THE UNIVERSITY OF BRITISH COLUMBIA AND SIMON FRASER UNIVERSITY ACTIVE AGING BC: CHOOSE TO MOVE Participant Information and Consent Form Principal Investigator: Heather McKay, PhD Professor, Depts. of Orthopaedics & Family Practice, Faculty of Medicine, University of British Columbia Director, Centre for Hip Health and Mobility Contact: Christa Hoy, MSc Research Manager, Centre for Hip Health and Mobility University of British Columbia 604-675-2581 Co-investigators: Heather MacLeod-Williams, MPE Program Director, Choose to Move Centre for Hip Health and Mobility University of British Columbia 604-875-4111 ext.52582 Dawn Mackey, PhD Assistant Professor, Biomedical Physiology and Kinesiology, Simon Fraser University Investigator, Centre for Hip Health and Mobility Joanie Sims-Gould, PhD, RSW Assistant Professor Dept. of Family Practice, Faculty of Medicine, University of British Columbia Investigator, Centre for Hip Health and Mobility Maureen C. Ashe, PhD, PT Associate Professor Department of Family Practice, University of British Columbia Investigator, Centre for Hip Health and Mobility Meghan Winters, PhD Assistant Professor Faculty of Health Sciences, Simon Fraser University Investigator, Center for Hip Health and Mobility Sponsors: This research is supported by the Centre for Health and Mobility Society. Page 1 of 8 Version Date: 08-12-2015 Introduction You are being invited to take part in this research study because you meet the study’s eligibility criteria. Your participation in this research study is entirely voluntary, so it is up to you to decide whether or not to take part in this research study. Before you decide, it is important for you to understand what the research study involves. This consent form will tell you about the program, why the research study is being done, what will happen to you during the research study, and the possible benefits, risk and discomforts. If you wish to participate, you will be asked to sign this form. If you decide to take part in this research study, you are still free to withdraw at any time and without giving any reasons for your decision. You may also ask to have all your data withdrawn as well should you choose to withdraw. If you do not wish to participate, you do not have to provide any reasons for your decision nor will you lose the benefit of participating in the Choose to Move program. Please read the following information carefully before you decide. Who is conducting this research study? Researchers from the University of British Columbia, Simon Fraser University, and the Centre for Hip Health and Mobility are conducting the research, sponsored by the Centre for Health and Mobility Society. The Principal Investigator is Dr. Heather McKay from the University of British Columbia and the Centre for Hip Health and Mobility. What is the purpose of the research study? The primary purpose of this research study is to better understand the implementation of Choose to Move: a choice-based physical activity program for older adults. In our research of Choose to Move we will study the reach of the programs, context the programs are delivered in, capacity built and impact on program participants’ physical activity, sitting time, mobility, active transport and social connectedness. We will conduct the research study at baseline, 3-months (end of active phase) and 6-months (end taper phase). Who can participate in this research study? You can participate in this research study if you are: A Choose to Move program participant, are 60 or older, and demonstrate readiness for physical activity (by the PAR-Q+ questionnaire or a letter of recommendation from your physician) Who should not participate in this research study? You should not participate in this study if you: Cannot read or speak English Are unable to provide informed consent Page 2 of 8 Version Date: 08-12-2015 What does the research study involve? 1. Baseline Assessment At the first group meeting, your activity coach will review this document with you and address any concerns or questions you may have. You will then be provided with the opportunity to give your informed consent to participate in the research study. If you agree to participate, we will gather the following general information via questionnaire: age category, sex, weight, height, mobility, ethnicity, education level. We will also ask you to share how you heard about Choose to Move. We will gather information in a survey about physical activity, sitting time, active transport, social exclusion, social interaction and loneliness. This will require approximately 15 minutes of your time, but will be a part of the normal group meeting. This information will be collected again at 3-month and 6-month assessments. Studies involving humans now routinely collect information on race and ethnic origin as well as other characteristics of individuals because these characteristics may influence how people respond to different interventions. Providing information on your race or ethnic origin is voluntary. You do not have to answer any questions that you are not comfortable with. 2. 3-month Assessment The 3-month assessment will take place during the final group meeting during the 12th week. In addition to the repeated survey, we will gather information about your engagement with the program in the active phase and your satisfaction with the program. 3. 6-month Assessment The 6-month assessment will be mailed to your home and you will return it to the Centre for Hip Health and Mobility using a pre-paid and addressed envelope. In addition to the repeated survey we will gather information about your engagement in the program in the taper phase. 4. Interview or Focus Group Below you will be asked to indicate if you are interested and willing to participate in a telephone interview or focus group. A subset (approximately 20) of those who indicate they are willing to be interviewed will be randomly selected and invited to participate in telephone interviews or focus groups with a member of the research team at baseline, 3-months and 6-months. Each interview will take up to 60 minutes or focus group will take up to 90 minutes. We will ask for feedback about the various Choose to Move program components as well as the facilitators and barriers to physical activity participation. The information Page 3 of 8 Version Date: 08-12-2015 gathered from these interviews will be used to better understand the design and implementation of similar interventions and programs in the future. What are the possible harms and side effects of participating? The risks and discomforts associated with this research study are minimal. You do not have to answer any questions that you are not comfortable with. What are the benefits of participating in this research study? No one knows whether or not you will benefit from this research study. There may or may not be direct benefits to you from taking part in this research study. We hope that the new knowledge we obtain from this research can be used in the future to help promote and enable the physical activity and mobility of older adults. What happens if I decide to withdraw my consent to participate? Your participation in this research study is entirely voluntary. You may withdraw from this research study at any time and no reason for withdrawal needs to be provided. If you decide to enter the research study and to withdraw at any time in the future, there will be no penalty or loss of benefits to which you are otherwise entitled, and your future participation in Choose to Move will not be affected. If you choose to enter the research study and then decide to withdraw at a later time, all data collected about you during your enrolment in the study will be retained for analysis unless you request that it be removed also. You do not waive any of your legal rights by signing this consent form. If you wish to withdraw please contact Christa Hoy at 604-675-2581. What happens after the research study is finished? Once your participation in the research study is complete, you may request a summary of your results. You may also request a copy of publications that result from the study. Collected data will be kept indefinitely as results of this study will likely influence the design and execution of future studies. What will the research study cost me? There are no direct costs to participating in this research study. Will my taking part in this research study be kept confidential? Your confidentiality will be respected. However, research records and health or other source records identifying you may be inspected in the presence of the Investigator or his or her designate by representatives of the Centre for Health and Mobility Society, and the UBC and/or SFU Research Ethics Boards for the purpose of monitoring the research. No information or records that disclose your identity will be published without your consent, nor will any information or records that disclose your identity be removed or released without your consent unless required by law. You will be assigned a unique study number as a participant in this study. This number will not include any personal information that could identify you (e.g., it will not include Page 4 of 8 Version Date: 08-12-2015 your Personal Health Number, SIN, or your initials, etc.). Only this number will be used on any research-related information collected about you during the course of this study, so that your identity will be kept confidential. Information that contains your identity will remain only with the Principal Investigator and/or designate. The list that matches your name to the unique study number that is used on your research-related information will not be removed or released without your consent unless required by law. The program coordinator and activity coaches will have access to your name, phone number, and email addresses for the purposes of contacting you to set up appointments. However, no records which identify you by name or initials will be allowed to leave the investigators’ offices. Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. You also have the legal right of access to the information about you that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are available on request to your study principal investigator. Please note that there is a minor limitation to your confidentiality if you participate in a focus group. Given that it is a group situation, members of the group will be identified to one another, thus we cannot guarantee that confidentiality will be maintained. We will advise all participants at the beginning of the session that everything discussed during the focus group should not be discussed outside of the group. Although the objective is to maintain confidentiality, it cannot be guaranteed. The interviews or focus groups will be audio recorded; only researchers on this project will have access to this recording. Any names will be replaced with pseudonyms in transcripts in order to protect your anonymity. By consenting to participate in the research study, you confirm that any information you encounter will be kept confidential and not revealed to parties outside the group. Although the objective is to maintain confidentiality, it cannot be guaranteed. Data will be stored indefinitely. Electronic data will be kept in secure, passwordprotected databases on computers/servers at the Centre for Hip Health and Mobility and hard copy data will stored in a locked filing cabinet in the secure research facilities at the Centre for Hip Health and Mobility. Collection of recorded media (audio, video and photography) As a Choose to Move research study participant, you are being asked for your consent to being photographed, videotaped and/or interviewed. In the future, resulting media (e.g., photographs, video, sound recordings) may be featured in publications and presentations, such as newsletters, articles (in print and online), reports, press releases, presentations at scientific conferences, and training materials. The resulting media may be licensed for commercial gain and without limitation, be reproduced, copied, sold, exhibited, published or distributed. You are also being asked to waive any and all claims that you have or may have in the future against the Centre for Hip Health and Mobility Page 5 of 8 Version Date: 08-12-2015 related to the use of the resulting media and as a result, you will not receive any monetary payment. The optional 60-minute interview or 90-minute focus group will be audio-recorded and transcribed for analysis. Only evaluators for this program will have access to this recording. Data will be securely stored at the Centre for Hip Health and Mobility. The data will be password protected and/or stored in a locked filing cabinet. If you wish to consent to being photographed, videotaped, and/or interviewed, and to the future use of these media for research purposes, please check the appropriate boxes on the Participant Consent form at the end of this document. Who do I contact if I have questions about the research study during my participation? The primary investigator for this study is Dr. Heather McKay. If you have any questions or desire further information about this research before or during participation, you can contact our primary contact Christa Hoy at 604-675-2581. Who do I contact if I have any questions or concerns about my rights as a participant during the study? If you have any concerns about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line, Office of Research Ethics at the University of British Columbia, at 604-822-8598 or toll free at 1-877-822-8598. They can also be contacted by email at [email protected]. You may also contact Dr. Jeffrey Toward, Director, Office of Research Ethics at [email protected] or 778-782-6393. Page 6 of 8 Version Date: 08-12-2015 Active Aging BC: Choose to Move PARTICIPANT CONSENT TO PARTICIPATE I have read and understood the participant information and consent form. I have had sufficient time to consider the information provided and to ask for advice if necessary. I have had the opportunity to ask questions and have had satisfactory responses to my questions. I understand that all of the information collected will be kept confidential and that the result will only be used for the scientific objectives. I understand that my participation in this research study is voluntary and that I am completely free to refuse to participate or to withdraw from this research study at any time. I understand that I am not waiving any of my legal rights as a result of signing this consent form. I understand that there is no guarantee that this study will provide any benefits to me. I have read this form and I freely consent to participate in this study. I have been told that I will receive a dated and signed copy of this form. Future Use Consent: We may use the data collected in this research study for further analysis in future studies interested in enhancing the health and mobility of older adults. For example, we may examine this data in conjunction with an individual follow-up interview. I consent for my data to be used for future studies. Yes No Interview or Focus Group Consent: I consent and would like to be contacted about participating in an interview or focus group (Note: not all participants who consent to participate in the interview or focus group will be contacted) Yes No Consent to be contacted for Future Studies: I would like to be contacted for future studies. Yes No Page 7 of 8 Version Date: 08-12-2015 Active Aging BC: Choose to Move Model Release Consent: As a Choose to Move research study participant, you are being asked for your consent to being photographed, and/or videotaped. In the future, resulting media (e.g., photographs, video, sound recordings) may be featured in publications and presentations, such as newsletters, articles (in print and online), reports, press releases, presentations at scientific conferences, and training materials. The resulting media may be licensed for commercial gain and without limitation, be reproduced, copied, sold, exhibited, published or distributed. You are also being asked to waive all rights you have in connection with the photos and any or all claims that you have or may have in the future against the Centre for Hip Health and Mobility. As a result, you are unable to receive any monetary payment for the photos. 1. Are you willing to be photographed, videoed, audio recorded? Yes No 2. Are you willing to transfer your rights in connection with these media (video, photographs, audio recordings) to the Centre of Hip Health and Mobility? Yes No Signature ______________________________________________________________________ Printed name of participant Signature Date ______________________________________________________________________ Person obtaining consent Study Role Signature Date Page 8 of 8 Version Date: 08-12-2015
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