Telemedicine and Advanced Technology Research Center (United States Army)

Transcription

[...Is now being recorded] [Wendy Nilsen] Good afternoon, this is Wendy Nilsen at the, of the Office of Behavioral and Social Sciences Research here at the National Institute of Health. Hope you're having a lovely afternoon. Today I am very, very excited to introduce a wonderful researcher, a wonderful colleague and an ex-federal servant like us. Ron Poropatich is here, and he's the executive director for the center for military medicine research, health sciences at the University of Pittsburgh. Prior to this, he was deputy director of the telemedicine advanced technology research center in the United States Army and he was actually a colleague and friend to many of us here in D.C. doing really wonderful work. And I think, we're very excited to have you here today and I'm going to let you take it from there Ron. [Dr. Poropatich] Wonderful, well Wendy thank you very much for this opportunity. It's a genuine pleasure to be here among friends and to be back at NIH and to spend a few minutes talking about mobile health and the use of mobile health in rehabilitation. And I use that word 'rehabilitation' broadly to include any patient recovering in the home from a variety of illnesses. And so what I wanted to do in terms of starting of is, again, credit my co-investigators at the University of Pittsburgh on the second slide. Do I advance, will I advance or you advance? So, okay. So again the acknowledgements to my colleagues Dr. Bambang Parmanto, Walt Schneider, Anne Germain, Anthony Kontos, John Chmura, Dan Pultz, Norah Pearson, and David Okonkwo. We're involved right now in a DOD funded research project on traumatic brain injury and we've got a legacy of doing mobile health at the University of Pittsburgh where I've been for the last 2 years. And I was doing mobile health in the U.S. Army prior to this assignment to the University of Pittsburgh, but because of the preexisting work at University of Pittsburgh, we've leveraged a lot of the folks there to be involved now in this traumatic brain injury project. So I'm going to talk about over the course of the day. Can I have the mouse to drive my own slides? What I'd like to do is just over the course of the brief time I have with you all, is give you just a general overview on mobile health, talk about the University of Pittsburgh TBI project and how that evolved from other mHealth tele rehab applications, and then just spend a few minutes summarizing the efforts. It's important to realize that a lot of the causes of traumatic brain injury stem from trauma and trauma is the number 1 cause of death for Americans 1-44 years of age, it's the number 3 cause of death overall in the country, and trauma accounts for 41 million ER visits, a third of all life years lost, and the economic burden is over 400 billion annually and 180,000 people lose their lives to trauma each year. The, again, other points I wanted to bring out in addition to trauma, it's a common cause of traumatic brain injury. And traumatic brain injury is one of the key aspects of the tele rehab mobile health project I wanted to talk to you about. There are over 1.7 million a year sustain a traumatic brain injury with over 50,000 dying in the U.S. Causes primarily are falls, motor vehicle accidents, and I'm joined here at the NIH by Dr. Florence Haseltine as well. It's wonderful to have Florence as a colleague and friend talking about falls and TBI just before we started this lecture, in fact. But TBI is ubiquitous, every 20 seconds someone in the United States suffers a traumatic brain injury and males are 1.5 times as likely as females and the 2 age groups are the very young and those 15 to 19 and costs are very high and the CDC estimates that at least 5.3 million Americans currently have a long-term or lifelong need for help to perform activities of daily living in their normal environments. And again what I want to talk to you about is how do we personalize and provide self-management for those with TBI, trauma, PTSD in their homes and in addition to TBI and PTSD, we're over 5 million people in the United States are effected in the United States with Post-Traumatic Stress. And coming from 30 years in the Army as a pulmonary critical care doc and having seen a lot of TBI and PTSD in my military career, it's important to know that a lot of the projects that we've developed in the DOD and what we're doing at the University of Pittsburgh funded by the DOD has great relevance to the civilian community as well. But in addition to those key injuries, spinal cord injury is also a very common problem with over 50,000 deaths a year in the United States to spinal cord injury. Cerebrovascular accidents especially stroke and rehabbing in the home another key patient population. And then orthopedic and neurological disorders such as amputation in the military population. We've got close to 2,000 amputees. And again how do we use mobile health in the home with somebody that has an amputated limb that probably has TBI and PTSD? And how do we individualize and personalize the management in the home for individuals like that? So with that background just a very brief word on mobile health since I assume this is a very sophisticated audience. Again it's the use of mobile devices, both cell phones and tablets, to improve health outcomes, health care services, and health research. This was the NIH consensus group definition I have to use since I'm here at NIH, I figured I better use that definition. And again why mobile health? People don't adopt mobile devices, they really marry them and I bet there's not a person listening out there that does not have at least one mobile device. I've got at least two tablets and two phones and I see Wendy's holding two phones and one tablet and Dr. Haseltine's got her Google Glass. And so we've got all sorts of mobile devices and the good outcome is that we never feel alone that's our companion, it's a very useful tool. The bad outcome is we can never escape. We've got this constant nag and we've become addicted. We've got it next to our bed. We use it as an alarm clock and then people text us or call us and we get fragmented sleep. But there is an incredible opportunity, though, to personalize that mobile device. And how do we personalize it in the context of rehabilitation care? That's what I want to talk to you about. This is a slide that the Surgeon General of the Army, General Patty Horoho, put together a couple years back and it talks about a circle where, that circle comprises all the minutes of the year. So there's over 555,600 minutes in a year and a typical patient has roughly 4 patient encounters during a year, each one lasting roughly 30 minutes. So there you take 120 minutes out of that total 500,000 plus and we really are providing patients with a very limited opportunity. And the whole point is how can a mobile device connect a patient more fully to the health care team and to family members who are all working towards them getting better or staying healthy. So filling in the white space is what we talk about. And again the other key technology and capabilities that we talk about, it has to integrate with the electronic health record, I talked about social networking, the whole issue of smart bandages and sensors continues to evolve. Secure messaging is the best mechanism which allows us to exchange information in a HIPAA compliant way. With good outcome-based metrics, which is what we need and which I plea for in this talk, in order to come up with better understanding of the science of the use of mobile devices in healthcare. The mobile learning, or as we say in the military hip pocket training wehere I take up a phone and I look at relevant 3, 4, 5, 10 minute lectures, podcasts we're all used to, medical imaging on the phone now I can make diagnoses at a distance. Different web services, telemedicine etcetera. There's a lot of things we can do on a phone and so the approach that we take and that others take as well, but it's an important approach, it's all about self-management. How do I empower the patient to take charge of their situation? And scale it to various geographic locations and a variety of health conditions, many of which, you know, patients for example with diabetes or heart failure, often times those two illnesses go hand in hand. However, there are other things such as amputated limbs and polytrauma and TBI and PTS and a wheelchair and the difficulties of adjusting to a prosthesis. Putting a patient in a wheelchair. So there's a lot of unusual situations that we're trying to get our arms around in a cohesive plan that I want to share with you. The whole point is that we want to intervene, we want to monitor, and we want to stay engaged with the patient. And that engagement is hopefully going to increase the patient's self-care skills and improve outcomes by changing their behavior. Making them realize that we care about that. It's important that we talk about mobile health. We talk about the ecological momentary assessment and the ecological momentary intervention. By that I mean, when I am going to see a doctor and they say come back in 6 months, and over that 6-month period until I come back to the doctor maybe I've had insomnia, maybe I've had nightmares, maybe I've had new pain. How do I get my problems that are bothering me right now to my health care team? And that ecological momentary assessment is the whole point of now that you're having the problem, your health care team is aware of it today, we're going to do something about it as opposed to 6 months later when you come back to see me where that problem may or may not exist. It may be worse. So the whole goal of mHealth is personalization and interactive health services anywhere any time using a mobile platform. I've used this picture a lot in mobile health talks. I just love it from the New Yorker or babies in a bassinet and "Oh my god I just got born" but it's just as funny for me now as it is 4 years ago when it appeared in the New Yorker. And again what we are doing now on this DOD funded project for traumatic brain injury is targeted evaluation action and monitoring team for traumatic brain injury (TBI). So, it's funded by the DOD, monitored multiple interventional research trial designed to parse out the heterogeneity of TBI and identify evidence-based treatment protocols that are individualized to the patient. Each participant departs Pittsburgh with a customized toolkit on an iPad that they take with them, on their phone that will allow us to stay engaged with them. And I'm going to share with you what we're developing. When we look at TBI and team TBI it's a 6-month, they come and get evaluated, 6 months later they come back. During that 6 months when they're away, we customize their problems for TBI into a variety of trajectories so when they come to Pitt, we identify whether their traumatic brain injury has a vestibular component, an ocular component, some of them have difficulties with accommodation, cognitive problems where they have memory issues, short-term/long-term memory, processing speed, effective disorders, anxiety disorders, sleep problems as well as cervical/spine problems. And so what we've done is identified treatment pathways that go along those trajectories and those pathways are programmed training that we ask them to do. We titrate the programs and the training for specific intervention and encourage and ask them to continue to use it and then we monitor it real-time to make sure that those responses are being stored in the database and then seeing whether we're actually making a difference in their life. So this little schematic sort of shows you those trajectories, again sleep, anxiety, mood, vestibular, ocular, cognitive, migraine, general well-being if you will. In the middle of the imaging piece and this traumatic brain injury project is really focused on imaging it while looking at magnetic resonance spectral imaging, high definition fiber tracking which is a spinoff of diffusion tensor imaging. So the imaging piece is a key that goes onto the mobile platform so they can actually see where there's fiber breaks in their traumatic brain injured brains. They can show family and friends and other providers, along with a variety of tools, these trajectory tools if you will that are on the outside of the imaging. Part of the diagram that I'm going to share in a little more detail with you on. So this is our little logo for TEAM TBI. It includes the department of neurological surgery, the department of orthopedic surgery, the department of psychiatry at Pitt, as well as the department of psychology, radiology, as well as the center for military medicine research where I work. And so it leaves the question "so what do you have in the box, Ron?" So what we have in the box is a variety of items. Hardware, software, fitbit, a variety of things that they're all going to get. And again the software on this iPad mini is, some of it is under development and some of it has already been developed and I'm going to share some time with you on that. And again the approach is, the patient comes into our clinic for a week. They stay in Pittsburgh, they get consented, fall under IRB, they undergo a variety of imaging, neuropsych testing, sleep study, cognitive testing in the concussion clinic, blood work, etcetera. And after all that testing is done, we have a multidisciplinary panel gather in a large room and we come up with a specific, tailored treatment regimen for the patient. And that is all done during the adjudication phase of the evaluation and then we individualize and adapt a self-management tool on the mobile device. And that's what we give them. Those interventions are including sleep, vestibular exercises, cognitive rehab, wellness tips. And the important point is that these are self-assessments performed according to an individualized schedule that we know that the patient has other things going on in their lives and for us to say "do this at 10 o'clock every day" may not work well. Maybe they want it first thing in the morning, late at night, maybe they want it during their lunch break. And so all this is sort of sorted out and the key players are the patient, the patient's family, the health care team, as well as a coach. And so we've got ex-military health care providers that are coaching these individuals along with a health care team making sure that they're doing what we want them to do and helping to encourage them to be active participants. So the compliance includes an application, a log in. we check their clinical course and hopefully they're getting better. And then they get subjective feedback in terms of is it really helping? Over a 6 month period then they come back, we look at all of this as they're an outpatient, we're hoping to make early adjustments to their clinical situation and hopefully seeing improvements. So the participant goals for this toolkit is to improve the daily lives of participants via this genuine concern, this clinical intervention and follow on the CIFO. Clinical intervention and it's all about follow on, it's all about people reaching out. Even though technology is wonderful, it still requires a great deal of human interaction especially in a research study. And we want to demonstrate, again, genuine concern, trust, and retention in the program so we've developed training tools, scaffolding tools, communication tools to increase effective participation in the rehab program and to strengthen intervention effect. So what we've developed and what's in the toolkit software wise, we've got common trajectories and priorities that are already in place. We've developed a sleep tool, memory looking at both working and prospective memory, an anxiety and a depression series of tools that'll show you attention, cognition, and wellness tips. So that's already built and being used and in addition we've got these additional clinical intervention follow on areas such as vestibular and ocular exercises. We have those exercises identified, we're putting it onto an electronic medium right now. And so it's got a little introduction about this is the exercise you're about to do. Here's a video on how you do the exercise and then here's a PDF if you want a schematic of what it looks like. We've got pain migraine how-to videos such as good sleep hygiene, rehab tools, home exercises. Cognitive behav9ioral therapy or cognitive rehab therapy is a really difficult area. We looked at good days ahead, there's Luminosity, there's a lot of things out there and we found really a paucity of data showing really strong objective results in these kinds of mobile health tools that I'll talk about. Appointment reminders, anxiety/depression such as breathing training are also under development. So the support staffing on this project is really important to emphasize. This is a human supportive system with multiple interactions linked to monitor encouraged track involving family members, weekly FaceTime with key individuals. We kick off the formal study, we've done a pilot with 7 individuals already. The formal study kicks off on 25 August, a little over 6 weeks from now. It includes a coach for outreach, clinical coordinators supported by the research team with domain expertise in cognitive sleep, post-traumatic stress, vestibular, etcetera as you see on this slide. So the human element is key. If you look at the sleep and TBI piece called iREST again it's got the sleep diary, it's got the sleep tactics, sleep thinking and bed tactics, sleep briefing, a variety of coach techniques that's part of a project that we're doing right now in the military population as well with traumatic brain injury. So we're porting this software into this other program. So iREST which is the sleep app includes this ecological momentary assessment and intervention. So you discuss the problems with the patient while they're being experienced such as insomnia, not days or weeks later. It's called the mobile brief behavioral therapy intervention. So based on their sleep diary, we calculate their average sleep and average wake up time and auto prescribe a sleep prescription, when to go to bed, how long to stay asleep, when to wake up and based on their sleep problems we also provide related education materials. The sleep tactics I was referring you to such as restful sleep, stop thinking in bed, get rid of nightmares. They may come in not having nightmares, but over the course of 6 months develop nightmares, which is why this interaction with the health care team is critical because then we can push on to their local platform these kinds of tactics relevant to a new and emerging problem. And then just general education about sleep. So again it all comes with all of these kinds of mobile health tool with a dashboard and the printout. This is a real challenge to read, I understand, but the same things for sleep in terms of a dashboard, we've established for affect and mood, and this is being used in a variety of studies primarily in the pediatric population and we're porting that over to the adult population as well with very simple, you know, Likert-type scales of 0 to 3, you know, picking how your mood is and then monitoring that with a dashboard over time so that the health care team, the patient, the family can all see that. In terms of anxiety treatment, what were you doing when the phone beeped? Different things to key the patient. And we've used this, again, primarily in the pediatric population for child anxiety and this is a published article by Dr. Parmanto, who's part of our team, earlier this year in the telemed journal. In addition, ocular/vestibular is a big problem for TBI and again these are just examples of one of the 100 exercises we use for ocular/vestibular. So again we provide a PDF on how to do the training, videos of the exercises, and then we're going to have in 2015 mobile training applications using mobile gyros and cameras as well to expand that capability. This is the key architecture for our platform. Everything's going to be on one platform. So if you look at the communications of the iMHere Portal, it's got the directory services, the messaging services, and the database. That's all on the server. And on the patient's mobile platform, they'll have skin care, self-catheterization, MyMeds, it can work on an Android, an iPhone, or a Windows and to provide guaranteed deliveries, HIPAA compliance with the various encryptions that you see there, and allow complex payloads such as video/audio treatment regimens etcetera. And the other thing that's important is the social networking to enhance compliance. If you bring in that patient's family and friends, you can see where you see in this picture a smartphone that has a pedometer app on it and the patient, the user in the little green shirt. And then off to the right is the community of interest, the social networking that includes peers, and then peer support and peer comparison groups. And so how does that phone interact with the patient in terms of self-management? That's number one. Goal setting is an internal issue that drives the patient, hopefully changing behavior and motivating them. Self-monitoring their performance. Self-comparison, how they did this week versus last week. And then you get beyond the patient and the device and you get into their community of interest that they identified for peer support, peer companion, comparison, social support, and then social comparison for competition is an important aspect. And part of this social support we've developed PersonA, which tracks their activity and shares with friends and family to show that they are getting better hopefully with getting more steps in during the day comparing maybe with their siblings or their loved ones. Feedback comparison and social support again just to let them know how they're doing over time is the intent here, it's all built into this. And again when you look at all these applications out there razzed and built that maybe we can take something that's already available. There's over a million apps now out there and so here you see the picture of one million apps this was earlier this year. Giving someone an app that wastes rehabilitation time or is unused is to be avoided and monitored. We don't want to just throw random apps to our patients. They have to make sense to us and the patients. So giving them a low cost app without supportable expectation of benefit or monitoring is unacceptable such as overprescribing ineffective medications to patients, avoiding cognitive training, using underutilized interventions. There's a lot of things out there that we don't want to do. So what we're looking at under cognitive rehabilitation therapy, we've looked at all of the commercial products, we've pulled together a panel of experts, both industry, academia, and government. And we've looked at all the different products out there. We've also compared out list and our experience with what the U.S. Army did. They pulled together a team of experts earlier this year. Prepared a 78-page paper on all of these cognitive rehab tools. I think the bottom line is there's nothing out there that we found either in our internal panel with experts as well as the U.S. Army that's really built on good, solid data that's prospective, randomized study showing meaningful sustainable effect. So we feel there's limited data that has undergone rigorous study, but the key focus areas for the cognitive rehab piece, we're looking at short and long-term memory, we're looking at processing speed, and we're looking at executive and working memories. For example, can we improve their GRE scores? Can we improve their ability to do email with family and friends? The other thing that's important in post-traumatic stress is the whole concept of mindfulness and being able to find that inner-peace within yourself to sort through difficult times and to handle difficult times. And so there are some commercial products out there that I didn't want to bundle into these other cognitive areas, but some of the mindful products we found very helpful such as Posit Science and we're looking very closely at that. So again we want this software that we're either building or looking for commercially to be agile, to be opportunistic, to be integrative for common launching and monitoring and to be evolutionary. We want to try small things, try things in small groups and then pull away the poor performers. And so this is a constant iterative process. So the challenges and limitations, we don't have the evidence-based data to identify what works today and deliver successful intervention that will work on the typical person for today. So what research metrics are we using? You know for example, what mobile training program will enable a medically discharged traumatic brain injury case over 6 month training program to regain attention and working memory to succeed in reading for a job, such as doing emails at work. Education, can they successfully complete junior college? Can they get good scores to get into junior college? And then enjoyment in general in terms of pleasurable reading. Are these reasonable metrics? And so how do we leverage the mobile health development that has been going on at our university and other places in traumatic brain injuries, sleep, post-traumatic stress. There's a lot of data out there on chronic disease, heart failure, diabetes, etcetera. And put it into this broader context now of rehabilitation and rehabilitation care. So I'm going to show you just some of the work that we've done earlier in spinal cord injury. And what we want to do in the amputee population because many of these patients with TBI, PTSD have spinal cord or traumatic amputation. So when you look at where we've been, we've got again in TBI, memory, attention, and cognition as a key part of some of the key tools we're building. In post-traumatic stress you deal a lot with sleep, anxiety, and depression. This is where mindfulness as a tool comes into play. In prosthetics, we want to do at home gait monitoring, the machine-body interface, skin breakdown. A lot of guys don't want to wear the prosthesis because they're just not comfortable on it. They fall, so they're back in a wheelchair. We want to avoid that. And so we don't want skin breakdown so if I put pressure sensor, pressure temperature sensors in their prosthetic liner, can I prevent skin breakdown by understanding these problems earlier and doing something about it? And then looking at wheelchair use in terms of machine-body interface and skin breakdown. So here's an example of a Genium bionic prosthetic made by Ottobock. You can see that these prosthetics are extremely advanced with gyroscopes, two axis accelerometers, battery, hydraulics, Bluetooth, knee moment sensors, ankle moment sensors and axial load. I mean there's a lot of technology that goes into these. This is not a wooden peg, this is a very sophisticated piece of technology. And so how can I continue to monitor this patient at home? And so the sensor configuration was integrated with mobile devices and energy harvesting. So the energy harvesting piece coming from the heel strike on the ground powering the sensor in the prosthetic itself. And so these are the things that we're looking at and built into a research proposal so we've developed all this into a prospective randomized study for an amputee, lower extremity only, population that has been submitted to the DOD and we're waiting to hear if it's going to be funded. But it leverages on the mobile half that I've already talked to you about with TBI that I will be talking about on spinal cord industry. The data will flow to the phone that goes to a server then the provider-enabled home monitoring. It is so important to stress that you have to be able to have someone tracking this on a regular basis. So the challenge for example how do you monitor 3 prosthetics in an integrated way? So here's an individual with two lower extremity and an upper extremity prosthesis and again, these can get really challenging now when you've got 3 different prosthetics generating data trying to provide optimal performance in the home. There's also a lot of applications that we've developed that, again Dr. Pamanto is a wonderful investigator in this space. And who I would encourage Wendy to bring in to spend some time on a future webinar supporting self-care and management of chronic and complex spinal cord injury. And so Bambang is just a great guy and the problem with spinal cord injuries is you've got secondary complications such as urinary tract infections and wounds and these secondary complications lead to expensive hospitalization. So how do we promote a wellness program where a wellness coordinator, OT/PT/Nurse/community health worker, helps the patients do the self-care? And when we've studied this, it works well. The program pays for itself by avoiding these secondary complications. So another article published by Dr. Pamanto in the wheelchair population where you see again they have Facebook server, portal server, there's all sorts of sensors on the wheelchair and on the patient's arm in a wearable unit. And again they've been monitoring this and they published the results. It's in press right now for a publication that will be coming out later this year. And again it's two-way dynamic real-time communication. It deals with the patient and the family and the health care team. Has medication apps, it's got skin care apps already developed and this is where we're repurposing a lot of things that we've done in other populations and sort of bundling under rehab. Just like we bundle a lot of stuff under chronic care in mobile health. And so that's why I used the term 'rehab' I'm using it loosely. The secure messaging between the patient and the clinician as we've been doing in other apps is going to be important and again that kind of tele touch, that outreach to the patient will hopefully motivate them. So those mHealth components and tele rehab in general, that's critical here is the secure bi-directional communication, clinician supported self-care. That is really important for both medications and skin and wound care in the case of the amputated limb or in the case of the patient in a wheelchair. The secure messaging between patients and clinicians, sensor-based activity monitoring, and the continuation of successful remote monitoring features to look at both sleep, PTSD, cognitive behavioral therapy as well as personalized intervention. For personalized intervention there's deep breathing, there's certain things that we can repurpose where maybe, you know, in terms of relaxation and mindfulness, you want to get patients breathing right, doing diaphragmatic breathing as opposed to shallow breathing, which most adults tend to do. We don't focus on our diaphragmatic breathing anymore, which is what children do primarily, but that's just an example. This cognitive behavioral therapy game that we've developed called Thought Buster. Bad thoughts pop up and you've got to get rid of them. And it's you know you're playing around with your phone just blowing up bad thoughts and just keeping the good thoughts. And again, just games that might help some people and may not help others, but we need to personalize those kinds of apps because not everyone's going to want to play Thought Buster, but we need to identify those that might. So results from tele-rehab implementation. So what we've discovered is that patients have been using, actively and consistently, these apps for our spinal cord injured patients. Especially when that app supports their daily self-care tasks and that's important. Clinician-direcdted self-care support works. We've seen clinical outcomes that, again in press are already published. Patient self-management skills are improved when they have these tools. And then it's been scalable, we've been capable of supporting large geographic coverage areas in the Pittsburgh region and we hope to expand it to other areas as well. So in summary as I bring this talk to an end, I just want to finish by saying personalized self-management tools favor results that lead to behavior change. Emerging technologies such as sensors, energy harvesting will enable greater development of these apps. Continued research in mHealth is needed with well-defined outcome based metrics. We hope to contribute to that literature. And challenges in mHealth expansion continue. There's FDA guidelines that come out, there's a lot of different things, but I mean New York Times yesterday had a wonderful article on telemedicine and the compact and how we get across state lines and I tell you, I think this has been the most encouraging I've seen in terms of telemedicine whereby we're now starting to see congressional movement to get telemedicine more ubiquitous in our lives. So I'm going to stop there, I've left enough time for questions and comments and again I really appreciate this opportunity to share some of the things we're doing and would be happy to take any comments or questions. [Wendy Nilsen] Alright, thank you so much. I'm going to, all of our users please look at the question/answer screen and write your questions in there. I'm going to, but I'm going to take my prerogative here and ask a question. On your, I can't remember if you said you'd started with the sensors in the prosthetics? [Dr. Poropatich] We have not started. We have, some of these sensors are already developed in the liner, so we have patients that have used it. What we have not done is used it in a prospective randomized study and so that is, we've used them for just individual cases. So what we're trying to do is leverage some of the commercially available liners for prosthetics, Wendy that can then be bundled into a larger prospective study. This is, again, DOD sponsored research in orthotics and prosthetics. [Wendy Nilsen] I just think it's interesting because, you know, I think sometimes people are looked at funny when they're not using their prosthetics, but there's lots of reasons why they aren't using them and the sensors give an objective way to help people really communicate some of the difficulties they're having that might be very hard to verbalize. [Dr. Poropatich] And it may be also another way to come up with a better liner. So as we start studying it more, especially with pressure and temperature sensors, we hope to be able to come up with better materials that will allow better air movement, lighter weight, better fit. There's a lot of things that go into the decision of those liners and so we see this population as still being relevant in the civilian sector, but as you can see from my military experience it clearly touches the DOD population as well which is why I think it's a great fit in terms of DOD funding in an area that we feel very comfortable dealing with the same patient population that both groups see. [Wendy Nilsen] Okay, we have a question from one of our, from one of our online folks who says "would you talk a little bit about interacting with the patient at the time events happens? Like insomnia, is someone on call to do that?" [Dr. Poropatich] Yeah that's a great question. Unfortunately no one is on call that night when that event is occurring. It's going to be the next day in the morning. So at this point in time we've got dedicated people to take these kinds of calls from the patient. Unfortunately it's going to be a Monday through Friday, normal business hours that we're going to be interacting with the patients. So as you know from doing research between buying people to do this kind of thing and then paying the indirects in the fringe, the budget gets really big and we've already purchased 5 individuals for the study for this kind of outreach for the TBI patient study. So I think just because of the economics, we're limited in how often and how quickly we can respond to the patients, patients' needs. [Wendy Nilsen] Okay, and our next question. I think that's going to be interesting and I also think it might be interesting to see how much personal touch they do need at those times. Maybe reporting it will get them what they need. And show that we, when and when we don't need personal touch. [Dr. Poropatich] Yeah, and I think what we're trying to avoid is 3 nights in a row of nightmares with no one intervening. We're trying to avoid 3 nights in a row of insomnia. I mean if you get one bad night, you can usually take it especially if you know someone's going to intervene and give me some guidelines the next day or over the weekend. And I think a lot of people realize that it can't be 24/7, we're not there yet. But I think, hopefully it will help improve recovery by knowing that there's someone on the other end with genuine concern who they trust. [Wendy Nilsen] And is there any smart systems there that are providing information when there's no one on call? [Dr. Poropatich] No, we don't have any artificial intelligence that takes these sensors and then comes back with a way to study that individual. We're familiar with that process of taking data from the patient and then over time beginning to know that patient's needs where you can then come up with a computer-aided recovery plan for that moment, let's say. We would like to do that, but we have not yet reached the point where we can take all those data elements, put it into a software program that can come up with better, predictable and computer automated responses. We're not there yet. We're thinking it. We're thinking there, but right now we're just trying to identify the data elements. [Wendy Nilsen] Right, alright can you describe a bit more in detail what the main specific neuro cognitive rehabilitation tools look like? Aare they genes? What's the dose? How frequently are they administered? [Dr. Poropatich] Yeah, again there's a lot of stuff out there already. Good Days Ahead, Luminosity, and a lot of them are. The m-back is one example where you go back so many spaces, you'll see a screenshot of 3 different images in a 6-panel screen. And you'll have to identify on the next screenshot, whether those same 3 images that they're showing you in the next screenshot were the same on the last screenshot. And then were they in the same location on that 6-panel or 9-panel screen as they were? And so there's the end-back, there's the other thing we're looking at is reading comprehension where they'll be given small reading sentences, you know, 2, 3, 4, 1 or 2 paragraphs. It's a short reading test if you will. And then questions afterwards to help them hopefully improve their reading comprehension. We know that there's data out there that shows that when you have that kind of intense involvement in, for example, you have to re-certify in clinical investigation. There's a whole series of legal regulatory lectures you have to take. I mean after you immerse yourself in 8 hours of intensive training with online exams I kind of feel better afterwards. Or I feel like gosh I can think better because I've been training my mind the last couple days to work this way. We know there's data that supports that and we're trying to bring in good science into the cognitive behavioral therapy. So the end-back was one example, the reading comprehension is one example. We're trying to not make everything in house, we're trying to find validated tools that are already out there and it's been difficult. But I think posit science is one that we have good interest in because they've got some interesting tools. What's more important is we can port it into our platform. We own the data elements and it's not like I've got to give someone 2 usernames and passwords, one for our platform and one for a commercially available product that we're licensing. They're freely interested in sharing that with us, which is really important for us. We don't want to play unless we can leave it on one single platform that's fully integrated. So I don't know if that helped to answer the question, but it gives a couple examples at least. [Wendy Nilsen] WE have a question it says "can you tell" why do you keep changing it? I can't see what "can you tell" every time I try to read the question, it disappears. "Can you tell, can you tell the problem they're having from what they put on the device, or do they have to call you?" [Dr. Poropatich] Well, we want to be able to look, so we're going to look at that dashboard. We're looking at the data, so if we see something that's not going well, for example the patient may not call us, but we're seeing that they're not getting any better in some of their vestibular/ocular testing. We call them. That's why this is really human heavy if you will, in terms of cost and involvement. So we're not waiting for them to call us. If they call us, we will certainly intervene, but we plan to call them if we're not seeing significant improvements in whatever aspect of traumatic brain injury let's say, that patient may have. Whether it's ocular, vestibular, cognitive, cervical, anxiety, etcetera. [Wendy Nilsen] And I think the related question I'm going to give you "how do you determine when to have the clinician interact with your person versus, I know you have some staff that's doing a lot of the interaction, so how do you determine who intervenes and when?" [Dr. Poropatich] Yeah, you know when they come to Pittsburgh for their initial one-week evaluation, they get to meet all these people. And so when they leave and go back home, wherever it is, and again most of our patients are going to be military. These are all Marines and soldiers, so it's Army and Marines who are either on active duty or have just recently retired from active duty. And they're coming from all over the country. We, they'll meet the coaches, they'll meet the health care team. Not all of the coaches are physicaians for example, but I would argue that you don't want necessarily a physician as the only kind of person talking. There's important therapists that have important insights and skills that we want them, our sleep therapists are really quite good and we want them engaging with the patient. Not our neurosurgeon. I mean our neurosurgeon is wonderful, Dr. Okonkwo, he's the P.I. on the project, but he's not the guy I want talking to a Marine that's having sleep problems. We want the sleep therapist to be doing that or the neuro psych therapist dealing with the cognitive issues. Or the ocular therapist dealing with the ocular issues. And if we see that they're not doing these exercises, we have our counters. So when they leave Pittsburgh, we tell them look, you've got to do this schedule, these exercises and we're mindful of we don't want to overload them in any given day, so we'll stagger them over time. If weekly they're not even logging on to do those exercises, then we will call them and say "hey, what's going on? We just don't seem to see any interaction of you doing the things we asked you to do. Is there a problem? How can we help?" So there's that kind of active outreach from people that are health care individuals and those that are ex-military that understand the military speak. Close in age to the patients. [Wendy Nilsen] Alright, so then, and so one of our questions is "what patient-reported outcomes, measures will you be using in your study?" [Dr. Poropatich] Yeah, there's, well again for vestibular/ocular some of the testing you can do on an iPad. For example there's a visual field testing that's now available on an iPad that we've become familiar with that we can actually see if there's improvement in that. Are they actually using the exercises and is the visual field getting better? That's one in that particular regard. Is there less anxiety? So you can give them a Likert scale on anxiety or mood as we track anxiety and mood. And are they finding that it's getting better? Those are all things that we've identified as some of the metrics we're looking at in ocular/vestibular, anxiety, depression, the usual metrics. But the key is what tools can we give them? Do they actually use the tools? That'll be a metric. And do the tools actually help? And then when they come back in 6 months, we're going to re-image them to see if there's actually an anatomical improvement. If we know in traumatic brain injury, it's our hypothesis that there's a lot of these really small fiber tracks that are broken. And can we show, which we've seen in other patients that we've demonstrated this high definition fiber tracking on, you get this re-growth if you will. Some of these fiber tracks and areas of the brain. And so if we know that this area of the brain has significant fiber track breakage, can we provide tools that will improve that part of the brain through a variety of cognitive tests let's say. And when they come back in 6 months, the other metric would be is there actually significant changes anatomically in the brain? Now that's really, that's a hard thing to prove. But the high definition fiber tracking has been gaining greater and greater confidence. We're working with radiology specialists at Hopkins, Penn, Baylor. We've got a strong academic community we're working with NIH on this particular imaging modality. And so that's a big metric as well. We're not sure whether that metric i.e. the brain actually changed anatomy as a result of this intervention. An intervention on ocular, vestibular, cognitive that the patient actually demonstrated that they used on a regular basis. And so those are some of the metrics we're looking at. [Wendy Nilsen] That would be cool. [Dr. Poropatich] Yeah! [Wendy Nilsen] So, some of my data friends are asking questions one is "do you store all of the data while it's being generated?" and then the second part of that is "how does the data that you're generating get uploaded to the, how does it, if it does, get uploaded to the mod, the electronic medical record?" [Dr. Poropatich] Yeah, right now it sits on a dedicated server. So it's not being uploaded, it's a research server. So what makes it HIPAA compliant, it's secure, in other words it's encrypted both upstream and downstream. It's at least 256 des encryption, digital encryption system. It's sitting on a dedicated server and it's password protected. So we have all the data sitting on a research server only and nothing is being shared on the patients electronic medical record, nor are institutions' EMR. This is strictly a research project. [Wendy Nilsen] Okay, and then what kind of, what types of data are collected from your physical activity monitors? They're using the cell phone's accelerometer? [Dr. Poropatich] Well they get a FitBit, for example so we're all going to get a FitBit. So we're going to be looking at steps, how many steps did they take in a given day? The same data you get from your FitBit activity with sleep too. That's going to be primarily the FitBit providing the activity data elements if you will. [Wendy Nilsen] I'm interested in the discussion of your PTSD with the sleep. What is the, you said you had sleep tactics? I mean there were several things on the slide so it sort of quickly went by me. But the problems that people have with sleep, with insomnia, with nightmares and what are the therapies that you're using? Or I didn't even know there were sleep tactics, that's a whole new thought for me. [Dr. Poropatich] Yeah, Dr. Anne Germain of Florence is the key investigator for our sleep portion and she now runs the whole sleep research laboratories at the University of Pittsburgh out of the western side institute there. And Anne has got, and has developed and validated a lot of these tests. I don't know enough about them in great detail to tell you that if someone's having a nightmare, this is what we do to help prevent further nightmares or to help them through that difficult time. Anne has published quite a bit on that primarily in a military population. And again her last name is Germain and I can certainly get that kind of information and share it with you. [Wendy Nilsen] Yeah, you said I guess you said the slides are available at the end of the talk? [Dr. Poropatich] Yes, I'd be happy to share the slides. And again those slides are a contribution of all those people who I acknowledged all contributed to these slides, so it's a real team effort for TEAM TBI. [Wendy Nilsen] TEAM TBI is a real team so I will, for those of you on the call, I will be sending out a PDF of the slides afterwards and they also include Dr. Poropatich's contact information, so as you can see he's a great team player. So if you're interested in some of the things that he's working on, I'm sure you can contact him. So I think we're good for questions and I really appreciate Dr. Poropatich. I can't tell you how thrilled we are to have you back in D.C. even if it's only for a webinar. But this is the end of today's mHealth webinar series, distinguished speaker series at NIH. Please join us again next month when we're going to be having a webinar with our colleagues at FDA on the mHealth guidance. So thank you very much. [Dr. Porpatich] Thank you.