We’re looking to create the next generation of digital therapies for MSK pain, and we’d like you to get involved.

Please email help@hingehealth.com or call (855) 902-2777 if you would like to opt out of research after finishing your program application.

Download This Document Here

Participant Information Leaflet & Consent Form

TITLE: Efficacy and Effectiveness of a Digital Clinic

PROTOCOL NO.: WCG IRB Protocol #20204196

SPONSOR: Hinge Health, Inc. (Hinge Health)

INVESTIGATOR:

Mindy Hong, PhD

455 Market St Suite 700

San Francisco, CA 94105

United States

STUDY-RELATED PHONE NUMBER(S): (855) 902-2777 (24 hours)

Introduction

Chronic pain is a leading cause of pain and disability worldwide. The causes of acute and chronic pain vary but are generally caused by tissue sprains or strains, age, or injury. Often there is no single cause identifiable, but the pain is real nonetheless. Even in cases of non-specific pain, self-management techniques may provide a powerful way to manage and reduce pain. 

Hinge Health wants to advance the delivery of care for chronic and acute musculoskeletal pain. To do so, Hinge Health’s Digital Clinic includes several programs: a Wellness Program, an Acute Program, a Chronic Program, an Expert Medical Opinion Program, a Surgical Program, a Women’s Pelvic Health Program, and a Fall Prevention Program. Depending on the program, participants may: 

• receive educational articles

• meet virtually with a physical therapist 

• get support from a health coach

• use biometric sensors or computer vision that interact with the Digital Clinic app for use during exercise therapy

• receive an Enso device

• meet virtually with an expert physician for medical opinions about elective musculoskeletal procedures. 

We believe that technology has the potential to improve the delivery of this care for patients. So, we are inviting you to participate in research studies to help us determine how digital care can best help people with chronic and acute musculoskeletal (MSK) pain using the Digital Clinic.

In particular, we are asking you to decide if you are willing to give your broad consent now to use your identifiable personal information (meaning information that identifies your name or otherwise can be linked to you) in different types of research studies in the future, as further described in this form. If you give your broad consent, researchers may use your identifiable personal information in different research studies in the future, without asking your permission again for any specific research study. 

Please ask us about anything in this form that you do not understand, and only make a decision if you have had all your questions answered and have had enough time and opportunity to consider whether to agree to give this broad consent. 

Disclosure:  The investigator for these research studies, Dr. Mindy Hong, has received equity (shares of ownership) in the Sponsor, Hinge Health. Also, other individuals who work on the studies may be employed or paid by, or have equity in, Hinge Health. Please feel free to ask any further questions you might have about this matter.

What kind of studies might you conduct?

We believe research is important for helping us improve care recommended for chronic and acute MSK pain and its delivery. Our hope is that the studies will help us evaluate and enhance the effectiveness of Hinge Health’s programs for improving outcomes. We expect at least 425 participants will be in this research.

Possible research studies include:

Correlation studies. These studies look for relationships between patient factors and outcomes and will be done for participants in the Wellness, Acute, Chronic, Expert Medical Opinion, Surgical, Women’s Pelvic Health, and Fall Prevention programs. For example, we may examine the correlation between participating in Hinge Health or not and pain reduction over time. Or, we may study how engaged older adults are in comparison to younger adults.

Experimental studies. These studies introduce an intervention and assess the effects. These experimental studies are randomized, meaning the members are grouped by chance (as if by tossing a coin) and there is a 1 in 2 chance to be in either group. 

For example, we may randomize one group to receive a new message about exercises, and another group will receive the usual message. We will examine whether the new message changes the number of exercise sessions in each group.

Who will conduct the studies?

Hinge Health will conduct the studies and may collaborate with researchers in universities or research consultants. Hinge Health clinical researchers are all trained in the requirements of conducting research with human subjects, and collaborators will be required to meet these standards as well.

What data may be used in studies?

As part of the studies, we will collect and store information about you over time. We may ask you questions about you (e.g., age, gender), clinical outcomes (e.g., pain, function, mood, wellness), health care services use, and opinions about chronic and acute MSK pain and Hinge Health. We may gather information through your use of the Digital Clinic, including the Hinge Health app, sensors, or computer vision. We may also combine your data with information from other sources, such as health records or medical claims data.

Will my data be kept confidential?

Data and records related to your participation in studies will be held confidential except when sharing the information is required by law or as described in this informed consent.  Hinge Health or persons working on behalf of, or affiliated with, Hinge Health, and under certain circumstances, the United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB) overseeing the study will be able to inspect and copy confidential study-related data and records which identify you by name.  These data and records may also be shared with regulatory bodies such as FDA and other U.S. and non-U.S. regulatory bodies to support further research, approval, and marketing.  This means that absolute confidentiality cannot be guaranteed.

Any public presentations of data, such as posters, white papers, and peer-reviewed publications, will only use de-identified data, meaning your identity will not be disclosed.  Information may also be shared with the entity which pays for your participation in Hinge Heath programs, but in an aggregated and de-identified format.

What are the possible benefits or risks of taking part in studies?

The benefit of research is that it may help in advancing care through improvement of the Digital Clinic and associated approaches to care. You may not receive any direct benefit to health from participating in the study. 

Participation in the Digital Clinic will include all the standard risks associated with exercise and education programs. In addition, any tests involving modifications of existing programs may result in reduced efficacy, or increased risks of injury than what is normally associated with the program. For example, exercise therapy programs generally include risks of some temporary pain or discomfort, and these risks may increase based on product modifications. In addition, as part of participating in the study and authorizing the use or protected health information and other confidential information, there may be an increased risk of losing confidentiality to your personal information. 

Another risk is that your personal information could be used in a research study to which you might not agree if you were asked specifically about it.  However, the examples of possible research studies listed above should give you a good idea of the kinds of research projects that might be done.

What are the alternatives to taking part in studies?

You can use the Digital Clinic without being in this study. You may also take part in community-based standard of care for chronic and acute MSK pain or receive various other methods of treatment.

Where can I find study results?

To advance knowledge about chronic and acute MSK pain and treatment programs, we plan to release study results using de-identified data through presentations, white papers sponsored by Hinge Health, and peer-reviewed journals. You will not be identified in any publication, as we will use the collective data of all participants. These papers and articles may be posted at: https://www.hingehealth.com/resources/clinical-studies/. You will not be notified when study results are released, if new information about studies becomes available, or if new studies are launched.

What will happen if I don’t carry on with the studies?

You can withdraw from studies at any time and without any repercussions by contacting the principal investigator listed at the top of this consent information form. If you withdraw, the principal investigator will not begin new research uses of your identifiable personal information. However, your identifiable personal information will continue to be used in studies that started before you changed your mind.

Will I be paid to take part in research?

At times, you may be offered small tokens of appreciation for taking part in research. For example, we may provide a $25 gift card to thank you for completing a survey. However, no specific amount of payment is guaranteed.

How are studies funded, and who is paid to conduct studies?

Studies will be designed and funded by Hinge Health or partners. Hinge Health is being paid by your employer, health plan, or other host organization to provide this care opportunity to its employees and members, and some of this money is reinvested into research. Clinical researchers at Hinge Health have equity and receive compensation from Hinge Health to conduct studies. The use of your data may result in commercial profit for Hinge Health. You will not share in this commercial profit or otherwise be compensated for the use of your data.

Further Information and Contact Details

For questions, concerns, or complaints about this consent or the studies contemplated, or if you feel you have experienced a research-related harm, please contact the principal investigator, Mindy Hong, PhD, at mindy.hong@hingehealth.com / +1 (855) 902-2777 (24 hours).

An independent group called a Research Ethics Committee will review the research studies. If you have questions about your rights as a research subject or if you have questions, concerns, or complaints about the research, you may contact WCG IRB about IRB Protocol #20204196:

WCG IRB

1019 39th Avenue SE Suite 120

Puyallup, Washington 98374-2115

Telephone:  855-818-2289

E-mail: researchquestions@wcgirb.com

WCG IRB will not be able to answer some study-specific questions.  However, you may contact WCG IRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff.

Consent

By proceeding with my application for participation:

1. I confirm that I have read and understand the above information sheet, and have been provided with the opportunity to ask any questions I have.

2. I understand that my participation in studies is voluntary and that I am free to refuse to participate or withdraw at any time without giving any reason, without my medical care or legal rights being affected and without penalty or loss of benefits to which I am otherwise entitled.

3. I understand my participation in studies may provide no benefits, and may include risks, as described in the above information sheet.

4. I understand that the information provided during my participation in any studies, as well as information logged during my use of Hinge Health’s mobile application or sensors, may be viewed by individuals working on behalf of Hinge Health and, in aggregated form, by the organization offering Hinge Health. I also understand that personal and protected health information may be shared with certain entities, such as the US Food and Drug Administration, as explained in this consent. I give permission for these entities and individuals to have access to these records.

5. I understand that the information collected about me will be used in future research and may be shared with other researchers affiliated with Hinge Health. I understand that I may not receive additional information about studies or be asked to consent again to use of this information in any future research as it is covered by the current consent.

Authorization to Use and Disclose Protected Health Information

By proceeding with my application for participation I understand and acknowledge the following:

During my participation in these studies, Hinge Health and study staff will collect or create personal health information about me through my use of the Digital Clinic, including the Hinge Health app, sensors, or computer vision; and from other sources, such as health records or medical claims data. Hinge Health will keep this personal health information in my study-related records (that we will refer to as “my study records”). In addition, Hinge Health may obtain, and include in my records, information regarding my past, present, and/or future physician or mental health and/or condition. Hinge Health may ask me to sign a separate authorization to obtain some or all of my medical records from my doctor. My study records may include other personal information (such as social security number, medical record numbers, date of birth, etc.), which could be used to identify me. Health information that could identify me is called “Protected Health Information” (or “PHI”).

Under federal law (the “Privacy Rule”), my PHI that is created or obtained during these research studies cannot be “used” to conduct the research or “disclosed” (given to anyone) for research purposes without my written permission. This permission is called an “Authorization”. Therefore, I may not participate in these studies unless I give my permission to use and disclose my PHI by proceeding with my application with this Authorization. I am agreeing to allow Hinge Health and staff to use my PHI to conduct these studies.

By proceeding with my application with this Authorization, I am also agreeing to allow Hinge Health to disclose PHI as described below:

• Hinge Health and anyone working on behalf of Hinge Health to conduct these studies may have access to my PHI (collectively referred to as “Hinge Health”). Hinge Health will analyze and evaluate the PHI and may use it to develop new tests, procedures and commercial products.  Hinge Health may look at my complete study records that identify me.  In addition, Hinge Health may visit the study site to oversee the way the study is being conducted and may review my PHI during these visits to make sure the information is correct. 

• The Institutional Review Board ("IRB") may have access to my PHI in relation to its responsibilities as an Institutional Review Board.

• Hinge Health may disclose my PHI to the United States Food and Drug Administration ("FDA") or similar regulatory agencies in the United States and/or foreign countries.

These disclosures also help ensure that the information related to the research is available to all parties who may need it for research purposes.

Except for the disclosures described above, my PHI will not be shared with others unless required by law.  If my PHI is given to the parties listed above and/or to others who are not required to comply with the federal law, my PHI will no longer be protected by this law and could possibly be used or disclosed in ways other than those listed here.

I have a right to see and make copies of my PHI.  I am agreeing, however, not to see or copy some or all of my PHI until the sponsor has completed all work related to these studies.  At that time, I may ask to see my records.

This Authorization will expire 50 years unless I revoke (cancel or withdraw) it sooner. 

I understand this Authorization is voluntary. I understand that I may refuse this Authorization, and Hinge Health may not condition treatment, payment, enrollment, or eligibility for benefits on whether I proceeding with my application with this Authorization. I have a right to revoke my Authorization at any time.  If I revoke it, my PHI will no longer be used for this study, except to the extent the parties to the research have already taken action based upon my Authorization or need the information to complete analysis and reports for this research.  To revoke my Authorization, I must write to the Sponsor, stating that I am revoking my Authorization to Use and Disclose Protected Health Information.  If I revoke this Authorization, I will not be allowed to continue to be in these studies. 

I will receive a copy of this Authorization.