how behavioural science can improve clinical trials and empower patient health
6 minute read
in medical treatment for home use or in clinical trials, it's important to understand what to expect and to track the outcomes with a tool. "invariably, most people are really bad at remembering stuff."
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preventive healthcare starts with the individual.
dr. simon bacon, a leading behaviour scientist in canada, wears a smartwatch that tracks his physical activity and his sleep patterns. he’s serious about his own health and the health of canadians in general. how we take care of ourselves through healthy physical and mental behaviours is the foundation for how we grow and age, he says.
part of his job as a researcher and co-director of the montreal behavioural medicine centre lab at concordia university is to develop personalized interventions to help change high-risk behaviours so that people don’t end up with chronic diseases like obesity, cardiovascular disease and respiratory disease—or if they have them, they can slow the progression and improve their quality of life.
just consider that cardiovascular diseases are the second leading cause of death in canada, accounting for around 17.7 percent of all deaths in 2023. estimates noted that around 76,962 people died that year from heart disease, essential hypertension and hypertensive renal disease, cerebrovascular diseases, atherosclerosis and other diseases related to the circulatory system. we also know from the heart and stroke foundation of canada that nearly 80 percent of premature heart disease and stroke cases can be prevented by avoiding known risk factors (smoking, consuming too many processed foods) and living a healthy, active lifestyle.
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empowering people to change their behaviours
“probably the greatest challenge we have facing us is helping people, being able to empower people to change their behaviours in a positive way. and we’re starting to get to the point where we have really good tools, we have really good understanding, so we have the real capacity to do that,” bacon says.
the next generation of researchers who are populating academia, industry and government agencies is strong. “i feel like we’re really on a cusp of something that’s really impressive. and that ultimately, if we can realize that potential, will not only put canada at the forefront of these things, but also invariably help canadians in a really specific, significant way.”
the big outcomes he’s supporting are ones that we all need to pay attention to, including physical activity, diet, weight management and medication adherence. one of the key interventions for this is self-monitoring tools. we don’t want to fall off our healthy eating plan, for example, and return to fast-food lunches just because we’re not sure it’s doing us any good.
“if we’re starting a new behaviour, we have to understand what we’re doing beforehand, what we’re doing now and how it’s changing. and those things become really important because it actually helps us to start tracking the outcomes that are important to us with the behaviours we’re engaging in. and invariably, most people are really bad at remembering stuff,” he says.
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bacon is also the founder and chair of the canadian behavioural intervention and trials network, a training platform for clinical trials, dedicated to helping health researchers who spearhead and run clinical trials to appropriately develop and test behaviour change interventions. the network has also created training to lay the groundwork for putting these interventions into healthcare practice. he spoke at the clinical trials ontario conference to share his perspective on improving recruitment and participation in clinical trials, which has a lot to do with behaviour science: what do participants want from the clinical trial? what happens if they miss following the medication or therapy protocols one day? do they go ahead and double up the next day? and if something may prove challenging during the trial, explaining this beforehand to prospective participants during the recruitment process can help prepare them so they won’t leave the trials. retention is an issue.
how behaviour science can improve clinical trials
all of these factors can influence the clinical trial as it’s running, as well as the data on the efficacy of the therapy, device or medication.
“the challenge is for those people who are recruiting and doing all that initial work, is don’t assume that this person is like gung-ho,” he explains in the interview with healthing after the conference. “sometimes, yes, someone is joining the clinical trial for the greater good, but sometimes they’re joining because their physician recommended it and they don’t want to upset their physician.”
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there’s also a need for truly informed consent for participants so they will understand both the process and the expectations of researchers for adherence and outcomes.
“if you just want to try and get people into the study, sometimes you’re not quite as detailed in the explanations of the project. sometimes you don’t necessarily want to spend the time because you’ve got four other people that you need to get to, to go through the nuances to validate. but real informed consent means that people really understand, and it actually creates the right expectation.”
people’s expectations throughout that process and during a clinical trial are important, given how the human mind connects with the body, he says. bacon spent a lot of his early career working in hypertension, or high blood pressure, studying behaviour change interventions and looking at the pharmacological literature.
“blood pressure is very heavily influenced by our mind. there’s many mind-body links and connections. so just being enrolled in a trial will give you an advantage of dropping your blood pressure by about 5 to 10 mm of mercury.” the average placebo effect is as significant as most medications that are used in real-world settings. as it turns out, human behaviour is as complex as human health.
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he comes back to his thoughts on self-monitoring personal progress as a key motivation to adopt new behaviours.
if you don’t find a meaningful way to record that information, you don’t have the ability to go back and realize you had a good week, and from that, look at what you did with your behaviour that might account for that, he notes.
“you can reflect on the week before, where you did a little less of something, where the result wasn’t great. so i’m adding more, and it’s getting better, and that creates that nice reinforcing element. it could be a journal, it could be an online tool, it could be a note or it could be automatic. i’ve got my accelerometer, and i check it to look at my physical activity and my sleep patterns, right? it’s a nice way to validate. without me having to do anything, it’s even better. so, that self-monitoring piece is a really key element.”
ai and digital health solutions prevent lapses
with ai front and centre in most sectors, another role bacon serves is research chair in artificial intelligence and digital health to develop automatic emotion recognition algorithms to help health programs better personalize program content. the aim is to address ambivalence, a hurdle for people to stay committed to health behaviour change interventions.
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of course, change can be hard for people, so giving up on those new year’s resolutions by february isn’t all that surprising.
“everybody stumbles no matter what you’re doing. no one does everything perfectly all the time. for the things in our general life that we do on a regular basis, we have worked this all out informally and we know how to recover from it. but when something new comes along that’s not in your typical wheelhouse and you falter, if you don’t have tools right there and then, it’s called a lapse. everyone has a lapse. and the trick is empowering people to be able to overcome the lapse without becoming a relapse or a complete break in the behaviour.”
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