QoL Tool – Consent

Quality of life in Bipolar Disorder: e-health engagement to move evidence into action

Principal Investigator:
Erin E. Michalak, Ph.D., Department of Psychiatry, University of British Columbia, (604) 827-3393

Co-Investigators:
Daniel Bilsker, Ph.D., R.Psych., Department of Psychiatry, University of British Columbia, (604) 682-1909
Greg Murray, Ph.D., Department of Psychological Sciences and Statistics, Swinburne University of Technology (Australia), +61 3 9214 8300
Victoria Maxwell, Crazy for Life Co., (604) 887-7645

Sponsor:  Canadian Institutes of Health Research (CIHR)

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Introduction
You are being invited to take part in a research study because you describe yourself as having a diagnosis of bipolar disorder. Please read this explanation about the study and its risks and benefits before you decide if you would like to take part. You should take as much time as you need to make your decision. You should ask the study staff to explain anything that you do not understand and make sure that all of your questions have been answered before signing this consent form. Before you make your decision, feel free to talk about this study with anyone you wish. Participation in this study is voluntary.

Background and Purpose
Bipolar disorder (BD) is a common and often disabling mood disorder. Historically, when we have assessed outcomes in BD we have tended to measure clinical outcomes, such as rates of relapse or degree of symptom reduction. More recently we have seen the uptake of other forms of outcome assessment in clinical settings, such as the measurement of quality of life. Our research team has developed a condition-specific scale to measure quality of life in BD, the Quality of Life in Bipolar Disorder tool (Quality of Life tool), which has now been developed into an online version that can be widely used by people with BD.

Please note: This is a research study and is not intended to provide a medical diagnosis or treatment.

Participant Inclusion Criteria
You may participate in this study if you:

  1. are aged 19 or above
  2. have a diagnosis of bipolar disorder (type I, II or NOS)

Study Procedures
If you agree to take part in this study, the procedures you can expect will include the following:

Participation in this study is completely voluntary. You can expect to take the Quality of Life tool, which is an Internet-based resource to measure quality of life. The Quality of Life tool is a 56 item online questionnaire that should take you between 5 and 10 minutes to complete. By creating a user account for the tool you will be able to track your results over time.

Potential Risks
There are no risks or inconveniences anticipated in terms of participating in this study. Your participation in this study will have no direct impact on your current or future treatment and care for BD, or your relationship with UBC.

Potential Benefits
You may or may not benefit from this study. You may gain more knowledge and awareness about your own quality of life with BD, but no benefits are guaranteed. You will not receive any profits, legal entitlements, or other commercial benefits from the development of the QoL.BD scale.

Confidentiality
Your personal information will be respected and kept confidential. The Quality of Life tool data is hosted on a secure server located in the UBC Department of Psychiatry. All printed documents will be identified by code numbers and kept at UBC in a locked filing cabinet with limited access. You will not be identified by name in any reports or products of the completed study. Unidentified (anonymous) data from this study may be combined with data from other studies in order to present findings from a larger group of participants.

Remuneration
You will not be paid for allowing your Quality of Life tool data to be used in this study.

Voluntary Participation/Ability to Withdraw
Your participation in this study is entirely voluntary. You may exit the Quality of Life tool at any time and are under no obligation to return.

At a later date, you might be invited to participate in additional activities to evaluate future aspects of the Quality of Life tool. Please note that your participation in this study does not oblige you to participate in future evaluations. However, if you are interested in further participation, please see the optional consent at the end of this form.

Summary of Research Results
Any published results of these studies will be found on our website, the Collaborative RESearch Team to study psychosocial issues in Bipolar Disorder (https://www.crestbd.ca). All research articles will also be deposited in the open-access website PubMed Central Canada (http://pubmedcentralcanada.ca).

Conflict of Interest
There are no known actual, apparent, potential, or perceived conflicts of interest in conducting this study.

Questions or Concerns About the Study
If you have any questions, concerns, or would like any further information about this study, please contact the Research Coordinator by phone at (604) 822-7247, or by email at crest.bd@ubc.ca. If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the UBC Office of Research Ethics at 604-822-8598 or if long distance e-mail RSIL@ors.ubc.ca or call toll free 1-877-822-8598. This office is not part of the study team. Everything that you discuss will be kept confidential. The Ethics ID number for this study is H13-00976.

Consent: Quality of Life in BD Tool Data
You consent to participate in this study by fully reading this form and clicking YES to “I consent to include my data in research” on the Quality of Life tool website. By clicking NO you may continue on to the tool without including your data in our research.

  • I have read and understood the subject information and consent form of this study.
  • I freely consent to participate in this study.
  • I have had sufficient time to consider this information and to ask for advice if necessary.
  • I have had the opportunity to ask questions and have had satisfactory responses.
  • I understand that my identity will be kept strictly confidential and that the information collected will only be used for scientific objectives.
  • I understand that my participation in this study is voluntary and that I am completely free to refuse to participate or to withdraw from this study at any time without changing in any way the quality of care that I receive.
  • I understand that I am not waiving any of my legal rights by signing this consent form.
  • I understand that there is no guarantee that this study will provide any benefits to me.
  • I understand that I will receive a dated and signed copy of this form to keep for myself.
  • I understand that this is a research study and will not provide medical diagnosis or treatment.

Please return to the Quality of Life tool site to provide your consent. Thank you!