HERO Study Interest Form

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oTf3c9fqxvHxZCiUHgcAL4n4tsdDzt34hDGZuIEBpzoMDHi5Svbrqh4RSVnbU7kSfSMYn2HRNkbZ9H9EQUz9XXCXkedYkT4hw25GiAH2

Please complete the survey below to express interest in joining the "HRV Biofeedback for Enhancing Autonomic Rehabilitation and mTBI Outcomes" (HERO) Study.

A member of the research team will reach out to you as soon as possible.

Thank you!

A research team at VCU Medical Center is recruiting for a Clinical Trial for military veterans and active service members who have experienced a mild traumatic brain injury or concussion.

The purpose of the study is to learn if a new therapy for treating lasting concussion symptoms is effective. This therapy is called Heart Rate Variability Biofeedback (HRV-B). The project is being led by James Burch, Ph.D. and William Walker, MD and is supported by funding from the Department of Defense. Participants in this study are assigned to one of two groups. One group learns HRV-B and the other receives state-of-the-art education on managing lasting concussion symptoms. Participants are asked to complete 9 in-person visits: a baseline visit, 6 weekly training sessions, 1 after-training visit, and a final follow up visit 1 month later. Participants are paid for their time and contributions. Your name, address, and other personal information would be kept strictly confidential. You do not have to participate in this study to continue receiving routine care as a patient in your medical facility.

First Name

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Last Name

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How can we reach you? Select all that apply.

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Phone

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Best Email Address

Best Phone Number

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I agree that the research team may contact me via phone call.

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Yes

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Pre-Screening Questions

1. Are you 18 years old or older?

Yes/No

2. Are you comfortable communicating in English, both in speaking and writing?

3. Have you ever had a concussion (mild traumatic brain injury)?

a. If yes, when was your most recent concussion (mild traumatic brain injury)?

i. **If less than a year, continue screener but if they pass all other eligibility criteria mark as not currently eligible, recontact

4. Are you currently having any symptoms or problems that you feel are coming from one or more of your prior concussions?

5. Do you currently have a pacemaker or an implant that stimulates your heart (e.g., cardioverter-defibrillator or ICD)?

6. Have you had a heart transplant or heart surgery within the last year, including bypass or other surgery?

7. Have you ever been diagnosed with any of the following mental health conditions?

· Dementia

· Psychotic disorder, or

· Panic disorder

8. Are you currently pregnant?

a. **If pregnant, continue screener but if they pass all other eligibility criteria mark as not currently eligible, recontact

9. Are you currently incarcerated?

10. Have you ever practiced heart rate biofeedback, either by yourself or with a professional?

11. In the past week, how much were you bothered by a lack of energy because of poor sleep? Not at all bothered, slightly bothered, moderately bothered, or severely bothered?

12. Over the past week, how would you rate your satisfaction with your sleep? Excellent, good, fair, or poor?

13. This study involves nine in-person visits. Are you willing to come to VCU Medical Center in Downtown Richmond for 1-3 hours per visit over the course of 11 weeks and complete at-home activities each day for approximately 5-20 minutes a day?

This individual appears:

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Potentially eligible.

Not eligible

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Continuation Status

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Proceed with consent- Participant appears eligible and would like to enroll.

Not proceeding with consent- Participant is not eligible.

Not proceeding with consent- Participant declined participation.

Recontact at a later date- Participant may become eligible in the future.

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Notes

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Date to recontact (if applicable)

M-D-Y

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