The purpose of this research is to study the efficacy of a technology-based communication and wellness program in reducing negative mental health outcomes for caregivers. This research has important potential consequences for the role of technology in caregiver well-being—a persistent societal issue that tends to be deprioritized.
AI Bots and Wearables for Dementia Caregivers to Improve Quality of Life
Key Information: This summary is provided to help you understand the key elements of this study, as well as the basic reasons why you may or may not wish to consider taking part. This section is only a summary; more detailed information, including how to contact the research team for additional information or questions, is provided under the “Detailed Information” heading.
What should I know about a research study?
Someone will explain this research study to you.
Taking part in the research is voluntary; 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, and can ask questions at any time during the study.
You are invited to take part in a research study. The purpose of this study is to learn about whether and how technological interventions may assist with family caregiving to reduce anxiety, depression, and stress in family caregivers, as well as create a more fulfilling caregiver-care recipient relationship. You are being invited to take part in this research because you are a primary caregiver of a person diagnosed with dementia or mild cognitive impairment.
This research was awarded by Johns Hopkins University and is being funded by National Institute on Aging.
Once enrolled in the study, you will be assigned by chance to one of two groups: a group in which both the caregiver and care recipient wears a watch provided by the research project or the group that does not wear the watch. During the study, you will perform the care of the care recipient as you would normally do and answers five-minute survey contains questions about your week, specifically, emotions and symptoms you have felt. You will listen to the survey questions on your mobile phone and answer by pressing the appropriate key on your phone.
There are no known risks to taking part in this research. There are no benefits to you either. The result from this research will benefit the future development of technologies to enhance caregiver wellbeing. You will receive compensation for participation.
The following is more detailed information about this study, in addition to the information listed above.
Why is this research being done?
The purpose of this research is to study the effectiveness of a technology-based communication and wellness program in reducing negative mental health outcomes for caregivers. This research has important potential consequences for the role of technology in caregiver well-being—a common issue that is often not addressed.
Gene Wang, Brian Hinderberger and Soultana Rouses, who are members of the research team of this study, own stock in the same company that built the system and is paying for this research.
How long will the research last?
Your participation in this research study will last for 16 weeks.
How many people will be enrolled?
Forty care-giver-care-recipient pairs will be enrolled in this research study.
What happens if I say yes, I want to be in this research?
After screening for eligibility and obtaining consent, care recipient-caregiver dyads will be assigned by chance, like the flip of a coin, to either the treatment or the control group. You will have an equal chance of being in the treatment and control group. The size of the treatment and control group will be the same. If you are in the treatment group, both you and your care recipient will wear Apple Watches. You will be guided through the setup process to install the Apple Watch and CareWear apps on your iPhone. You will respond to the wellness-monitoring questions once a week on your phone. Your care recipient is not asked to actively do anything other than to wear the Apple Watch, which will collect location data through GPS. In the control group, neither you nor your care recipient will wear an Apple Watch. You will answer the wellness monitoring questions using an app on your phone. Your care recipient will not be asked to answer any questions. Demographics, such as subjective social class, age, and gender will be collected about you and your care recipient once at the beginning of the study. You will be thanked and compensated at the end of the 16 weeks.
What happens if I do not want to be in this research?
You can choose not to take part in the research and it will not be held against you. Choosing not to take part will involve no penalty or loss of benefit to which you are otherwise entitled. Your alternative to taking part in this research study is not to take part.
What happens if I say yes, but I change my mind later?
You can leave the research at any time and it will not be held against you. If you stop being in the research, already collected data that still includes your name or other personal information will removed from the study record.
Is there any way being in this study could be bad for me?
We do not expect any risks related to the research activities. If you choose to take part and undergo a negative event you feel is related to the study, please contact Gene Wang.
Will I receive anything for being in this study?
This study will take place over the course of a 16-week period. Each week, you will receive $5.00 compensation for 5 minutes of work, for a total possible compensation of $80.00. Both you and your care-recipient will get to keep the apple watch if received for the study. The watches cost $399 each.
Are there any costs for being in this study?
There is no cost to you for being in this study.
There is no charge for the study app that you will put on your cell phone, but you are responsible for the costs associated with the cell phone.
Will being in this study help me in any way?
There are no known benefits to you from your taking part in this research. However, possible benefits to others include designs of future technologies that improve the well-being of care givers.
What happens to the information collected for the research?
Efforts will be made to keep your personal information private, including research study records, with access limited to people who have a need to review this information for study purposes. Your name will be paired with a code number, which will appear on all written study materials. The list pairing your name to the code number will be kept separate from these materials. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the Institutional Review Board (IRB) and other representatives of this organization, as well as collaborating institutions and federal agencies that oversee our research The sponsor of the research the National Institute on Aging may also review research records upon request.
Your data that are collected as part of this research will not be used or distributed for future studies, even if all of your identifiers are removed.
We may share and/or publish the results of this research. However, unless otherwise detailed in this document, we will keep your name and other identifying information confidential.
Can I be removed from the research without my OK?
The person in charge of the research study or the sponsor can remove you from the research study without your approval. Possible reasons for removal include lack of responsiveness to study surveys or inability to install the technology.
Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, you should talk to the research team at 1-844-216-2425 or Gene Wang at firstname.lastname@example.org.
If you have questions regarding your rights as a research participant, or if you have questions, concerns, complaints about the research, would like information, or would like to offer input, you may contact the Sterling Institutional Review Board Regulatory Department, 6300 Powers Ferry Road, Suite 600-351, Atlanta, Georgia 30339 (mailing address) at telephone number 1-888-636-1062 (toll free) or email@example.com.