RESEARCH PARTICIPANT CONSENT AND PRIVACY AUTHORIZATION FORM
Study Title: Home-based Health Management of COPD Patients
Principal Investigator: Roberto Benzo and Colleagues
Please read this information carefully. It tells you important things about this research study. A member of our research team will talk to you about taking part in this research study. If you have questions at any time, please ask us.
Take your time to decide. Feel free to discuss the study with your family, friends, and healthcare provider before you make your decision.
To help you decide if you want to take part in this study, you should know:
- Taking part in this study is completely voluntary.
- You can choose not to participate.
- You are free to change your mind at any time if you choose to participate.
- Your decision won’t cause any penalties or loss of benefits to which you’re otherwise entitled.
- Your decision won’t change the access to medical care you get at Mayo Clinic now or in the future if you choose not to participate or discontinue your participation.
For purposes of this form, Mayo Clinic refers to Mayo Clinic in Arizona, Florida and Rochester, Minnesota; Mayo Clinic Health System; and all owned and affiliated clinics, hospitals, and entities.
If you decide to take part in this research study, you will sign this consent form to show that you want to take part. We will give you a copy of this form to keep.
If you are signing this consent form for someone else, “you” in the consent form refers to the participant.
If you have questions about study tests and procedures, research-related injuries or emergencies, any research-related concerns or complaints, withdrawing from the research study, materials you receive, or research-related appointments; then please contact Dr. Roberto Benzo or Johanna Hoult at (877) 747-4442 or write to 200 First Street SW, Rochester, MN 55905.
If you have questions about rights of a research participant, then contact the Mayo Clinic Institutional Review Board (IRB) at (866) 273-4681.
If you have questions about rights of a research participant, any research-related concerns or complaints, use of your protected health information, or stopping your authorization to use your protected health information, then contact the Research Subject Advocate, who is independent of the research team, at (866) 273-4681 or send email to firstname.lastname@example.org.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Website will not include information that can identify you. At most, the Website will include a summary of the results. You can search this Website at any time.
A description of this research study will be available on http://www.mayo.edu/research/clinical- trials. This website will not include information that can identify you. You can search this website at any time.
1. Why are you being asked to take part in this research study?
You are being asked to take part in this research study because you have medical diagnoses of Chronic Obstructive Pulmonary Disease.
The plan is to have about 115 people take part in this study at Mayo Clinic.
2. Why is this research study being done?
Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.
3. Information you should know
Who is Funding the Study?
The National Heart, Lung and Blood Institute (NHLB) is funding the study. The NHLB will pay your study doctor or the institution to cover costs related to running the study.
Information Regarding Conflict of Interest:
Your doctor may be referring you to this study and if your doctor is also an Investigator in this study, he or she has a conflict by having two sets of interests (your well-being, and the scientific conduct of the study). If you are uncomfortable with your doctor working with you as part of this research study, but still wish to participate in the research, you may request to work with a different member of the research team.
4. How long will you be in this research study?
You will be in this study for about 7 months.
5. What will happen to you while you are in this research study?
You will be asked to use a System Home Rehabilitation Monitoring for completing a Home Pulmonary Rehabilitation Program. The System consists of two small activity monitors worn on your ankle and wrist and a pulse oximeter worn on your finger while you do exercises at home. You will be given simple exercises to complete daily. The monitors you wear will send information to you rehabilitation coach through a small computer tablet. The small tablet will ask you four brief questions regarding your health every day. During enrollment you will be given instructions on how to use the System and will be allowed ample time to become comfortable with it. You will be also asked to wear the small ankle activity monitor throughout the day to track your regular activity.
If you are willing to participate and eligible for the study, we will assign you by chance (like a coin toss) to one of two groups. Group A will complete the study activities during the first 8 weeks of participation, followed by 8 weeks of observation. Group B will complete 8 weeks study activities after 8 weeks of observation. You will have an equal chance of being assigned to the each group. Your assignment to a certain group is totally random but you will receive the intervention no matter in which group you are: neither you nor the investigators can choose your study group.
You will also be asked to participate in 7 telephone-based health coaching calls over an 8-week period. You may also be asked to complete a brief telephone interview to share your experience with the monitor and health coaching. All telephone calls will be audio taped for the purpose of evaluating the health coaching program. The audio tapes will be destroyed after the program evaluation has taken place.
During enrollment, weeks 9 and 17 of the study, we will also measure your physical activity by using an armband monitor and learn about your breathing and general view of health and activity by asking you to complete short questionnaires.
All study materials will be mailed to you and materials will be provided for return of devices and study measures to the clinic. After enrollment, you are not required to come to the Mayo Clinic to participate in this study.
Questionnaires: You will be asked to complete several questionnaires at enrollment, weeks 9 and 17 of the study. Weeks 9 and 17 will be mailed to you to complete and return via a postage-paid envelope. It should take about 20 minutes to complete the questionnaires.
Armband Activity Monitor: A small activity monitor will be worn on your arm for 5 days following your visit today and again at enrollment, week 9 and week 17. The monitor will be mailed to you and you will return them in a provided postage-paid envelope.
Health Coaching: During the Activity period of your participation, you will receive weekly telephone calls by a health coach for 8 weeks to discuss your activity goals and experiences with the Home Rehabilitation Monitoring System. The calls should take no longer than 20 minutes.
Home Rehabilitation Monitoring System: You will be provided a very simple exercise routine along with a Home Rehabilitation Monitoring System to be used at least 6 days per week for 8 weeks during the health coaching program.
6. What are the possible risks or discomforts from being in this research study?
Many physical side effects, such as sore muscles, go away shortly after the exercise is stopped, but in some cases side effects can be serious, long lasting, or may never go away.
Home Rehabilitation Monitoring System:
There is no known risk to using the Home Rehabilitation Monitoring System.
Activity Monitoring Armband:
Wearing the activity monitor armband may rarely (less than 1%) cause skin irritation or redness. To prevent irritation, you will be instructed to remove the armband for 1 hour each day.
Some questions you will be asked to answer in the study questionnaire(s) may make you feel uncomfortable. You may choose not to answer any questions that make you feel uncomfortable.
The risks of this research study are minimal, which means that we do not believe that they will be any different than what you would experience at a routine clinical visit or during your daily life.
7. Are there reasons you might leave this research study early?
You may decide to stop at any time. You should tell the Principal Investigator if you decide to stop and you will be advised whether any additional tests may need to be done for your safety.
In addition, the Principal Investigator or Mayo Clinic may stop you from taking part in this study at any time:
o if it is in your best interest,
o if you don’t follow the study procedures, or
o if the study is stopped.
If you leave this research study early, or are withdrawn from the study, no more information about you will be collected; however, information already collected about you in the study may continue to be used.
8. What if you are injured from your participation in this research study?
Where to get help:
If you think you have suffered a research-related injury, you should promptly notify the Principal Investigator listed in the Contact Information at the beginning of this form. Mayo Clinic will offer care for research-related injuries, including first aid, emergency treatment and follow-up care as needed.
Who will pay for the treatment of research related injuries:
Care for such research-related injuries will be billed in the ordinary manner, to you or your insurance. You will be responsible for all treatment costs not covered by your insurance, including deductibles, co-payments and coinsurance.
9. What are the possible benefits from being in this research study?
This study may not make your health better. However, by participating in this study we believe that you may improve the management of your health.
10. What alternative do you have if you choose not to participate in this research study?
You do not have to be in this study to receive treatment for your condition. Your other choices may include pulmonary rehabilitation. You should talk to the researcher and your regular physician about your choices before you decide if you will take part in this study.
11. What tests or procedures will you need to pay for if you take part in this research study?
You won’t need to pay for tests and procedures which are done just for this research study. These tests and procedures are:
- Home-based Pulmonary Rehabilitation
- Use of Monitoring System
- Health Coaching
However, you and/or your insurance will need to pay for all other tests and procedures that you would have as part of your clinical care, including co-payments and deductibles.
12. Will you be paid for taking part in this research study?
We will pay you $200 if you complete the study. If you don’t complete the study, we will pay you $25 each time you complete the questionnaires and wear the activity monitoring armband.
13. How will your privacy and confidentiality of your records be protected?
Mayo Clinic is committed to protecting the confidentiality of information obtained about you in connection with this research study.
All study subjects will be assigned unique study identifiers that will appear on all data collection instruments, tapes, documents, and files used in the statistical analysis and manuscript preparation. Personal information needed for tracking and informed consent will be stored separately from other data with only limited team members having access to that data.
During this research, information about your health will be collected. Under Federal law called the Privacy Rule, health information is private. However, there are exceptions to this rule, and you should know who may be able to see, use and share your health information for research and why they may need to do so. Information about you and your health cannot be used in this research study without your written permission. If you sign this form, it will provide that permission.
Health information may be collected about you from:
· Past, present and future medical records.
· Research procedures, including research office visits, tests, interviews and questionnaires.
Why will this information be used and/or given to others?
· To do the research.
· To report the results.
· To see if the research was done correctly.
If the results of this study are made public, information that identifies you will not be used.
Who may use or share your health information?
· Mayo Clinic research staff involved in this study.
With whom may your health information be shared?
· The Mayo Clinic Institutional Review Board that oversees the research.
· Other Mayo Clinic physicians involved in your clinical care.
· Federal and State agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health and other United States agencies) or government agencies in other countries that oversee or review research.
· The sponsor(s) of this study and the people or groups it hires to help perform this research.
· A group that oversees the data (study information) and safety of this research.
Is your health information protected after it has been shared with others?
Mayo Clinic asks anyone who receives your health information from us to protect your privacy; however, once your information is shared outside Mayo Clinic, we cannot promise that it will remain private and it may no longer be protected by the Privacy Rule.
Your Privacy Rights
You do not have to sign this form, but if you do not, you cannot take part in this research study. If you cancel your permission to use or share your health information, your participation in this study will end and no more information about you will be collected; however, information already collected about you in the study may continue to be used. If you choose not to take part or if you withdraw from this study, it will not harm your relationship with your own doctors or with Mayo Clinic.You can cancel your permission to use or share your health information at any time by sending a letter to the address below:Mayo ClinicOffice for Human Research ProtectionATTN: Notice of Revocation of Authorization 200 1st Street SWRochester, MN 55905Alternatively, you may cancel your permission by emailing the Mayo Clinic Research Subject Advocate at: email@example.comPlease be sure to include in your letter or email:
· The name of the Principal Investigator,
· The study IRB number and /or study name, and
· Your contact information.
Your permission lasts until the end of this study, unless you cancel it. Because research is an ongoing process, we cannot give you an exact date when the study will end.