There are more than 2 million adults living with congenital heart disease in the US today. Guest speaker Dr. Jamie Jackson, with Nationwide Children's, explores how pediatric specialists can support this patient population into a healthy adulthood.
Phoenix Children's Grand Rounds - March 28, 2023. CME credit provided only for participation during live sessions.
Yeah. Ok. We'll go ahead and get started. Maybe a few more people who um trickle in or, or logged on online. Thank you all for joining today and joining remotely. Uh It's my pleasure to um welcome our guest speaker today uh on behalf of the cardiology division and the division of psychology led by the Chief Doctor Carla Allen. We'd like to welcome you to pediatrics, uh grand rounds for clinic, children's. And today, our guest speaker is uh Jamie Jackson. She's a principal investigator in the Center for Behavioral Health at the Abigail Weaver Research Institute at Nationwide Children's Hospital in Columbus, Ohio. She's an assistant professor of pediatrics and Psychology at the Ohio State University. Uh She's also a licensed clinical health psychologist and I just learned yesterday, you know, Jamie has a lot of um experience in training and in cardiac behavioral medicine. She actually did several years of training both at Brush and at Northwestern and then at Ohio State and nationwide in cardiology and specifically in um cardiac transplants. Uh Her research interests include promoting healthy lifestyle engagement for adolescents and adults uh with heart disease through behavioral interventions. Uh She's currently the associate editor for the European Journal of Cardiovascular Nursing and serves on multiple national committees including the American Heart Association and the American Cardiology. And she's a member of the Medical Advisory Board for the Adult and General Heart Association. Um I think it's a fantastic topic. She's gonna talk to us about this morning, especially with her interest in, in clinical psychology, particularly for uh Children and adolescents with chronic disease. So without further ado, Doctor Jamie Jackson, thank you. Hi, good morning, everyone. And thank you so much for that introduction, Wayne. And uh I just wanna thank you and Carla for that the opportunity to be here with you all this morning. Um See if I can. Oh, there we go. That's my slides a little bit. Um I was actually born and raised in, in Glendale and I haven't been back here since 2017. So this is a particularly special opportunity for me to, to come back home and be with you all this morning. So, thank you so much for that. So I just wanted to start with a statistic that is probably familiar to a lot of you that congenital heart disease or CHD is present in approximately one in every 100 life burns. And thanks to medical advancements including earlier detection of CHD um enhancements in surgical techniques and materials uh as well as just enhancements in the medical care overall, the management of CHD, we now have over 90% of these individuals living well into adulthood, which is fantastic. And that brings me to another statistic. So here in the United States, now we have over 2 million individual adults with CHD living here alone in the US and that number is continuing to rise. So um before we go on for any folks who are listening, who maybe aren't in cardiology and maybe don't have um as deep of a knowledge about CHG, I wanted to just do um a little quick overview of some different forms of CHD in part because it has relevance to some of the my work that we're gonna be talking about um a little bit later. So it's not uncommon for us to communicate about CHD as falling within kind of a classification system of simple, moderate and complex. So I just really quickly wanted to review some of that for you this morning. So for folks with simple conditions and this by no means are going to be an exhaustive list of all the different forms of CHD that are included in these categories. But I just wanted to give folks a little bit of an example. So simple forms of uh CHD can include things like isolated, small atrial sepal defects. A SDS, isolated small ventricular septal defects or B SDS and then repaired second to A SDS or B SDS without significant residual shunts. Now, a hallmark feature, I think of a lot of, you know, simple forms of CHD is that they either don't require surgical intervention or there is a lower need risk for surgical intervention among these groups. And among the classification systems, these are also the folks that have the lowest risk for significant neurodevelopmental uh difficulties. Then we move on to the moderate category. This is actually um quite an extensive category of lesion types that fall within. Um you know, the the moderate um category of CHD but just to name a few atrial ventricular septal defects are included Epstein of the aorta and a repair topology of below are just a few. So, among these, now we're talking about usually an enhanced risk for need for surgical intervention, um sometimes immediately after birth as in the case, sometimes with and and again, an increased risk for neural pore neurodevelopmental outcomes in this group. And then that takes us of course to the complex solution type category which include things like diagnosis, low. Um you know, blood saturation levels, single ventricle conditions, transposition of the great arteries as well as mitr and pulmonary atresia. Again, just to name a few. And here we're talking about folks who necessitate surgical intervention, usually typically shortly after birth and then the highest risk for neural neural developmental outcomes. So the prevalence of CHD, what we would think of across these different um disease risk categories varies depending on what papers you're you're looking at. But some estimates approximate that. Um for simple, it's around 58% of CH DS fall within that category, approximately 36 moderate and approximately 5% in complex and V SDS are, in fact the most prevalent form of CHD. So I'm also reviewing this in part to drive home the point that this is an extremely heterogeneous group of patients. So you can take two individuals with the same diagnosis. Let's just hypothetically say pulmonary Trisa with a hypoplastic quite spec oh, ok. Um Same surgical history, a bidirectional blend with a Fontan procedure, same age, but you're not necessarily going to get the same outcomes in those two patients. One patient could have good exercise capacity on an exercise stress test. They could have mild or no cyanosis, they could have no device again, same diagnosis, surgical history age, you could have somebody who presents with poor exercise capacity. They are in fact cyanotic and they have an I CD in place. And so what this suggests is that, you know, their anatomy, the lesion alone is not solely responsible for the outcomes for these patients. There's a tremendous amount of heterogeneity and one of the I I think key factors in research is trying to identify how can we predict what some of these four outcomes are going to be. And from a psychologist perspective, that also plays a role in us thinking about what types of behaviors or controllable factors might we be able to influence that could also play a role in these outcomes. So there was a, a fairly recent paper by Britain and Gonzo that I think had kind of a striking quote in it that I wanted to share with you this morning. They say we are faced with a tsunami in terms of adult numbers, DH D numbers, the number of patients that we're encountering the disease, heterogeneity of this group and the complexity of work and interventions that are needed. And I think that idea of a tsunami really kind of draws home. The point of this onslaught of not only the numbers of individuals who are, who are coming to us that need care as adults. But also again, the complexity of uh the care that is needed as those individuals present for treatment. Part of the complexity of what these patients are presenting with are in fact acquired heart disease factors, right? And so one paper has estimated that patients with CHD were presenting about 34% had hypertension, 40% obesity and 14% were coronary artery disease. So significant concerns in this aging population is continuing to grow. There's also some research that suggests that a sporadic precursors have been found in Children with CHD, which is of concern and there have been increases found in hospitalizations for coronary artery disease. And a lot of these patients that are presenting for hospitalization have at least one if not more medical comorbidities. Ok. So again, feeling that deny of this growing population, but there's good news things like hypertension, obesity, coronary artery disease, these things have something in common. They are potentially modifiable with lifestyle change. And that's kind of where the psychology piece of this starts playing a role. So for me, I like maybe a different metaphor instead of the tsunami. I like to think of this, maybe as a storm, an impending storm, it's scary, it's looming. But with a storm, I feel like we can actually build a shelter in order to get through this event that we can actually do something about it that we can act on this. And so as a health psychologist, this is where my interests lie and how can we modify the things that we actually can control to change the trajectory for some of these patients as they age. So we talked about lifestyle factors. Well, what do I mean by that? Well, really when it comes down to it, I'm talking about health behaviors. And when I say the term health behavior, there's probably a lot of different things that come to mind for you, right? So these things are probably physical activity, for example, we know we should be physically active diet, being a very generally healthy diet is what we're we're told to do to try to stave off some of these conditions, getting appropriate amount of sleep, good quality sleep. And of course, either limiting or avoiding the use of certain substances, caffeine, tobacco, nicotine, right? Things like that for che patients. We also have to consider though that there are additional health behaviors that are also importance. So these individuals really should also be um continuing outpatient follow up, right. Continuing to, to check in with their cardiologist for the recommended guidelines for care. Also, ideally, they'd be engaging in regular surveillance and whether that means getting echoes when they're supposed to have echoes, stress tests, when they're supposed to have stress tests or getting their devices interrogated um regularly and then also medication adherence for those who are taking medication like antiarrhythmics or blood centers, for example. Right. So there's a whole host of things that we really could try to tackle in service of trying to uh modify these acquired heart disease factors that are certainly becoming a burden on this population as they're aging today though, I'm gonna focus on physical activity and this has really been the culmination so far for me for about six years of work and probably at least another five more. Um in some of my research as I'll be talking about in a little bit. So I had kind of the option of trying to pick one or more of these health behaviors to intervene upon. Why did I pick physical activity, physical activity is one of these health behaviors that we've got a lot of good data to suggest that if we increase levels of physical activity, we can really make a difference health wise. What do I mean by that. Well, first and foremost, we know that if we increase physical activity levels, we're also going to improve our exercise tolerance, exercise tolerance is directly connected to mortality in CHD. And so we know that if we can improve exercise tolerance levels, this could really have meaningful clinical impact on individuals lives as they age. We also know that physical activity reduces risk for hypertension, dyslipidemia, coronary artery disease, all these kind of acquired heart disease factors that once again, we're concerned about as this patient population ages. And we know that we can reduce these factors in the general population. Therefore, it makes sense that we could also do that within CHD as well. And lastly, we know that physical activity also aids in managing stress. And as a psychologist, especially one that has spent a lot of time in cardiology, I'm acutely aware of the fact that chronic overstimulation of our autonomic nervous system has a wear and tear effect on the cardiovascular system in the general population. We don't have research on that in particular within CHD. But it makes sense that it with physical activity being something that we can reduce that chronic autonomic nervous system activation. It could also work in favor for folks with CHD as well. So basically, there's a multitude of benefits of increasing physical activity and the evidence is just really strong. So before I move on from that, let's just kind of all get square on how much physical activity are we supposed to be doing? What are we talking about here for guidelines for physical activity? So, if you're between the ages of six and 17, you're supposed to be doing 60 minutes of moderate to vigorous physical activity per day. And what do we mean by moderate to vigorous, well, moderate levels of physical activity is anything that's gonna get your heart rate up a little bit. You can still have a, you know, say full sentences while you're working out, but you can feel that you're breathing a little bit harder. So risk walking actually would qualify as mode levels of physical activity and anything up from there. Now, you're starting to approach vigorous and we're also encouraged in a as adolescents, um and Children to do a variety of forms of physical activity, including strength cardio as well as stretching. Now, thankfully, us as adults, we get a little bit of a break. We don't have to do 60 minutes on every day on average instead. Now we're only asked to do um 100 and 50 minutes per week. So something just kind of magically happens once you turn 18, those guidelines change for us and now we only have to do 100 and 50 minutes for the week. Now, if you only engage in vigorous forms of physical activity, you actually can even cut that down further to 75. If you're, if you're really engaging in hard physical activity and of course, we're also supposed to still keep up with our stretching and our strength training as well. Ok. Well, what about NCHD? What do the guidelines say there? Well, in 2013, there was a American Heart Association scientific statement that came out, um, that had a quote here that I thought was um, pertinent to today's discussion. They said Children and adults with CHD should be encouraged to achieve recommended levels of physical activity, Meaning the general guidelines of physical activity. The rest of us are recommended to engage very few patients with CHD will have disease that significantly impacts physical activity with friends and family. OK. So basically, on average, most folks with CHD should be engaging in the same amounts of physical activity as the rest of us. It's that easy then, right? Like he said, it best just do it then, right? We know it's good for you. We've got all this data to suggest that this is what we should be doing, aren't we all doing it? Well, I think everybody in this room knows that it's not necessarily that easy, right? And it's not necessarily that easy actually starting at an earlier age than maybe we thought. So there was a paper by Casperson um and it's a little bit older, it's, you know, back in 2000. But I think the data um that they have described are still applicable today and this is data collected from a national um health survey interview and what they found is that physical inactivity starts pretty early. So you start getting this rise in physical inactivity or more sedentary behavior starting in high school like around the age of 14 to 15. And this doesn't improve over time. In fact, it gets a little bit worse for the most part as people age on average. Now, the kind of the a similar pattern emerges in the sense that for regular sustained physical activity, you also start seeing a decline in adolescence again around high school age. And that decline also tends to carry forward into adulthood as well. So a little bit of a grimmer picture than what we would ideally like to see in the general population. Another thing I wanted to highlight is that they also found significant differences between males and females with females being more inactive and less likely to be as active as males. So what about in CHD? Well, if you dive into the literature like I have, you will find that the results are really equivocal. There are plenty of literature out there to suggest that folks with CHD are as active as the general population and actually a majority of them are meeting these guidelines which by the way, are adopted also by the World Health Organization. So even in Europe, folks are asked to do the same amount. Um So what's going on and then you have another group uh that basically says, no, they're, they're less physically active. Well, I think there's a few things at play here. First, there's variable methods that are being used in measuring physical activity. And there are quite a few studies because this is the easiest way to do it is to just ask people how physically active are you? And there are plenty of self report measures out there that have been validated, um, that folks can use and, and certainly, you know, there's nothing wrong with using them. However, there's also research to suggest that people have this terrible tendency to overestimate their physical activity. And there's also some research to suggest that that's true in CHD specifically as well. So the difference between using self report measures versus objective forms of measuring physical activity, which I'll talk about a little bit later as part of my research that could be responsible for some of these equivocal findings. The other thing is that a lot of the research that's done in this area is actually done in Europe and there are cultural differences between physical activity levels in Europe and what we see here in the US, with us being less physically active than a majority of these countries in Europe for which these uh findings are coming from. Now. Some of the limited amount of data that has been conducted here in the US suggests that Children and teens with CHD actually engage in less moderate to vigorous physical activity as compared to controls, which is certainly not what we want to see. Given some of these concerns about this pattern of physical activity continuing into adulthood and that looming storm of acquired heart disease factors. So why, what's going on here, you know, are, are cardiologists telling patients to be physically active. Certainly they are. There's some anecdotal evidence that suggests that both parents and patients are hesitant about being physically active, they're scared. And if anybody in this room has gone from not being very active to trying to be very active, you probably realize you have a lot of cardiovascular symptoms that emerge when you first try to really do physical activity. So you get palpitations, shortness of breath, maybe even tightening in your chest, maybe that's partly responsible. You know, a lot of folks will also say that their cardiologist will tell them to self limit and patients will tell us that they don't really understand what that means. So does that mean if I'm uncomfortable at all, I just need to stop or can I push myself? And I think that some of those patients don't ask the questions back to the cardiologist to to to get more information from that. But again, this is all anecdotal. So some of you may be thinking, ok, well, you know, there is a cardiac rehab model out there and it works and it certainly does. And the cardiac rehab model is three days a week of going in having an instructor, basically tell you what to do, like what, you know, heart rate to target on the treadmill, you know what to do for, you know, your strength training and you do that three times a week for 12 weeks. And we know that it works. And so both in the general population, for folks who have acquired heart disease, who go into cardiac rehab and for Children, adolescents and adults with che who go into cardiac rehab, we know that it significantly increases their exercise tolerance. However, this model doesn't work great for prevention because insurance doesn't pay for cardiac rehab for prevention because it's rehab, right? Rehabilitation after an event, right, you're supposed to be doing this. Um And so if again, if we're really wanting to target acquired heart disease factors that are looming, that could occur as folks age, this is not going to be the model that we can really stick with. There's also limited evidence to suggest that the gains that occur during cardiac rehab are actually maintained after cardiac rehab, they're certainly maintained for a period of time. But how long are those maintained? And because we also know from the general population for folks with acquired heart disease who do um cardiac rehab, their physical activity levels decline very quickly post rehab. And so inevitably the improvements that they had um gained in their exercise tolerance over time also likely diminish that once they leave cardiac rehab, no one's encouraging them, you know, telling them what to do how to do it, what heart rate to target they're having a harder time sustaining that. So where does that leave us? Well, this is where I became really interested in this idea of lifestyle change, which is a little bit of a different model than that cardiac rehab model in that it's no longer prescriptive. This is really where we're trying to encourage patients to, to develop a new routine, new habits changing how, how they engage in physical activity in a way that they actually incorporate it within their daily routine and they no longer need ongoing supervision. In order to do it, they have the tools and the resources in order to do these things on their own. So that is going to then bring me to start a discussion today about some of the research that I've been doing for um the last several years. So I want to introduce to you a study that um we have recently concluded and, you know, at the end, just a little foreshadowing, I'll talk to you about some of the next steps of this research for me as well. But I want to talk to you about the congenital heart disease, physical activity lifestyle study, which was a randomized behavioral trial that we did. In order to see if we can start instilling some of this lifestyle change, that again, we hypothesize could be the key in order to help folks actually make sustained lifestyle changes in their levels of physical activity. And so I have received um a career development award that allowed me to examine this uh particular intervention, develop it and and examine it within adolescence. And we chose 15 to 18, that high school range. In part based on that Casper data that I had showed you where that's the period where where physical activity starts declining. And then I received another little small pot of money um in part due to the to the career development award in order to also look at this within young adults 19 to 25. Because again, we know that that's still the period where that decline is continuing um to, to be problematic. So the aim of this particular study was to first determine whether it was feasible to even conduct a physical activity lifestyle study. And then to examine the preliminary efficacy of this intervention, which was a video conference delivered physical activity lifestyle intervention um for both young adults and adolescents with moderate and complex forms of CHD. And we targeted folks with moderate and complex forms because once again, these are the individuals who are really at risk for problems down the road for reintervention and with the potential for neurodevelopmental um issues as well which could impact um their performance in some of these health behaviors. OK. So let's talk a little bit about um what happened in the study. So as part of baseline, so just bringing people in um to determine whether or not they were eligible for the study. We first gave them an online survey where they completed information about their demographics, their sports involvement, their attitudes towards physical activity, as well as various patient reported outcome measures. Um such as like the quality of life, we then had them do um a stress test and this had kind of a twofold um reasoning behind it. One was to confirm safety. So we wanted to make sure that we could establish that yes, in fact, they could engage in at least moderate levels of physical activity. But we also wanted to collect their exercise capacity as data. And lastly, we have to wear an accelerometer. And I always love this picture. She looks very proud to be wearing that accelerometer. Um The accelerometer is the objective measure of physical activity. And this is in fact, the gold standard for how we measure physical activity in an accelerometer is basically a fancy pedometer that you wear ideally around the waist. And it essentially assesses movement in three directional planes. And it estimates the amount of mets or by force by which you're moving within those three directional planes. We asked participants to wear this for seven days like an entire week and 12 hours a day. So a, a decently long period of time. MVP A was our primary outcome. That's what we were targeting. Can we just get folks to be more physically active? We were also though interested in collecting information on sedentary behavior as well from the accelerometer. Ok. So there's quite a laundry list of um inclusion and exclusion criteria that I I won't bore you all with this morning. Um But in addition to having the basic, just so you have an understanding of who is eligible to kind of proceed on to the to the RCT. I also, so age was obviously one thing for recruitment. They had to be between the ages of 15 and 25 they had to have moderate or complex forms of CHD. Now, if when we get the accelerometer back at baseline, they were already meeting the federal guidelines. So at least 60 minutes for teens or 100 and 50 minutes per week for young adults, they were not eligible to proceed with the RCT. If they were identified to have any safety concerns on the stress test, then they were also excluded and they had to have access to internet or a device for video conferencing at the time. Ok. So once they then um continued to meet criteria and the eligibility for the RCT, they were then randomized to either the physical activity lifestyle intervention, the CHDP or a comparator condition. So in CHDP, they were given a Fitbit that they got to keep like even after the study. So they were handed a Fitbit, they were given an exercise prescription that was tailored to them based on their baseline exercise stress test. So they had an I they had a sense here is what is safe for you to do. So, frequency intensity time, all of that for physical activity. And then they were asked to undergo 8, 20 to 30 minute video conferencing sessions with a trained coach. And I'll talk to you a little bit about what these coaches discussed with patients in just a moment. Now, the comparator was also given a Fitbit. They were also given the tailored exercise uh prescription, but then that was it, they were told go have fun with that wear the acceler or where the Fitbit. Um, and that was it. And then we, uh touched base with them at the end of the study. So what are the coaches talk to the participants about how are we actually instilling this behavior change? So there is, there are several um different health behavior change theories that are out there. We have landed on using the theory of plan behavior for the current study, which ended up serving as kind of the basis of the foundation for the content of what these coaches talk with patients about. So the theory of plant behavior has three different elements that it's comprised of. First are the attitudes towards whatever the a the um the behavior is in this case, obviously, physical activity. And so this is the degree to which a person has a favorable or unfavorable evaluation of the behavior. They also talked about subjective norms regarding physical activity. So it's the perceived social pressure to either perform or not perform that behavior as well as perceived to control, which I think is pretty akin to self efficacy. If any of you are familiar with the term self efficacy, which is the perceived ease or difficulty of performing the behavior based on past experiences and anticipated barriers. So all of those sessions were kind of designed around these elements. And in addition to that I told you, we also gave them a Fitbit and the Fitbit is really also feeding into that perceived control because as patients wear the Fitbit, they're told to monitor their steps, for example, or the number of minutes they spent in active minutes on the Fitbit. And this also gives them a sense of control over. Oh, look if I do certain things, these numbers on my Fitbit change, I changed these numbers because I changed my behavior. In addition, coaches also worked with participants on setting goals that were achievable measurable. And this also builds self efficacy in participants, at least that's a hypothesis over time because here I am, I'm setting these goals and look, I'm accomplishing things. I'm moving forward. I'm setting new goals. So the intervention lasted for 20 weeks. And at the end, we had a post assessment and at the post assessment, we kind of collected the same data via surveys, the exercise stress test as well as the accelerometer. Again, I also just wanted to point out really quickly what the intervention schedule looked like because it's eight sessions over 20 weeks for what, what, what pattern was that in? Well, at first we had the, the first four sessions on a weekly basis and then they started slowly spreading out over the 20 weeks. And once again, here we are trying to uh put our finger on increasing that perceived control. So as the session started spreading out, participants were encouraged more and more to take more ownership and autonomy over the processes that they were engaged in with the coach. OK. So let me share with you um the numbers that we ended up receiving for, for basically what is a pilot study? So for the teams 15 to 18, we ended up having 88 individuals that completed our baseline. Ultimately, 11 declined to proceed to the RCT. We had eight that were unable to be contacted and we only had nine that ended up being ineligible for the RCT. I will just note really quickly because this is also true for the young adults in a post talk analysis. I found that folks who had a fontan procedure were more likely to decline participating in the RCT than folks with other forms of congenital heart disease. They were then randomized which resulted in 31 individuals in our uh active intervention and 29 in our comparison group. And then for the young adults, 19 to 25 we had 74 individuals who completed baseline, five declined, three weren't able to be contacted and 30 ended up being ineligible. And I, and that was a large part due to them actually being physically active, meeting the guidelines of 100 and 50 minutes per week. I'm actually gonna take that as good news. I was happy to see that. Uh We then randomized the folks that we had left 19 in the act of intervention and 17 in the Comparator. So now I'm gonna go through some of the results that we've published for the teens. We haven't yet published the results on the young adults. Um But I will give you a little bit of a spoiler alert at the end before we move on set future directions about that. So just really quickly, just to kind of go over some of the demographics, we had slightly more participants um who were male as opposed to female based on their identification. Um We had uh a majority, vast majority of the participants ended up falling in that moderate category um of CHD complexity. And as I had just alluded to, we had a higher degree of folks who declined, continuing on to the RCT who were Fontan. And we had almost half of the individuals who were in the team group were currently engaged in sports. Now, what I think was kind of interesting about this though despite that. And these are folks who are both in, you know, JV and varsity sports, only 2% of them met federal guidelines of those individuals who are currently engaged in a sport. So I think this also suggests that hitting that 60 minutes on average per day is tough even when these teams are engaged in an active sport. OK. So for gender differences, we um one thing that really kind of emerged to us in the data right away was that these gender differences were certainly there, they, they kind of hit us in the face. And so we saw that there was a difference in um MVP A with females engaging in less MVP A um as compared to males by a decent amount and the same thing for VO two. Um and it's also, you know, from norms, if you look at vo two norms in the in the general population for adolescents, females will be lower than males. Uh But you also wonder how much of that is also driven by the fact that females may also be engaging in less physical activity than males on average. We were also interested in looking at some of those self report measures that were kind of getting at those theory of planned behavior elements because again, this is what we're hypothesizing is kind of the mechanism that drives behavior change, at least that's what we're hoping is happening. And we also noticed that there was some gender differences in one of these elements of the theory of planned behavior. We had two measures of perceived control. We measured self efficacy and we measured barriers to physical activity. And we see that females report lower self efficacy and greater barriers as compared to males. And I don't want to um hit you over the head with a bunch of statistics this morning. It's early. Um And I understand that what I do want to just kind of um show you with this table that came from um uh the, the baseline paper that we published on, on these data is basically that we wanted to see whether or not if we included gender and barriers to physical activity and self efficacy all in the same model, what ended up kind of falling out? Well, we see that even when we're kind of accounting for gender in these models, barriers continues to be a significant uh significantly associated with the outcomes of interest. And this basically suggests that it regardless of one's gender, if you're reporting more barriers, you're likely going to also be engaged in less physical activity. And um also with the case of lower um VO two. So I just wanted to highlight here that we were, we were even trying to see whether or not this varied by gender and it did not and the same pattern emerged for VO two, as I just mentioned, once again, no interaction. OK. So what are the conclusions from baseline? So female gender is a potential risk factor for lower physical activity engagement among teens with CHD. So that's one thing that definitely popped out in the data. And we also um can kind of walk away saying the perceived barriers were independently associated with lower levels of MVP A and do two. So this is certainly something that uh we are interested in tapping into in the next steps of this research. And I also think that this has some implications for downstream consequences over time. So once again, if these folks are less likely to be physically active and that compounds over time, and folks continue not to be very physically active, this could have a downstream consequence on morbidity or mortality via potentially a lower um uh exercise capacity, right? We need longitudinal research to, to, to know that for sure, but that's one potential um outcome of this data. And I really think that this has implications for intervention. Um You know, we're gonna talk about some of the trial uh results here in just a moment. Um And we at the time didn't know that gender was gonna play as much of a role as it seemed to appear here in the baseline data. But certainly in the next steps of this work we're gonna want to consider are females and males gonna necessarily respond the same to the same type of physical activity intervention given that we're seeing these differences. And that's certainly something that we want to note down the road. So let's talk really quickly about the um intervention um outcomes here. So when we first looked at the differences between um our active intervention and our control group, we were disappointed to see that we did not get a uh a statistically significant difference in these groups. It didn't look like any change was occurring and we were really disappointed about that. Obviously, then I had the thought, I was like, gosh, you know, we did have all of these teams that ended up technically making it into the study who again were involved in sports, who had 50 minutes on average per day of MVP A or 55 minutes on average of MVP A per day, which again, all things considered is pretty darn good, but they just, it was a technicality, right? They still made it into the RCT because they were under that 60 minutes. I went back and looked at the literature that has been done in, in the US on physical activity levels. And what we see is that the mean levels of physical activity in the US for teens is around 21 minutes on average per day. So I was like, well, what would happen if we actually kind of siphoned off those folks who were less physically active to start with kind of under that average level of physical activity that's been identified in the literature. And lo and behold, we actually did see an effect of the intervention. So for those individuals who started at baseline with lower levels of MVP A under that 21 minutes, they did improve after undergoing our CHD POWER intervention. So we were pretty excited about that and the effect size was actually quite large that, that SD now, fortunately, we didn't see any differences, the sedentary behavior or exercise capacity. However, I do want to highlight, you can see that there's a significant reduction in our power. We had fewer participants that we were able to look at with this analysis that could be responsible for some of the other null findings. So what are some of the conclusions here targeting teams with lower levels of MVP A? Maybe that is the way to go. Maybe these are the folks that really um think that this is applicable to them that maybe um you know, because they think it's more applicable to them, they really engage more with the intervention one hypothesis. And certainly we're targeting people who are more likely in need of intervention. And CHC Powell did not end up impacting against sedentary behavior or exercise capacity. That was disappointing. But given the smaller sample size, we're not going to draw too much from that at this time. Maybe with a larger sample, we would have more power to detect uh improvement. I also think that these results have the potential for clinical impact, which was exciting to think about. There was a recent paper by Garcia and colleagues that was just published in the British Journal of Sports Medicine. And it's gotten some traction lately because basically what the paper suggests is that even small increases in physical activity over time could have significant reductions in very various types of risk factors including for cardiovascular disease in the general population. So even small improvements may make a difference. Well, if you look at how much our folks improved and again, small sample size, we got to take all of this with a grain of salt. But on average folks in the CHDP condition had improvement of 16 minutes of MVP A on average per day. And if you multiply that across the seven days for the week, maybe that is clinically significant. OK. So that leads us to just thinking about like what are our next steps? Where are we going from here? Well, uh I mentioned that I would kind of foreshadow what we found with the young adults. And thankfully, we actually did find um uh a significant increase in MVP A for those who were engaged in the CHD power condition as compared to the comparator. And we also got a pretty hefty effect side. So we were grateful to see that and that in combination with the data that I've just presented to you that we published on the teams that helped us to actually finally get after four submissions and ro one in order to take this um to the next step and think about um our, our next steps for what this physical activity lifestyle intervention may be. So that brings us to CHG Powell version two. So this is the one that we're currently engaged with. We, we just received the, the notice of award last September and we haven't yet started recruiting, but we're hoping to within the next month. And what I wanted to talk a little bit about is, um you know, where are we going to kind of take this with this new version of CHD Power? How are we moving forward here? Well, first of all, we're gonna try to establish the efficacy of this lifestyle intervention with a larger sample size. Now we're gonna have the power to actually look at some of the things that we really want to look at with the sample. We're also going to use a more rigorous comparative group. So before the comparator group, I would kind of call an enhanced usual care group, right? They, they got it procure, they got a Fitbit that's not common. Most patients don't even get that, but that's all that they received. But what about that connection with the coach? So with uh attention control comparator, we basically have the comparison group. Now also interacting with a health coach, they're just not gonna get the active ingredients that we think that that is responsible for some of this behavior change, which is the theory of plant behavior stuff. So instead they're just gonna get some lifestyle education while interacting with the coach. We're also gonna be powered to now look at change in these mechanisms that we think are responsible for driving the increases in, in moderate to vigorous physical activity. And we're also going to be able to look at durability of the intervention and that's important, right. So I've really been stressing this lifestyle change, the sustainability piece of it. So we're actually gonna follow up with folks 40 weeks and 80 weeks post intervention to see whether or not we're actually able to maintain any effects that we get. We also are going to look at some additional risk factors. So talk about gender. So this time, gender is built into the statistical plan. This is something that we're gonna look at whether or not males and females perform differently as part of the study. And once again, we'll be powered to do that. We're also gonna include a measure of Khoa. I'm not sure if anybody in here is familiar with this, but this is basically like the fear of movement. And we have now data to suggest, you know, in an acquired heart disease as an example that this is something that really could prevent folks from wanting to engage in physical activity. And it hasn't been measured in CHD that I'm aware of that's been published. And so we're gonna try uh to, to take a look at that as well. And we're also going to be giving folks a few um task based measures, assessments of executive function and executive function is basically cognitive abilities that help us organize ourselves, be planful. Uh remember certain things in order to engage in more complex behaviors. And certainly lifestyle change is a complex behavior. And so we also want to officially measure this and see whether or not this may have implications on the outcomes as well. So in summary, um there's gonna, you know, we, we want to look at this empirical examination of these unique risk factors and this is not a one size fits all group. It's a very heterogeneous group as I've been stressing. And so I really think that, you know, being able to explore these unique risk factors is what's gonna drive us forward in CHD research in order to figure out how can we improve outcomes for this population overall? Oops. Oh yes, no, sorry, this is the way I wanted to go. So, in addition to, you know, talking about the risk factors for neurocognitive development, I think there are other things down the road that we want to explore as well, including the impact on emotional distress. For example, we know that folks that have more anxiety and depressive symptoms are less likely to engage in health behaviors that um improve outcomes for themselves. And so this is something that we certainly want to pay uh put an eye towards at some point. And we also can't forget about the impact of social determinants of health and how that has downstream consequences on both risk factors, health behaviors directly, as well as directly health outcomes. So we need informed tailored interventions for this group. And really, I think it's the cross collaboration of the across these disciplines that's really important to maintain. I've been very grateful for my colleagues in cardiology who've been collaborating me with me on this. I've also been collaborating with folks in nursing, uh physical therapy, exercise science. And we really need to continue this cross collaboration in order to enhance this research. So in some, I think that we can build that shelter to weather, that storm of, of acquired heart disease that is certainly looming over us. And I think these are some of the tools that we can use to do that. And I really appreciate your attention this morning. I just wanted to quickly thank I have a host of, of mentors who've been really vital in, in getting this research um completed a great lab that's been working with me over the past six years as well as several um excellent collaborators and just wanted to thank my, my funding sources as well. So thank you for your attention this morning. I appreciate it. Open to question. Yes, problem. Thanks for um two questions. Um Number one, so the more operations you've had the why you are. And then, and then number two, I would argue that phobia is contagious. So, um, you know, there's a lot of uh direction, indirect influence these patients here. Their parents. Oh, I don't want you doing much. I think we're responsible for a lot of their inactivity and we're uncomfortable with that and they come on that underlying that. Um, and I know that a big part of, I certainly think there are some substu we could do in order to help tease those things out. Let me address your first part of the question though. So, you know. Oh, sure. Ok. Ok. Hopefully I can do that. So the first part of the question was about disease burden and whether or not that has implications on some of the outcomes that we saw as well, right? So a number of surgeries, things like that. Um No, we did not see a number of surgeries as being something that played a role. And um, we were also though pretty limited with that because a lot of folks either had one or none surgery basically at that at that point. And a few had, you know, and again, we had a few fontan that some stage procedures, things like that. But a vast majority of the folks in the study either had one or no surgery and the same thing with New York Heart Association class, right? So that's something that has been well established in the literature that has implications for quality of life, other kind of psychosocial outcomes. Vast majority of patients were in New York heart class of one. So we really just didn't have the variability there in order to like, look at some of that further. Do I think that does play a role? Yes, I do. And maybe even, especially once you start entering adulthood and later adulthood, that could be a compounding factor for folks' physical activity over time. But we just didn't see it in, in our group yet. Ok. Second part of the question was about Kinesia phobia and how it's ostensibly contagious and then both cardiologists as well as even patients communicating with one another or parents communicating with patients. This is something you kind of could potentially spread, it might get mad. OK. Um And, and you know, can we kind of tease some of those things out. So, you know, one thing that we did collect some baseline data on and I'll be honest with you, I haven't looked at this in, in great detail. One of the things we wanted to do is we asked patients whether or not they have limitations, any physical activity restrictions. And we asked their parents whether or not independently whether or not they had any activity restrictions. And then we went through the medical chart and indicated yay or nay, whether they had any activity restrictions. I haven't looked, I haven't done that analysis yet, but I'm excited to do it because I think that's kind of getting into at least a perception of whether or not they do. And I think it's a whole other kind of component to even ask the question of like, do they really have activity restrictions? Is it accurate? So even if the cardiologist says yes, and I will say, you know, on average, our, our group has been really, you know, I've been around a while. I think folks trust me. I, I, you know, I think people on average are willing to let me have access to patients every now and then though we will have somebody who will say that no, this patient can't participate and they don't necessarily give a good rationale as to why and, and it, and it kind of is this, oh, they're, they're, they're too complex and it was like, oh, it'd be interesting just to throw them on the treadmill and see what happens, you know, I mean, not to, you know, but like you wonder sometimes you wonder. Um So anyway, I, I think it's a really fascinating question. I want to look more into that and I think it's an excellent point. So thank you for calling I, when you, your intervention in terms of personalization that happened at step one. But ideally for behavioral stuff to personalize based on their response, right? So we have learned week one or week two, they have not met their goal. We know that we're gonna need to make them a little easier and keep people engaged partner they met them. Absolutely. Do you do that? Yeah. You know, and so actually in the treatment manual, what the coaches are instructed to do is that they don't meet a particular goal. They're asked to revisit the goal, don't just abandon it. Let's revisit it and tweak it in order to make that goal more achievable the next time through. And then as they meet those goals, then yes, the coaches are trained to kind of prompt them to kind of push things to the next level and try to say, ok, well, our ultimate goal is to increase moderate to bigger physical activity levels. Where do we, where do we go next from here? Now, patients are allowed to customize which types of goals they want to work on. So throughout the intervention, they are targeting frequency intensity and duration of physical activity and they're allowed to pick at least initially out of like the three. Ok, which one you wanna start with? Which one you want to do? Second, then they have to do the third one and then they get to pick. Ok. Which one do you want to do again? Which one you want? So there's a little bit of like, again customization so that we're getting that buy in and that collaboration with the patient rather than it being very prescriptive, which is what we want to avoid. You also keep some like problem solving sort of training like if I encounter this barrier and here are some things I could do around it. Oh, yes. Yeah. Yeah. So a lot of the perceived control. So the question was, I'm sorry, I'm not repeating the question. The question was, you know, if, if folks end up in barriers, do we actually work with them to overcome those barriers and to troubleshoot the barriers? And absolutely, that's really kind of the foundation of what those coaches are doing. Um, a lot of the barriers that come up, I will say are scheduling. I just don't have the time, I have no time to be physically active. And it's like, yeah, I, I know the feeling, but is that actually true? Do you really not have to? So it's kind of this gentle, challenging with a nonjudgmental stance of trying to get folks to kind of realize, oh, well, if I take the stairs and I park further and I walk my dog for, you know, two times in the day for only 10 minutes at a time, like, how can I start incorporating these things in my daily life? And then do I actually have more control than I thought that I did? Yeah, talk, you know, sounds like a lot of intervention. First part of the video helping approaches. Is there a recipe that they use? Is that reproducible if they like? And then do you think like physical theist will do that or do you need that whole Jamie Jackson kind of stamp on it. Just a psychologist, clinical psychologist only. So doctor question was um first of all, do you to um uh I forgot the standardized. Yes. Is it standardized? Yes. So is the intervention standardized? And then can we can the people who disseminate the intervention be other folks other than people like myself? So, yes, it's standardized in the sense that I have a treatment manual that was developed for the study. Um In the second version of the intervention, we have tweaked it, we've enhanced it. We've kind of figured out what maybe didn't work quite so well the first time or what was awkward for the coaches to deliver. But yes, there is, in fact, a, a manual so somebody offensively could take the manual, open it up and see what the intervention is and your question about the dissemination. It's so funny, you mentioned physical therapist because the majority of my coaches are PT students. And so PT students are just, they have great training and kind of just psychosocial understanding about getting folks to do, engage in health behavior change. They're getting, they're asking folks to increase their physical activity levels all the time and those patients are often resistant because of pain or other things. And so I've actually trained nursing students. PTS, exercise, science folks, like we've kind of had a variety of folks with intervention. So yes, I strongly believe that this could certainly be distributed by a lot of different types of folks in the medical field. Thank you. I think, yeah. So anxiety is so hard measure. Yes, it would be. So the question was, you know, and so anxiety is certainly a problem, particularly in our adult patients. This could be something that could limit their physical activity levels. Do we measure it? Um And, and what have we found? Um we have measured it. So I have used a um cardiac anxiety questionnaire that really gets that kind of physical symptoms. Um you know, again, cardiovascular symptoms that then get kind of translated into anxiety specific. Um And we did not see a change in that. And in fact, in the sample that we had collected the data that I was showing you, they were relatively low in cardiac related anxiety, which surprised me. And this is part of the reason why I wanted to include the Khoa measure this time around because I'm like many of these questions just aren't asking it in a way that's tapping into this population experience. These questions are gonna be more designed around the actual physical activity and that being linked to the cardiovascular system or um symptoms and that kind of anxiety piece of it rather than I'm just afraid of palpitations or I'm just afraid of, you know, whatever um pressure in my chest or, you know, things like that. Um So again, I don't know if it was a sample size issue. I don't know if we just had kind of a, a low level of anxiety in this particular populate, you know, or my sample or, or what happened there, but we didn't see anything yet. But it was a great question because I I that was my hypothesis. So OK, thank you all again for your time and attention this morning. Appreciate it.
