Common use of Explanation of Procedures Clause in Contracts

Explanation of Procedures. If you agree to take part in this study, you will first sign this consent form. The study staff will then verify you are eligible to take part in the study. You will not be able to take part in this study if you use a BAN as an outpatient at home. Once your eligibility is confirmed you will be randomly assigned “randomized” to receive nebulizer treatments with either SN or BAN. Randomization means you are put into a group by chance. It is like flipping a coin. You have an equal chance (50/50) of being placed in either group. Neither you, the study staff nor your doctor can pick which group you will be assigned. Once you are randomized you will begin to receive your nebulizer treatments only using the device you were assigned to. If you are assigned to SN you will continue to use the SN device (handheld or mask) as you were before enrolling in the study. If you are randomized to BAN, a nurse or respiratory therapist will show you how to use the BAN device. After signing the consent form patients in both groups willbe asked to complete the St. George’s Respiratory Questionnaire for COPD patients. This is a 14-question survey that should take 5-10 minutes to complete. You will also be asked to complete a daily, one question survey rating how you feel about your shortness of breath while you are on nebulizer treatments for up to 7 days. If you are in the BAN group at some point during your hospital stay (likely within 3-4 days) a member of the study staff will ask you to complete a short (less than 5 minutes) survey about how easy or difficult you feel the BAN was to use. Study staff will collect information from your medical record (for up to 6 months after you are discharged from the hospital) like the number of nebulizer treatments you receive, oxygen use, the need for breathing support, how long you stay in the hospital, pulmonary function test results performed after discharge and readmissions to the hospital. A member of the study team may call you after discharge during that 6 months to see how you are doing. They may also contact your primary care doctor or lung doctor. Your care will not be changed or influenced in any way by being in this study. You will receive nebulizer treatments as per your doctor’s orders as frequently and for as long as your doctor feels you need them. There is nothing else you need to do as part of your participation in the study. Some of the services you will receive are being performed only because you are participating in this research study. Examples of these ‘research only’ services include the BAN device (if so randomized) and the surveys. The BAN device is being supplied by the sponsor to Rhode Island Hospital at no cost. The survey will be paid for by the study and will not be billed to you or your health insurance company. Other services you will receive during this research study are considered "routine clinical services" that you would have received even if you were not in the research study. Examples are the nebulizer medication(s), your hospital stay and all other medications, treatments, tests and procedures your doctor orders to treat your condition(s). Nebulizer treatments are billed as a bundle that includes the nebulizer device and the respiratory therapist time to administer the treatment together. Whether you are randomized to BAN or SN the charge for the treatment will be the same. These services will be billed to your health insurance company, but you will be responsible for paying any deductibles, co-payments, or co-insurance that are a normal part of your health insurance plan. If you do not have health insurance, you will be responsible for those costs.

Explanation of Procedures. If you agree to take part in this study, you will first sign this consent form. The study staff will then verify you are eligible be asked to take part attend an orientation and baseline assessment visit at the Weight Control and Diabetes Research Center (WCDRC) in the study. You will not be able to take part in this study if you use a BAN as an outpatient at home. Once your eligibility is confirmed downtown Providence, RI where you will be randomly assigned “randomized” to receive nebulizer treatments with either SN or BAN. Randomization means you are put into a group by chance. It is like flipping a coin. You have an equal chance (50/50) of being placed in either group. Neither you, learn about the study staff nor your doctor can pick which group you will be assigned. Once you are randomized you will begin and have the opportunity to receive your nebulizer treatments only using the device you were assigned toask questions. If you are assigned decide to SN you will continue to use the SN device (handheld or mask) as you were before enrolling in the study. If you are randomized to BANenroll by completing this form, a nurse or respiratory therapist will show you how to use the BAN device. After signing the consent form patients in both groups willbe asked to complete the St. George’s Respiratory Questionnaire for COPD patients. This is a 14-question survey that should take 5-10 minutes to complete. You will also be asked to complete a daily, one question survey rating how you feel about your shortness of breath while you are on nebulizer treatments for up to 7 days. If you are in the BAN group at some point during your hospital stay (likely within 3-4 days) a member of the study staff we will ask you to complete a short variety of questionnaires about your physical activity, eating behaviors, weight history, and demographics. We will also meet with you individually to discuss the requirements for the study and to ensure that the program is a good fit for your needs. If you complete the steps described above you will be scheduled for your initial treatment visit approximately two weeks after your orientation. During this week’s time, we will ask you to wear a motion sensor (less than similar to a wrist-watch) on your dominant wrist for one week. This device will measure level of physical activity as well as the timing, duration, and rate of eating. To be eligible to start treatment, you must have at least 10 hours of wear time on each of 5 minutesweekdays and 1 weekend day. To achieve these goals, we ask that you wear the wrist-watch each day of the week during waking hours and charge the device during the nighttime hours on a charging stand that we will provide. During these two weeks, you will also be scheduled to speak with our study staff over the phone on 4 separate days (two weekdays and two weekend days) survey about how easy or to recount the type and amount of all food and drink consumed over the previous days. These calls will be scheduled at your convenience. If you are able to meet the requirements above, you will begin a 12-session weekly weight loss program at the WCDRC. Sessions will last 30 minutes and will focus on topics such as changing your diet, keeping track of your health behaviors, and coping with difficult emotional and social influences. We will encourage you feel to lose weight at a rate of 1 to 2 pounds per week and to achieve a 7 to 10% weight loss during the BAN was to usecourse of the study. Study staff To do this, we will collect information recommend that you record your food intake and exercise every day. Your weight will be recorded at the WCDRC each week and you will be taught skills for interpreting weight change over time. Additionally, data will be downloaded from your medical record (for up wrist-worn device by a research assistant. We will teach you how to 6 months after limit your dietary intake based on your body’s needs and how to increase your physical activity slowly over the course of the study. After 12 weeks, you will enter the maintenance phase of the study. During this time, you are discharged from expected to continue the hospital) like the number of nebulizer treatments you receive, oxygen use, the need for breathing support, how long you stay weight control practices learned in the hospital, pulmonary function test results performed after discharge and readmissions to the hospital. A member initial 12 weeks of the study team may call you after discharge during that 6 months program to see how you are doing. They may also contact your primary care doctor either maintain or lung doctor. Your care will not be changed or influenced in any way by being in this studycontinue losing weight. You will receive nebulizer treatments as meet with your weight loss councilor once per month at the WCDRC to be weighed, download data from your doctor’s orders as frequently wrist-worn device, and for as long as discuss progress towards your doctor feels you need themgoals. There is nothing else you need to do as part of your participation in the study. Some of the services Additionally, you will receive are being performed only because you are participating in this research studybe scheduled for an appointment at the WCDRC once per month solely for the purposes of obtaining your weight and downloading data from your device. Examples of these ‘research only’ services include the BAN device (if so randomized) and the surveys. The BAN device is being supplied by the sponsor to Rhode Island Hospital at no cost. The survey You will be paid $20 for by attending these visits. At your orientation, we will provide you with detail for how to care for your wrist-worn device. Throughout the study and will not be billed to you or your health insurance company. Other services you will receive during this research study are considered "routine clinical services" that you would have received even if you were not in duration of the research study. Examples are the nebulizer medication(s), your hospital stay and all other medications, treatments, tests and procedures your doctor orders to treat your condition(s). Nebulizer treatments are billed as a bundle that includes the nebulizer device and the respiratory therapist time to administer the treatment together. Whether you are randomized to BAN or SN the charge for the treatment will be the same. These services will be billed to your health insurance company, but you will be responsible for paying any deductiblesasked to wear the wrist-worn sensor every day. Every other week (biweekly), coyou will be asked to complete short surveys about your eating behavior on your personal smartphone. There will be approximately 4 short surveys per day and each one should take approximately 30-payments, or co-insurance that are a normal part of your health insurance plan60 seconds. If you do not have health insurancea smartphone, you will be responsible lent a device for those coststhe duration of the study. At your orientation, we will provide you with more instruction for answering the questions on your smartphone (or study smartphone). During the two weeks between your orientation and initial treatment session, you will be asked to have 4 separate phone calls over a period of 4 days with WCDRC personnel to recount all foods and drinks consumed over the previous 24-hours. This will be repeated at weeks 5, 11, 17, and 23 of the study. We will schedule these calls at your convenience. At your orientation, we explain in more detail how to prepare for these calls. There are no costs for participating in this study. Please call Xxxxxx Xxxxxx, PhD at (000) 000-0000 if you have any questions about these procedures for the study.

Explanation of Procedures. If you agree to take part in this study, you will first sign this consent form. The allow a member of the study staff to go into your medical chart and record a list of the health problems you have (e.g., diabetes, high blood pressure) and the Lifespan - Rhode Island Hospital IRB 1 IRBNet ID: 1102103-22 Approved: August 17, 2021 Expiration: August 16, 2022 Study Volunteer Initials specific diagnosis that caused you to come to CR (e.g., a heart attack). This information will then verify be kept in a confidential chart. If you are eligible choose to take part participate in this study, you will be asked to attend a baseline assessment visit at either the studyWCDRC, CR, over the phone, via mail, or via video conference using Microsoft Teams, GoToMeeting, or Zoom where you will complete questionnaires about your physical activity, eating behaviors, mood, health, and strategies you have used to lose weight as well as a demographic questionnaire. Some of these questionnaires will be on the computer, and some will be a pencil and paper survey. You will complete a very brief assessment of your cognition; this assessment feels like completing a few puzzles and word games. Your height and weight will also be measured or recorded from your CR chart. You will also wear an armband on your upper arm for one week during the majority of your daily activities. This armband will be sized to fit you comfortably. It tracks your physical activity while you are awake. It will not interfere with any devices in your body, particularly devices that affect your heart (e.g., implantable cardioverter defibrillator). All of the information that you provide or that is taken from your medical chart will be kept confidential. Please see Section 9 of this form for additional details on the ways the research staff will maintain your privacy. This first visit will take up to 90 minutes. You will be asked to return to the WCDRC or CR for an assessment visit 3 months into the 6-month treatment program, and again at the end of the 6-month treatment program. Alternatively, you may complete the assessments online via a secure link, by mail, and/or over the phone with one of the research staff members. In that case, you will need to either receive the armband in the mail and send it back to us, or pick it up and drop it off. Again, we will accommodate you based on your preference. At these assessment visits, you will again complete questionnaires and have your weight measured. You will also wear the armband for one week prior to these visits. We will mail the armband to you ahead of time, or you are welcome to meet a member of the research staff to pick it up if that is your preference. You will receive $25 via cash, check or gift card for completing the 3-month visit, and you will receive $50 via cash, check, or gift card for completing the 6-month assessment visit. These two visits will take up to 75 minutes each. Free parking adjacent to the building is available at both sites. All study sites are equipped with automated external defibrillators and CPR-certified staff in the event of an emergency, and CR and the WCDRC are within a 4-minute drive of the The Xxxxxx Hospital and Rhode Island Hospital, respectively. All the participants will receive a 24-week Internet weight loss program. You will be given access to a study website that contains weekly video lessons. These lessons will provide audio and video training for healthy eating and physical activity and will teach you behavioral strategies for implementing these changes. A new video will be posted each week for the first 12 weeks, and you will be able to take part watch these videos whenever you choose. Each video is approximately 15-25 minutes in length. In the second half of the study (months 4-6), you will gain access to one video each month that is specifically tailored to patients like you who have heart disease and are trying to lose weight or maintain weight they have already lost. In addition, you will be asked to enter your daily caloric intake, weight, and exercise minutes onto the study website 12 weeks. After 12 weeks, you will only be asked to enter your weight for that week. Each week, you will receive written online feedback on your progress in the program. The physician that referred you to this study will also be mailed periodic reports over the course of the 24-week weight loss program with information about your progress in the program (e.g., number of video lessons viewed, amount of weight loss). You can be mailed a copy of these reports if you request them. This website is tailored specifically to the needs of CR patients, and it is complementary to your CR program, so you will Lifespan - Rhode Island Hospital IRB 1 IRBNet ID: 1102103-22 Approved: August 17, 2021 Expiration: August 16, 2022 Study Volunteer Initials not receive conflicting advice about what is healthy for you. The website was tailored to meet your needs under the advice of staff from The Xxxxxx Hospital’s CR. If you consent to participate in this study if you use a BAN as an outpatient at home. Once your eligibility is confirmed and complete the baseline assessment visit, you will be randomly assigned “"randomized” to receive nebulizer treatments with either SN or BAN" into one of the study groups described below. Randomization means that you are put into a group by chance. It is like flipping a coin. Which group you are put in is done by a computer. Neither you nor the researcher will choose what group you will be in. You will have an equal chance (50/50) of being placed in either group. Neither youreceiving each additional component, the study staff nor your doctor can pick which group and you will be assignedequally likely to not receive each component. Once you are randomized you Some people in the study will begin not receive any additional components, while some people will receive 1, 2, 3, or all 4. Some participants will receive no additional components beyond the 24-week weight loss program, and by agreeing to receive your nebulizer treatments only using the device you were assigned to. If you are assigned to SN you will continue to use the SN device (handheld or mask) as you were before enrolling be in the study. If , you are willing to use however many components you are randomized to BANreceive. Component 1: Fitbit with a Structured Physical Activity Intervention Half of the participants in this study (80 people) will receive a commercially-available Fitbit, a nurse or respiratory therapist will show you how to use the BAN device. After signing the consent form patients in both groups willbe asked to complete the St. George’s Respiratory Questionnaire for COPD patients. This which is a 14wrist-question survey that should take 5-10 minutes to completeworn physical activity monitor. You These participants will also be asked receive a 10-minute weekly informational video with exercise tips and advice on meeting recommended weekly physical activity minute goals. The research team will encourage participants to complete a dailywalk to meet their physical activity goal due to walking’s safety and accessibility. The research team will monitor these participants’ physical activity through the Fitbit system and will send personalized feedback intended to help participants reach their activity goals. For individuals already achieving the weekly recommended physical activity minute goals, one question survey rating how you feel about your shortness we will provide encouragement and advice for sustaining this frequency and intensity of breath while you are on nebulizer treatments for up physical activity. All participants in this group need to 7 days. If you are in the BAN group at some point during your hospital stay (likely within 3-4 days) a member of the have an email address; study staff can help participants set one up if they do not have an email address or want one that will ask you to complete a short (less than 5 minutes) survey about how easy or difficult you feel be used solely for the BAN was to use. Study staff will collect information from your medical record (for up to 6 months after you are discharged from the hospital) like the number purposes of nebulizer treatments you receive, oxygen use, the need for breathing support, how long you stay in the hospital, pulmonary function test results performed after discharge and readmissions to the hospital. A member of the study team may call you after discharge during that 6 months to see how you are doing. They may also contact your primary care doctor or lung doctor. Your care will not be changed or influenced in any way by being in this study. You will receive nebulizer treatments as per your doctor’s orders as frequently and for as long as your doctor feels you need them. There is nothing else you need to do as part of your participation in the study. Some of the services you will receive are being performed only because you are participating in this research study. Examples of these ‘research only’ services include the BAN device (if so randomized) and the surveys. The BAN device is being supplied by the sponsor to Rhode Island Hospital at no cost. The survey This email address will be paid for by the study linked to a Fitbit account, and this password-protected account will not be billed seamlessly send your data (daily step counts, activity minutes, sleep patterns, and heart rate) to you or your health insurance companyour program. Other services you will receive during this research study are considered "routine clinical services" This means that you would have received even if you were not in the research study. Examples are the nebulizer medication(s), your hospital stay and all other medications, treatments, tests and procedures your doctor orders to treat your condition(s). Nebulizer treatments are billed as a bundle that includes the nebulizer device and the respiratory therapist time to administer the treatment together. Whether you are randomized to BAN or SN the charge for the treatment will be the same. These services will be billed to your health insurance company, but you will be responsible for paying any deductibles, co-payments, or co-insurance that are a normal part of your health insurance plan. If you do not have health insuranceto log into our system to tell us how many steps you took each day. After the study has been completed, you participants who were randomized to this component will keep the Fitbit as their own personal device and data will no longer be responsible for those costsextracted from the Fitbit.

Explanation of Procedures. If you agree to take part in this study, you will first sign this consent form. The allow a member of the study staff to go into your medical chart and record a list of the health problems you have (e.g., diabetes, high blood pressure) and the specific diagnosis that caused you to come to CR (e.g., a heart attack). This information will then verify be kept in a confidential chart. If you are eligible choose to take part participate in this study, you will be asked to attend a baseline assessment visit at either the studyWCDRC or CR where you will complete questionnaires about your physical activity, eating behaviors, mood, health, and strategies you have used to lose weight as well as a demographic questionnaire. Some of these questionnaires will be on the computer, and some will be a pencil and paper survey. You will complete a very brief assessment of your cognition; this assessment feels like completing a few puzzles and word games. Your height and weight will also be measured. You will also wear an armband on your upper arm for one week during the majority of your daily activities. This armband will be sized to fit you comfortably. It tracks your physical activity while you are awake. It will not interfere with any devices in your body, particularly devices that affect your heart (e.g., implantable cardioverter defibrillator). All of the information that you provide or that is taken from your medical chart will be kept confidential. Please see Section 9 of this form for additional details on the ways the research staff will maintain your privacy. This first visit will take up to 90 minutes. You will be asked to return to the WCDRC or CR for an assessment visit 3 months into the 6-month treatment program, and again at the end of the 6-month treatment program. Alternatively, you may complete the assessments online via a secure link. In that case, you will need to either receive the armband in the mail and send it back to us, or pick it up and drop it off. Again, we will accommodate you based on your preference. At these assessment visits, you will again complete questionnaires and have your weight measured. You will also wear the armband for one week prior to these visits. We will mail the armband to you ahead of time, or you are welcome to meet a member of the research staff to pick it up if that is your preference. You will receive $25 for completing the 3-month visit, and you will receive $50 for completing the 6-month assessment visit. These two visits will take up to 75 minutes each. Free parking adjacent to the building is available at both sites. All study sites are equipped with automated external defibrillators and CPR-certified staff in the event of an emergency, and CR and the WCDRC are within a 4-minute drive of the The Xxxxxx Hospital and Rhode Island Hospital, respectively. The Newport Hospital’s CR program is located on the Newport Hospital’s campus. All the participants will receive a 24-week Internet weight loss program. You will be given access to a study website that contains weekly video lessons. These lessons will provide audio and video training for healthy eating and physical activity and will teach you behavioral strategies for implementing these changes. A new video will be posted each week for the first 12 weeks, and you will be able to take part watch these videos whenever you choose. Each video is approximately 15-25 minutes in length. In the second half of the study (months 4-6), you will gain access to one video each month that is specifically tailored to patients like you who have heart disease and are trying to lose weight or maintain weight they have already lost. In addition, you will be asked to enter your daily caloric intake, weight, and exercise minutes onto the study website 12 weeks. After 12 weeks, you will only be asked to enter your weight for that week. Each week, you will receive written online feedback on your progress in the program. The physician that referred you to this study will also be mailed periodic reports over the course of the 24-week weight loss program with information about your progress in the program (e.g., number of video lessons viewed, amount of weight loss). You can be mailed a copy of these reports if you request them. This website is tailored specifically to the needs of CR patients, and it is complementary to your CR program, so you will not receive conflicting advice about what is healthy for you. The website was tailored to meet your needs under the advice of staff from The Xxxxxx Hospital’s CR. If you consent to participate in this study if you use a BAN as an outpatient at home. Once your eligibility is confirmed and complete the baseline assessment visit, you will be randomly assigned “"randomized” to receive nebulizer treatments with either SN or BAN" into one of the study groups described below. Randomization means that you are put into a group by chance. It is like flipping a coin. Which group you are put in is done by a computer. Neither you nor the researcher will choose what group you will be in. You will have an equal chance (50/50) of being placed in either group. Neither youreceiving each additional component, the study staff nor your doctor can pick which group and you will be assignedequally likely to not receive each component. Once you are randomized you Some people in the study will begin not receive any additional components, while some people will receive 1, 2, 3, or all 4. Some participants will receive no additional components beyond the 24-week weight loss program, and by agreeing to receive your nebulizer treatments only using the device you were assigned to. If you are assigned to SN you will continue to use the SN device (handheld or mask) as you were before enrolling be in the study. If , you are willing to use however many components you are randomized to BANreceive. Component 1: Fitbit with a Structured Physical Activity Intervention Half of the participants in this study (80 people) will receive a commercially-available Fitbit, which is a nurse wrist-worn physical activity monitor. These participants will also receive a 10-minute weekly informational video with exercise tips and advice on meeting recommended weekly physical activity minute goals. The research team will encourage participants to walk to meet their physical activity goal due to walking’s safety and accessibility. The research team will monitor these participants’ physical activity through the Fitbit system and will send personalized feedback intended to help participants reach their activity goals. For individuals already achieving the weekly recommended physical activity minute goals, we will provide encouragement and advice for sustaining this frequency and intensity of physical activity. All participants in this group need to have an email address; study staff can help participants set one up if they do not have an email address or respiratory therapist want one that will show you how to use be used solely for the BAN device. After signing the consent form patients in both groups willbe asked to complete the St. George’s Respiratory Questionnaire for COPD patientspurposes of this study. This is email address will be linked to a 14Fitbit account, and this password-question survey protected account will seamlessly send your data (daily step counts, activity minutes, sleep patterns, and heart rate) to our program. This means that should take 5-10 minutes you do not have to completelog into our system to tell us how many steps you took each day. You will also be asked to complete a daily, one question survey rating how you feel about your shortness of breath while you are on nebulizer treatments Component 2: Bite Counter Device for up to 7 days. If you are in the BAN group at some point during your hospital stay (likely within 3-4 days) a member Dietary Restriction Half of the participants in this study staff (80 people) will ask you to complete receive a short (less than 5 minutes) survey about how easy or difficult you feel the BAN was to use. Study staff will collect information from your medical record (for up to 6 months after you are discharged from the hospital) like commercially-available wrist-worn device that counts the number of nebulizer treatments you receive, oxygen use, the need for breathing support, how long you stay in the hospital, pulmonary function test results performed after discharge and readmissions times that food is brought to the hospitalmouth during an eating episode. A member Participants in this group will be instructed to wear the Bite Counter on their dominant wrist during waking hours and press a button on the watch when they start and stop eating. After two weeks of using the Bite Counter in this fashion, we will provide a bite goal for each meal. The bite goal is a number of bites to take per meal that should allow you to eat enough food without going off the reduced-calorie diet that we recommend; the bite goal is tailored to you based on how you tend to eat. When you reach the bite goal, a small alarm will sound from the watch notifying you to stop eating; the Bite Counter tracks the number of bites for you. The device can be customized with different bands of different styles and sizes to meet your needs and to maximize comfort. We will ask participants in this condition to briefly visit our office two weeks into the study, then another 2 weeks later, and then monthly so we can download the data (the number of bites you took each day). This visit will be 5 minutes long and scheduled at your convenience. At this visit, we will wipe your old data off your device and help you if you are running into trouble with the Bite Counter. Alternatively, after the first visit we can help participants send us the data using a secure server that does not record your personal information. Component 3: Virtual Reality for Behavioral Weight Loss Skills Practice Half of the study team may call you after discharge during that 6 months to see how you are doing. They may also contact your primary care doctor or lung doctor. Your care will not be changed or influenced in any way by being participants in this study. You study (80 people) will receive nebulizer treatments as per your doctor’s orders as frequently exclusive access to an online program that allows participants to practice using behavioral weight loss skills in a virtual reality setting. All participants must have a home personal computer or laptop to complete this program. The program provides 4 interactive scenarios (1 every 2 weeks), and each scenario (once released) is available for as long as your doctor feels you need them. There is nothing else you need to do as part the duration of your participation in the study. Some The purpose of each scenario is to allow you to assume the role of the services you will receive character, Xxxx, who is navigating her home, work, social, and gym environments as she tries to make healthy choices in service of weight loss. There are being performed only because you are participating in this research study. Examples of these ‘research only’ services include the BAN device (if so randomized) and the surveys. The BAN device is being supplied by the sponsor to Rhode Island Hospital at no cost. The survey will be paid for by the study and will not be billed to you right or your health insurance company. Other services you will receive during this research study are considered "routine clinical services" that you would have received even if you were not in the research study. Examples are the nebulizer medication(s), your hospital stay and all other medications, treatments, tests and procedures your doctor orders to treat your condition(s). Nebulizer treatments are billed as a bundle that includes the nebulizer device and the respiratory therapist time to administer the treatment together. Whether you are randomized to BAN or SN the charge for the treatment will be the same. These services will be billed to your health insurance companywrong answers, but you will be responsible for paying any deductibles, coallowed to choose Xxxx’s actions and see the consequences. The purpose of the program is to allow you to practice the skills that will help you successfully lose weight in a non-payments, or co-insurance that are a normal part judgmental setting from the comfort of your health insurance plan. If you do not have health insurance, you will be responsible for those costsown home.