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.

Digital Musculoskeletal Clinic Efficacy

TITLE: Efficacy and Effectiveness of a Digital Musculoskeletal Clinic

PROTOCOL NO.: None (IRB Protocol #20204196)

SPONSOR: Hinge Health, Inc.

INVESTIGATOR:

Grace Wang, PhD, MPH

455 Market Street, Suite 700

San Francisco, California 94105

United States

STUDY-RELATED PHONE NUMBER(S): (855) 902-2777 (Monday to Friday, 6AM to 6PM PST)

Introduction

Muskuloskeletal (MSK) pain is a leading cause of pain and disability worldwide. The causes of acute and chronic MSK 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 MSK pain, self-management techniques may provide a powerful way to manage and reduce pain. 

Hinge Health is looking to redefine the delivery of best-practice care for musculoskeletal pain. Right now the best available care for musculoskeletal pain involves:

1. Exercise therapy

2. Learning about the condition

3. Behavioral changes

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

The investigator, Dr. Grace Wang, has received private equity from the Sponsor, Hinge Health, Inc. Please feel free to ask any further questions you might have about this matter.

What happens to me if I agree to take part in this research?

There are five programs in the Digital Musculoskeletal Clinic app that you may be eligible for: the Wellness Program, Acute Program, Chronic Program, Expert Medical Opinion program, and/or Surgical program. Depending on the program, you may be provided with educational articles, be assigned a physical therapist for virtual physical therapist sessions, use biometric sensors that interact with the Digital Musculoskeletal Clinic app for use during exercise therapy, or have an opportunity to connect with an expert physician for secondary medical opinions on elective musculoskeletal procedures. About every 3 weeks to 2 months, you will be asked to complete health surveys electronically.

If you are not eligible to enroll in at least one of the programs or if you decide you are not interested in participating in the programs, you can still be part of the research by agreeing to complete health surveys electronically about every 3 weeks to 2 months for up to 2 years.  

What kind of studies might you conduct?

We believe research is important for helping us improve the best-practice care recommended for MSK pain and its delivery. Hinge Health has carried out several trials indicating that digital care delivery can be an effective means of reducing chronic lower back and knee pain and stiffness while increasing function. We want to expand that evidence by conducting more studies on an ongoing basis. The studies will help us make sure that the Hinge Health pathways are as effective as they can be for improving outcomes. Studies will also help ensure that your experience with Hinge Health is as positive as it can be. Your participation in this research will last up to two years after you stop engaging with the Digital Musculoskeletal Clinic for follow-up. We expect at least 425 participants will be in this research.

Possible research studies include:

Correlation studies. These studies look for relationships between factors and will be done for participants in the Wellness, Acute, Chronic, Expert Medical Opinion, and Surgical 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.

Or, we may randomize one group to receive a Hinge Health program right away. Participants in a second group will be placed on a waitlist and will continue to have access to the existing healthcare options under their insurance plan, minus Hinge Health. Those in the Chronic program may be randomized to a waitlist for 12 weeks, and those in the Acute and Surgical programs maybe be randomized to a waitlist for 6 weeks. After the intervention, we will compare the outcomes of the two groups to determine the effect of the program. Participants who agree to remain on the waitlist get priority access to future deployments of Hinge Health.

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 and collaborators are all trained in the requirements of conducting research with human subjects. 

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 MSK pain and Hinge Health. We may gather information through your use of the Hinge Health app or sensors (Chronic and Surgical pathways only). We may also combine your data with information from other sources, such as health records or medical claims data. 

When analyzing compiled information, we will use a number that does not use your name or other personal identifiers. We will not share the identifiable information with parties unaffiliated with Hinge Health. 

Will my data be kept confidential?

The confidentiality of your data is extremely important to us but can’t be guaranteed. The sponsor of studies, Hinge Health, ensures that the handling, processing, storage and destruction of data complies with all applicable laws, rules and regulations. The information may also be given to the U.S. Food and Drug Administration (FDA). It may be given to similar governmental agencies in other countries.  Medical records that identify you and this consent form may also be looked at and/or copied for research or regulatory purposes by:

• Department of Health and Human Services (DHHS) agencies,

• the institution where the research is being done, and

• WCG IRB.

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

The benefits from receiving best practice care, whether digitally or in-person, may include reduction in pain, reduction in stiffness, improvement in function, and (if appropriate for you) some modest weight loss. You may also find that your mood and general wellbeing improve. However, the effects vary from person to person, and you may not experience substantial improvements. You may not receive any benefit for being in the study.

Participating in the study does not present substantial risk. Participating in exercise therapy may lead to some temporary pain and discomfort. There may be a loss of confidentiality for being in this study. If, for whatever reasons, you unexpectedly experience any ill effects, your care provider may recommend you withdraw from the study.

What are the alternatives to taking part in studies?

You may be able to use the Digital Musculoskeletal Clinic without being in this study. You may also take part in community-based standard of care for musculoskeletal pain.

Where can I find study results?

To advance knowledge about MSK pain and treatment programs, we plan to release study results through presentations, white paper 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 will be posted at: https://www.hingehealth.com/outcomes. You will not be notified 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 with the contact information on the top of this consent information form. 

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.

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

Studies will be designed and funded by Hinge Health. Hinge Health is being paid by your employer or other host organization to provide this care opportunity to its employees. 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 be compensated for the use of your data.

Further Information and Contact Details

For questions, concerns, or complaints about the study, or if you feel you have experienced a research-related harm, please contact the principal investigator, Grace Wang, PhD, MPH at grace.wang@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, such as questions about appointment times.  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:

1. I confirm that I have read the above information sheet.

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 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 Hinge Health employees and, in aggregated form, by the organization offering Hinge Health. I give permission for these individuals to have access to these records.

4. I understand that the information collected about me will be used in future research and may be shared in a deidentified way 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 future studies.

5. I understand that research results will not be shared with individuals. I can access compiled results and reports on the Hinge Health website.

California Experimental Subject's Bill of Rights

Any person who is requested to consent to participate as a subject in a research study involving a medical experiment, or who is requested to consent on behalf of another has the right to:

(a) Be informed of the nature and purpose of the experiment.

(b) Be given an explanation of the procedures to be followed in the medical experiment and any drug or device to be used.

(c) Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment, if applicable.

(d) Be given an explanation of any benefits to the subject reasonably to be expected from the experiment if applicable.

(e) Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits.

(f) Be informed of the avenues of medical treatment, if any, available to the subject after the experiment or if complications should arise.

(g) Be given an opportunity to ask any questions concerning the experiment or other procedures involved.

(h) Be instructed that consent to participate in the medical experiment may be withdrawn at any time, and the subject may discontinue in the medical experiment without prejudice.

(i) Be given a copy of a signed and dated written informed consent form when one is required.

(j) Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.