IMPLIED CONSENT LETTER

Study title: Tess – A Digital Health Companion for Older Adults

WHAT WE ARE INVITING YOU TO DO:

As described above, Tess is a chat bot that delivers mental health support using an integrative approach, which aligns with the more natural style demonstrated by clinicians when tailoring interventions to best meet client needs. There are a variety of emotion categories that allow Tess to deliver personalized support based on each person’s unique concerns. Developed by mental health and medical professionals, Tess delivers interventions rooted in cognitive based therapy, grief counseling, psychodynamic therapy, resilience-building strategies, general wellness, communication strategies, and other mood boosting tips. For this study, Tess’ primary focus is to support older adults in coping with social isolation and loneliness.

This study is being conducted by Drs. Paul Holyoke and Heather McNeil from the SE Research Centre and is funded by the Centre for Brain Health and Aging Innovation.

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IS PARTICIPATION IN THE STUDY VOLUNTARY?

Your participation in the study is completely voluntary. You may decline to answer any question(s) you prefer not to answer and still remain in the study. Participants will be free to withdraw from the study at any time without penalty. Any data (e.g. conversations, survey data) collected prior to the participant’s withdrawal from the study or in anonymized form received from X2ai, Inc., will be deleted and not used.

RISKS AND BENEFITS:

There are no known or anticipated risks associated with participation in this study. Please see the section about voluntary participation for more details. Information gathered through this this study may help to develop a better understanding of how individuals interact with technology, and what improvements can be made for the future.

[Text message participants and voice-enabled natural language device who already own device]: To thank you for giving up your valuable time to help out on this study, you receive a $10 pre-paid Amazon e-gift card.  

[Participants using a voice-enabled natural language device who do not have either an Amazon Dot or Google Home device]: To thank you for giving up your valuable time to help out on this study you will be provided with either of an Amazon Dot or Google Home device.

WILL MY IDENTITY BE KNOWN TO OTHERS?

If you agree to participate in the study, de-identified data will be sent from X2ai Inc. to researchers at SE Health using a random, unique identification number. Any study results which are reported will not identify you by name or contain any identifiable information.

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WILL THE INFORMATION I PROVIDE TO THE RESEARCHERS BE KEPT CONFIDENTIAL?

All study team members are committed to confidentiality and non-disclosure to protect the information you and others share during this project. All members of the research team have completed the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Tutorial, which is mandatory for all researchers. All aspects of the study will be confidential and only the investigators and research staff will have access to information collected. Electronic data will be stored on secure servers owned by X2Ai Inc. and SE Health, which comply with the standards of the Personal Health Information Protection Act. All records will be securely destroyed within 7 years.

ETHICS REVIEW

This study has been reviewed by the Southlake Regional Health Centre Research Ethics Board. If you have any questions regarding your rights as a study participant or about ethical issues related to this study, please contact the Chair of the Ethics Board, Dr. Pravesh Jugnundan, at 905-895-4521 ext. 6638.

WHO SHOULD I CONTACT IF I HAVE QUESTIONS REGARDING THIS STUDY?

If you have any questions regarding this study or would like additional information to assist you in reaching a decision about participation, please contact Karthika Yogaratnam, Research Associate from the SE Research Centre, by phone at 647-326-4578 or by email at KarthikaYogaratnam@sehc.com.