including:
● The research sponsor, Kinto
● People who work with the research sponsor (including the Alzheimer’s Association)
● Government agencies, such as the U.S. Food and Drug Administration (FDA) and National Institutes of Health
● WCG IRB, the Institutional Review Board (IRB) that reviewed this research
We may publish the results of this research. However, we will keep your name and other identifying information confidential.
We protect your information from disclosure to others to the extent required by law. We cannot promise complete secrecy. We will not maintain as confidential information about known or reasonably suspected incidents of abuse or neglect of a dependent adult or elder, including, but not limited to, physical, sexual, emotional, and financial abuse or neglect. If any researcher has or is given such information, they may be required to report it to the authorities.
Who can answer my questions about this research?
If you have questions, concerns, or complaints, or think this research has hurt you or made you sick, talk to the research team at the phone number listed above on the first page.
This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com if:
● You have questions, concerns, or complaints that are not being answered by the research team.
● You are not getting answers from the research team.
● You cannot reach the research team.
● You want to talk to someone else about the research.
● You have questions about your rights as a research subject.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Can I be removed from this research without my approval?
The person in charge of this research can remove you from this research without your approval. Possible reasons for removal include:
● It is in your best interest
● You are unable to keep your scheduled appointments
● You need support not covered in this research
● The research is canceled by the FDA or the sponsor
● If you are abusive to your Care Coach or Peer Group members, or unduly monopolize peer support group meetings
We will tell you about any new information that may affect your health, welfare, or choice to stay in this research.
What happens if I agree to be in this research, but I change my mind later?
If you decide to leave this research, contact your Care Coach or kintostudy@alz.org so that the investigator can be notified of your decision. Kinto will cancel any scheduled care coaching sessions, terminate your account on the caregiver mobile app, and email you to let you know that this has been done. No further action will be required on your part.
Will I be paid for taking part in this research?
Caregivers in the program condition group who complete their initial care coaching session and the three caregiver surveys (#s 1, 2 and 3) will receive a $120 VISA gift card following the completion of the third survey.
Caregivers in the control condition group who complete all three caregiver surveys (#s 1, 2, and 3) will receive a $120 VISA gift card following the completion of the third survey.
Statement of Consent:
Your signature documents your consent to take part in this research.
I have read the information in this consent form (or it has been read to me). All my questions about the study and my participation in it have been answered. I freely consent to be in this research study.
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH PURPOSES
What information may be used and given to others?
The study doctor will get your personal and medical information. For example:
● Past and present medical records
● Research records
● Records about phone calls made as part of this research
● Records about your study visits.
Who may use and give out information about you?
The study doctor and the study staff.
Who might get this information?
The sponsor of this research. “Sponsor” means any persons or companies that are:
o working for or with the sponsor, or
o owned by the sponsor.
Your information may be given to:
· The U.S. Food and Drug Administration (FDA),
· Department of Health and Human Services (DHHS) agencies,
· Governmental agencies in other countries,
· Governmental agencies to whom certain diseases (reportable diseases) must be reported, and
· WCG IRB.
Why will this information be used and/or given to others?
· to do the research,
· to study the results, and
· to make sure that the research was done right.
If the results of this study are made public, information that identifies you will not be used.
What if I decide not to give permission to use and give out my health information?
Then you will not be able to be in this research study.
May I review or copy my information?
Yes, but you will have access to your general information only after the research is over. You have the right to review any mental health information collected about you and shared with others.
May I withdraw or revoke (cancel) my permission?
This permission will be good until December 31, 2070.
You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to stay in this study.
When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others.
Is my health information protected after it has been given to others?
There is a risk that your information will be given to others without your permission.