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CONNECT-HF

Study Title: A Canada-wide qualitative study of social connections in patients with early onset heart failure (“CONNECT-HF”)

OHSN-REB Number: 20260072-01H

Principal Investigator: Dr. Karen Bouchard, Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, Canada.

Funder(s): Brain-Heart Interconnectome Exploration Grant

INTRODUCTION

You are being invited to participate in a research study. You are invited to participate in this research study because you have a self-declared status as an individual with diagnosed heart failure (HF; Any New York HF class); you are under the age of 55 (men) or 65 (women); you live in Canada; and you can read and understand English or French.

Please take your time in making your decision. You may find it helpful to discuss it with your friends and family.

Taking part in this study is voluntary. You have the option not to participate at all or you may choose to leave the study at any time. Whatever you choose, it will not affect the usual medical care that you receive outside the study.

If you are a First Nations or an Indigenous person, you may want to talk to an Elder before you make a decision about this research study.

WHY IS THIS STUDY BEING DONE?

The purpose of this study is to improve understanding of how social connections shift when younger and middle-aged adults are diagnosed and living with heart failure. The goal of the study is to develop an evidence-informed program, resource, or activity that will improve feelings of connection amongst patients with heart failure.

IS THERE A CONFLICT OF INTEREST?

The University of Ottawa Heart Institute (UOHI) is receiving financial payment from Brain-Heart Interconnectome (BHI) to cover the cost of conducting this study.

HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?

It is anticipated that about 30 people will take part in this phase of the study, from Canada. This study should take six months to complete, and the results should be known in about eleven months.

WHAT WILL HAPPEN DURING THIS STUDY?

This is a qualitative research study involving online questionnaires and an individual interview.

You will be first asked to complete a series of online questionnaires which must be completed prior to the interview. The online questionnaires include a sociodemographic questionnaire and short questionnaires measuring loneliness, social support, social isolation, and your comorbidities (i.e., other health conditions that you have). The questionnaires will take about 10 minutes to complete. If you choose to participate and provide verbal consent, a link to the questionnaires will be sent to you your email address for you to complete online. Even though you may have provide basic medical information on the sociodemographic and basic health questionnaire, these responses will not be reviewed promptly by your physician/healthcare team. If you wish them to know this information, please bring it to their attention. Additionally, other than the sociodemographic questionnaire which will be available in French, all other questionnaires will be available in English only.

If you are French speaking and are not comfortable with completing the questionnaires in English, kindly reach out to the research team to discuss this concern. Upon doing so, you will be given the option to skip those specific questionnaires.

After the series of questionnaires, you will then be asked to participate in an interview. During the interview, you will meet two members of the research team, one of whom is a patient partner with lived experience of heart failure who is external to the University of Ottawa Heart Institute. The date and time of the interview will be decided mutually by you and the interviewing team. Each interview will be about 60 minutes long and will take place via Microsoft Teams. The interview will include broad questions that will help us understand your social connections with your spouse, family, friends, coworkers, and broader communities, and how these connections are influenced by heart failure. We are interested in learning about the number of relationships you have, how often or how long you interact with others, whether you feel alone, the type of support you experience, and the quality of your interactions.

The information you provide in the interview and the questionnaires are for research purposes only. Some of the questions are personal. You can choose not to answer questions if you wish.

You will be audio recorded during the Microsoft Teams interview, which will be transcribed by the Microsoft Teams software and quality checked by members of the research team. Once the transcription has been completed and verified for accuracy, the audio recording will be deleted.

HOW LONG WILL PARTICIPANTS BE IN THE STUDY?

Your participation in this study will require you to fill out a brief 10 minute online sociodemographic and health questionnaire and participate in an interview for about 60 minutes.

CAN PARTICIPANTS CHOOSE TO LEAVE THE STUDY?

You can choose to end your participation in this research (called withdrawal) at any time without having to provide a reason. If you choose to withdraw from the study, you are encouraged to contact the research team.

You may withdraw your permission to use information that was collected about you for this study at any time by letting the research team know. However, this would also mean that you withdraw from the study.

CAN PARTICIPATION IN THIS STUDY END EARLY?

Your participation in the study may be stopped early, and without your consent, for reasons such as:

The research team has decided to stop the study
The Ottawa Health Science Network Research Ethics Board withdraws permission for this study to continue

If you are removed from this study, the research team will discuss the reasons with you.

WHAT ARE THE RISKS OR HARMS OF PARTICIPATING IN THIS STUDY?

There are no medical risks to you from participating in this study. It is possible that you may become uncomfortable while discussing your experiences. You may choose not to answer questions or leave the interview at any time if you experience any discomfort.

WHAT ARE THE BENEFITS OF PARTICIPATING IN THIS STUDY?

There are no benefits to you for taking part in this study. You may not receive direct benefit from participating in this study. We hope the information learned from this study will help other people with heart failure in the future.

HOW WILL PARTICIPANT INFORMATION BE KEPT CONFIDENTIAL?

If you decide to participate in this study, the research team will only collect the information they need for this study. Records identifying you will be kept confidential and, to the extent permitted by the applicable laws, will not be disclosed or made publicly available, except as described in this consent document.

Authorized representatives of the following organizations may look at your original (identifiable) records at the site where these records are held, to check that the information collected for the study is correct and follows proper laws and guidelines.

The Ottawa Health Science Network Research Ethics Board who oversees the ethical conduct of this study.
Ottawa Heart Institute Research Corporation, the Sponsor of this study, who oversees the conduct of research at this location.

Information that is collected about you for the study (called study data) may also be sent to the organizations listed above. Your name, address, email, or other information that may directly identify you will not be used. The records received by these organizations may contain your participant ID, the first three digits of your postal code, sex/gender, partial date of birth (month/year), race/ethnicity, and information from your medical history.

This research study is collecting information on race and ethnicity as well as other characteristics of individuals because these characteristics may influence how individuals experience social connections and support after being diagnosed with and living with heart failure. Providing information on your race or ethnic origin is voluntary, and you can choose not to answer these questions.

This study requires the transfer of identifiable information to Patient Partner’s Jenny Milne and Jackie Ratz for the purposes of conducting qualitative interviews. Patient Partners will sign confidentiality agreements to ensure the privacy and protection of your information. The following information will be shared:

Name
Email (displayed on MS teams)
Any information shared during the interview

Communication via e-mail is not absolutely secure. We do not recommend that you communicate sensitive personal information via e-mail.

During the interview discussions, you will be encouraged to refrain from using names. If names or other identifying information are shared during the discussion, they will not be included in the written records.

The audio recordings will be stored in a secure location and accessed only by members of the research team. The recordings will be kept until they have been transcribed (turned into written records) by Microsoft Teams and quality checked by a member of the research team. Following this, they will be destroyed. Transcribed data will be de-identified (e.g., names of people and places removed) and then uploaded to Delve, a qualitative data analysis software, for data analysis.

If the results of this study are published, shared, or presented at scientific meetings, your identity will remain confidential. It is expected that the information collected during this study will be published and presented to the scientific community in journals and conference proceedings. De-identified questionnaire data may also be shared in an open science repository (Open Science Framework [OSF]) to support transparency and future research. No information that could identify you will be included in these shared data.

WHAT IS THE COST TO PARTICIPANTS?

Participation in this study will not involve any additional costs to you or your private health care insurance.

ARE STUDY PARTICIPANTS PAID TO BE IN THIS STUDY?

Upon completion of the interview and questionnaires, you will receive a $50 gift card to Shoppers Drug Mart, provided to you via email.

WHAT ARE THE RIGHTS OF PARTICIPANTS IN A RESEARCH STUDY?

You will be told, in a timely manner, about new information that may be relevant to your willingness to participate in this study.

You have the right to be informed of the results of this study once the entire study is complete. If you would like to know the results of the study, please let the study team know during the interview.

Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected.

WHOM DO PARTICIPANTS CONTACT FOR QUESTIONS?

In case you have any questions, here are some contact numbers that are good to have. Do you have a pen and paper ready?

If you have questions about your rights as a participant or about ethical issues related to this study, you can talk to someone who is not involved in the study at all. Please contact The Ottawa Health Science Network Research Ethics Board, Chairperson at 613-798-5555 extension 16719, or at rebadministration@toh.ca.

I can answer any questions that you may have about the research study right now, but if you think of additional questions later on, you can contact Dr. Karen Bouchard at 613-696-7000 x 10998.