PARTICIPANT INFORMATION SHEET

Transcription

1 PARTICIPANT INFORMATION SHEET Protocol title: Investigation into the Development and Validation of Cardiorespiratory Fitness, Metabolic Rate and Activity Algorithms for Wearable Devices Protocol number: HQ_VO2MAX001 Name of principal investigator: Dr Koch Visser Introduction You are invited to participate in a research study that focuses on developing cardiorespiratory fitness, activity and metabolic rate monitoring solutions using a wearable device. Before you agree to take part in this research study, you must please read this information sheet as it contains important information to help you decide whether it is in your best interests to do so or not. You are encouraged to ask as many questions as needed to ensure that you understand the study procedures, including possible risks and benefits. If you have any questions that are not properly explained or answered in this information sheet, please feel free to ask the testing administrator to give you more information. The study has been approved by the Pharma-Ethics Research Ethics Committee for compliance with ethical standards. In addition to this, the study will be conducted according to the 2013 Declaration of Helsinki and Guidelines for good practice in the conduct of clinical trials with a human participant in South Africa, second edition, 2006, which deals with your rights as a research participant and which guide the study investigator in biomedical research involving human participants. Your rights as a participant Your participation in this study is voluntary. You may choose not to be in the study or to leave the study at any time by telling the testing administrator. If you decide not to participate in the study or to withdraw your consent, you will not lose any benefits to which you are otherwise entitled. The testing administrator has the right to withdraw you from the study if it is in your best interests and the reasons for this will be given to you. If the research investigator finds you did not provide the correct personal details or did not follow the guidelines in this document and the study protocol, you may be withdrawn from the study at any time. Purpose of the study The purpose of this study is to develop and validate LifeQ s fitness, activity and metabolic metric estimations using data collected from wearable devices. These metrics include VO2max, VO2min, Energy Expenditure, EPOC and Steps. These metrics will be measured using the gold standard COSMED device as well as the FitBitOne device and predicted using the LifeQ-enabled wearable device. The COSMED device measures the amount of oxygen you consume and the amount of carbon dioxide you breath out. Version 1.0 Page 1 of 6

2 It requires a facial gas mask or a hood attached to a computer to monitor these measurements. The FitbitOne is a hip-worn step counter. The results of this study will allow HealthQ to develop solutions that will make the monitoring of VO2max, VO2min, EE, EPOC and steps affordable, easy to use and available to the general population. Study design and procedure This is a non-invasive 23-day long study. The protocol will require you to visit the test site on two different occasions for approximately 2 hours at a time. You will also be required to take part in 3 weeks of free-living data collection in which you will go about your daily routine while wearing a LifeQ-enabled wearable device(s). If you agree to take part you will perform the protocol shown in Figure 1 below. Figure 1: Timeline of the study, including the 2 different site visits and free-living data collection period. RMR= resting metabolic rate test. After receiving your informed consent, you will be sent a questionnaire which includes questions about your personal information (age, gender, height etc.), access to a computer and the internet, lifestyle and medical history. This information is used to determine whether you are eligible for the study or not. The questionnaire should take approximately 10 minutes to fill in. Once you have been selected for the study, the testing administrator will confirm an appointment for your first and second test site visit at a convenient time to you. Site visit 1 During the first site visit, your height, weight, waist circumference, hip circumference and body fat percentage will be measured. A heart rate monitor will be placed around your chest and a step counter placed just above your hip. In addition, LifeQ-enabled wearable device(s) will be placed on your wrist. You will be briefed on how to use the wearable device and an account will be created for you with the LifeQ software. Once all devices have been fitted, you will lie on your back on a bed. A canopy hood or dome will be placed around your head and fitted just over your shoulders. Once the equipment is attached you will need to lie on the bed without speaking or falling asleep for 20 minutes. This test measures your resting metabolic rate by measuring the gases that you inhale and exhale at rest. Following this, the canopy hood will be removed and you will be asked to get onto the treadmill. You will be asked by the testing administrator to run on the treadmill at a comfortable pace at differing speeds. Up to 5 submaximal Version 1.0 Page 2 of 6

3 exercise tests may need to be performed depending on how your heart rate stabilizes. Once this test has been completed, you will sit with the testing administrator for 15 minutes while they show you how to use the LifeQ software, how to charge the device and how to download data from the device. You will be asked to wear the device continuously for a period of 3 weeks following this. You will need to ensure that the device is charged when the battery runs low and that the data is uploaded when the storage becomes full (± every 2 days). Site visit 2 After approximately 3 weeks, you will come in for a second site visit. During the site visit you will have your weight, waist circumference, hip circumference and body fat percentage measured again. You will once again be fitted with a heart rate monitor around your chest, a step counter just above your hip and the LifeQ-enabled wearable device(s). You will then be asked to assume a range of postures (lying, sitting, standing) so that we can see how your body responds to these actions. After this a safety harness will be strapped around your chest. You will also be fitted with a facial gas mask around your mouth and nose. The testing administrator will start the treadmill at a slow walking speed and will increase the speed at progressive intervals. You will be asked to continue running until maximal exhaustion to get the most accurate measurement of your maximal oxygen consumption. After you have stopped, you will sit down for a recovery period lasting 25 minutes, during which all the devices will be kept on. At the end of this period all devices will be removed. You will also need to keep to your normal dietary habits and exercise routine for the duration of the study and your test results from the VO2max test will be sent to you once you have completed the study. For this study to be successful, it is important that you co-operate fully with the testing administrator and follow his or her instructions precisely. You will be given instructions for reference when you are briefed on how to use the LifeQ-enabled wearable device and support will be available should you have any questions. If you forget anything or deviate from the protocol in anyway, please inform us. What are the possible risks of being in the study? The probability and magnitude of harm or discomfort anticipated in the study is perhaps slightly greater than that ordinarily encountered in daily life due to the nature of the VO2max test. The potential risks to you associated with the VO2max test, as with any intense physical exertion, are: abnormal blood pressure, fainting, irregular, fast or slow heart rhythm, muscle cramps and delayed onset muscle soreness (1 to 2 day afterwards). Additional risks may include accidental injury due to tripping and falling. Given that the nature of data collection is non-invasive and only participants that meet safety criteria for exercise testing (screened with the questionnaire) are included in the study this study poses minimal risk to you. You may find the devices are somewhat uncomfortable to wear and it is possible that you may find the facial mask ad canopy hood or dome uncomfortable to wear, especially if you experience claustrophobia. If this is the case, please let the testing administrator know right away. The COSMED device is an FDA approved device and has therefore been cleared for use in a research environment. The LifeQ-enabled wearable device(s) used in this study include commercially available Version 1.0 Page 3 of 6

4 wearables and research devices that have been through a quality control assessment at HealthQ Technologies. There are no known risks associated with wearing these devices What are the possible benefits of being in the study? The direct benefit that you will receive for taking part in the study is the opportunity to learn something more about your cardiorespiratory fitness. HealthQ Technologies will provide you with a report which will include the results of your VO2max test and a comparison of your results to a normative population. The COSMED device is a very expensive piece of equipment (R ) and requires a trained operator for use. Therefore, we expect that the LifeQ algorithms that have been developed will provide an affordable and easy way to monitor fitness, activity and metabolic parameters and that this will benefit society and the community by making these solutions accessible both in the clinical and home setting. Compensation in the event of study related injury The research study is covered by an insurance policy taken out by HealthQ Technologies in the event that you suffer bodily injury as a result of taking part in the VO2max test or other tests you take part in during your site visit at the HealthQ Technologies Offices. If you are harmed and the insurer pays for the necessary medical costs, usually you will be asked to accept that insurance payment as full settlement of the claim for medical costs. However, accepting this offer of insurance cover does not mean you give up your right to make a separate claim for other losses based on negligence, in a South African court. Confidentiality All participants will be assigned a Test Participant Identifier (TPID) number, which will be associated with your personal information (name, surname and date of birth), measurements and questionnaire data. All TPIDs and associated information will be stored in a locked Google Sheets file. Individuals accessing the measurements or questionnaire data will only be able to access the TPID number and not your name. Participants will also be issued with a Source ID when registering with the LifeQ software. This ID will be associated with the data that you upload with the LifeQ enabled wearable device(s). The Source ID will be linked to the TPID in the locked google sheet. HealthQ analysts will only have access to the Source ID and therefore no personal information. You have the right to control the use and disclosure of your personal information. Basic personal information will be recorded including your name, contact details, gender, height, weight, etc., as well as information collected in the questionnaire, and physiological data collected during your participation in the study. The following people may also access these records: The principal investigator and testing administrators working for HealthQ Technologies, who check that the study is being performed correctly and that the information collected about you is accurate; Version 1.0 Page 4 of 6

5 The Research Ethics Committees that approved this study and ensures that your rights and wellbeing are safeguarded; National and international regulatory authorities involved in keeping research safe for participants. All personnel accessing your records are required to respect your confidentiality at all times. Representatives from government agencies such as the National Health Research Ethics Council (NHREC) as well as Pharma-Ethics Research Ethics Committee and HealthQ Technologies may need access to your study records to confirm that the study data collected about you is correct and relates to you. The de-identified data will be analysed to determine whether wearable devices can indeed predict fitness, metabolic and activity measures accurately. Researchers who study the information will not know who you are as the information they get will only have the code number and not your name. Your de-identified data may also be used by HealthQ Technologies, its affiliates and its partners for future analyses and development. You will remain anonymous in any publication resulting from this study. Under data protection law Protection of Personal Information Act 2013 HealthQ Technologies will be responsible as controllers to ensure that your information is safeguarded. Your data might be transferred to a country that may not have the same level or personal data protection as South Africa. If your data is transferred outside South Africa, HealthQ Technologies is responsible for protecting your data. You have the right to ask the testing administrator about the data being collected on you and to see your personal health information. If you should withdraw from the study, data collected prior to your withdrawal may still be processed along with other data collected as part of the study. This prior information will remain accessible to you, HealthQ Technologies, its affiliates and its partners, but any data collected from that point onwards will no longer be accessible to HealthQ Technologies, its affiliates and its partners. You may withdraw from the study at any time. Payment, expenses and costs You will not receive payment for participating in this study. Any study-related costs, such as procedures specified in the protocol will be paid for by HealthQ Technologies. HealthQ Technologies has made provision to reimburse you for out-of-pocket expenses such as travelling to and from the study site, as well as for your time. You will receive a R40.00 per site visit for your time and R100 to reimburse you for petrol expenses (total of R180.00). If participants are expected to spend additional time at the site because of longer procedures needing to be performed, they will be further reimbursed for their time. Termination of participation Your participation in the study may be stopped for the following reasons: If you don t follow the testing administrator s instructions. If you do not follow the study procedure as prescribed. Version 1.0 Page 5 of 6

6 If the testing administrator decides that it is in your best interests. If there aren t enough participants in the study, or the study has acquired the required number of participants. If HealthQ Technologies stops the study or closes the study site for unknown reasons. Study results You will be ed your study results. When the algorithms that are developed and validated using your data are released as a product, the white paper detailing their validation will be published online. Version 1.0 Page 6 of 6