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MS Masterclass: Selected Short talk: Preliminary efficacy and feasibility of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COBMS) | Dr Sinead Hynes National University of Ireland, Galway, Ireland

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Summary

This on-demand teaching session provides medical professionals with an overview of the feasibility trial recently completed on cognitive rehabilitation for people with MS. It covers the prevalence of cognitive symptoms in MS, the focus of the intervention, data collection, fidelity of treatment, and preliminary efficacy of the program. Additionally, it discusses the feedback received from participants and occupational therapists, as well as planned progression to a definitive trial. This session presents a unique opportunity to learn how to better support people with MS through a cognitive rehabilitation program.

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Learning objectives

Learning Objectives:

  1. Understand the prevalence of cognitive difficulties in MS
  2. Describe the intervention goals of the COBM-S program
  3. List the components of the COBM-S program and the evidence from a Cochran review that supported it
  4. Recognize the roles of Patient and Public Involvement (PPI) implemented to design the study
  5. Explain the findings from the feasibility and preliminary efficacy trails for the COBM-S program.
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Computer generated transcript

Warning!
The following transcript was generated automatically from the content and has not been checked or corrected manually.

Hi, everyone. Um, So I'm from the newly rebranded university of Go away. Um, and I'm going to give just a quick overview of a feasibility trial that we have just very recently completed, uh, looking at cognitive rehabilitation, Um, so just, I suppose, by means of a quick overview to give some background to cognitive difficulties and the impact on people with M s. So it's estimated that the figures kind of variable between about 40 and 65% of people with M s um, experience cognitive difficulties, so these can vary as well. So some people can experience quite significant cognitive difficulties Where, uh, the cognition cognition is kind of their main symptom. Other people have more kind of mild, um, mild, uh, difficulties with cognition. Um, but it's really found to be a really significant from the patient's perspective, For example, it it's, uh, most likely to be linked with people being unemployed. It also correlates with things like fatigue, depression, um, ability to maintain employment. As I said so people be coming unemployed people having to reduce hours at work. People may be working longer hours in order to to try to compensate for some of the difficulties that they had before. Um, people, uh, aren't engaging with social activities as much as they were before. So maybe difficulty maintaining conversations are keeping up with with things, activities with friends, managing homes or things like maybe doing homework with Children or just maintaining finances and things like that, um, and other self care activities. So it really has a lot of knock on effects for, uh, for patients that we work with. So there is, um, this area of cognitive rehabilitation is an area that's grown a lot in the last few years. Um, and the evidence is is still growing. So there's there's good potential there. We still don't know for sure how effective cognitive rehabilitation is. Um, there's a nice Cochran review that came out last year from Russia and dysentery in his group in Nottingham, although he's just moved to Norway. Um, but they looked at memory rehabilitation in M s and found that there's potential short term effects for memory rehabilitation for people with M s. But a lot more kind of high quality randomized control trials need to be done. We need to see how effective it is, what the active ingredients are who cognitive rehabilitation works for, uh, and that kind of thing. So the intervention that we're looking at here is the cob m s or the cognitive occupation based program for people with multiple sclerosis. So the idea with this program is that we really wanted to take kind of an occupational focus with this. So we were looking at targeting occupations by occupations. I mean, the things that people do in there every day, so that could be self care. Things like looking after yourself, getting up, getting dressed in the morning, going to work. Um, anything like that. We're talking about leisure activities, Um, and it's run by an occupational therapist. So it's slightly different to maybe some of the other more psychology focused, um, interventions. You see, uh, the intervention itself is based on cognitive rehabilitation theory, occupational therapy theory, behavioral change and a number of other, uh, theoretical background. Uh, so there's a mixture of individual group sessions. We got eight sessions. Um, there's the person with M s as an individual session with an occupational therapist at the beginning and at the end. And then there's six group sessions. Um, and the focus was really on managing employment, managing daily life, community engagement and getting out and getting out there into the community. Um, and we use things like routines that people are doing anyway compensation strategies, um, and then kind of streaming the demands of people's lives through the program. Um, and the idea is that people will be able to manage better in their everyday life. Um, and that they can kind of compensate or find ways to manage their difficulties due to their cognition. So we we we looked at this program looking at the initial feasibility through a single blind cluster randomized controlled trial of this program. So we had two groups. We had one group that completed the carbon, this program and then we had a weightless control group. So, um, the people in the control group were provided with it with the intervention at the very end. Um, once we have finished all data collection, the program itself was one by occupational therapist within the Health service of executive in the Republic of Ireland. They were occupational therapist who were working clinically. They were recruited and trained, so they were delivering this on top of their kind of clinical caseloads. So for some people, they were doing this in the evenings and weekends. People that were very keen to be involved. Um, others, uh, they had some kind of time that was allocated them from their managers. We weren't able to pay any of the therapists. Unfortunately, who took part in this? So a lot of kind of goodwill from the occupational therapy community community. Um, and the same with this trial is we're looking really at feasibility outcome. So how feasible was the program was accepted by the occupational therapist and that people with ms um and then we were looking at some preliminary efficacy. Um, much. This data is still under analysis at the moment, though, Um, And then just to note, this trial was initially set up as an in person trial. So we were going to collect all of our data in person. Um, either in community venues on people's homes, we did start doing that, and we we gathered a good number of a good amount of baseline data from participants. Um, but then we have to switch to online. So we collected all of our data. Either we collected remotely so either online or by post. And, um, the intervention itself was then delivered, Um uh, online as well. So this is there's a lot of, um, we we use a lot of patient involved in public and patient involvement. Um, at this point, particularly when we were trying to do the changes between online, uh, and figure out kind of what we needed to change what worked from the patient's perspective. So these are just some of the objectives that we were looking at. Um, we wanted to look at the outcome measures and the procedures. Uh, we wanted to look at some of the preliminary efficacy. As I said, we're also interested in, um, some of the other feasibility and acceptability. We were looking at fidelity of treatment. We wanted to look at some of the barriers and facilitators. So we did this in a number of different ways that don't have time in in my eight minutes to go into it all today. So I'm just giving you a very, very quick kind of overview of what we did. We also completed five studies within a trial that looked at barriers. Facilitators looked at that area of um, online data collection. Um, and we looked at some other methodological areas that were of interest for, um, for our trial. Um, and then the overall kind of aim was to look at whether it was appropriate or not to progress to, uh, finish the trial. Um, So as I said that the analysis is still ongoing, there's actually a type of there that should that should say intercept. And this should be, um, the weightless control group. So we looked at the This is a mixed in your model where we were looking at the intercept at the level of the therapist. So it was important for us to look at, uh was the effect or two allowing our analysis the effect of the therapist We had about 20 occupational therapist that we're delivering the program. Um, and as you can imagine, it's quite a difference there in terms of the, um, experience that people had the occupational therapist had. And that's how people engaged a group. So we That's why we factor that into the analysis as well. Um, our primary outcome measure was a goal attainment scaling. So we didn't have a We have a secondary outcomes in cognition, quality of life, mood areas like that. But we really wanted to keep that focus on occupation. So that's why we chose the goal attainment. Scaling as a primary outcome, we collected data base line, post intervention, which was about 9 10 weeks, Um, 12 weeks and at six months. And, um, our preliminary analysis does show a significant effect on the on the gold attainment. Squealing again? You know, that wasn't the primary aim our premiums to look at the feasibility, um, outcomes. We have a base 110 participants randomized, and we maintained most of those at six months. I think we our final number at six months follow up was 97 participants which, considering all of the impacts, Oncovin and everything were quite happy with, um and the analysis is ongoing. So look at looking at some of the acceptability and feasibility. The fidelity to the intervention was very high for the occupational therapists. Um, we also did some, um uh, focus groups of occupational therapist. Looking at some of the buyers and facilitators in practice. These are just some quotes from, um, participants with M s who participated in the program won't read them all out. I might just read the first one. Um, I found the program itself is valuable, and the zoom format probably suited me at the time, as I was suffering very badly from chronic fatigue and not having to travel up and down to a specific place. Given that I live in a rural setting, as most people do, the same format actually suited me down to the ground. Um, as I'm a chatter. So I did miss the interaction, so there's a double edged sword on that one. But the fact that I didn't have to travel with chronic fatigue meant an awful lot to me at the time. So that's the feedback that we got a lot from people was how much more accessible the program was because it was online. Um, that said, some people were saying that they did miss that group interaction, and we tried to mimic that a bit with the online, um, format. But it's it's difficult, and it's not quite the same. And it's something that we're working on, Um, for the next stage, kind of how we how we can kind of manage that, Um, so just I supposed to wrap up? Um, we're happy that the program itself and the trial protocols were feasible. Um, we made some are making some minor changes based on patient public involvement. Uh, feedback from our participants. Feedback from the occupational therapist who took part. Um, the preliminary efficacy appears to be promising. Um, with with regards to our primary outcome measure, the qualitative data that we gathered is also accepted by both participants and the occupational therapist, which is very important because we also did a survey. National survey is part of this work where we found that the occupational therapist do you seem to be the people that work with people with m s with cognitive difficulties the most. So it's very important for us that the O ts were also happy to, uh, we're happy with the program. Um, and we we have met her progression criteria. Um, although our final trials steering committee is at the end of this week, so that has to be confirmed. Um, and we're hoping at this stage we're putting in some funding for a definitive trial of this program. So just going to say thanks to our team and to acknowledge help of our public and patient advisory group and M S Ireland and the Health Research Board for funding for this trial. Thank you. Mhm. Thank you. That was very interesting. Questions from the room. Any questions online today? So mhm. Pull. I'm really interested because I can see that you've got opposing forces going on here. You're talking about the cognition is very, very much affected by social interaction. And then obviously you're talking about the impact of having, you know, rolling out this sort of a preliminary trial during the, you know, pre Covert and Provera. So how you kind of iron out any sort of changes, like both with the control weightless group and your court group? Did they both change in any way or, you know, obviously, uh, the participants. He said It's great when I take that I don't have trouble. You know, that's a big advantage. But then, if there is a significant effect on cognition of not having a social interaction, is there anything that you can do to kind of iron out what happens? Or do you have to do a post coated sort of analysis again? I suppose we we knew that the the impact of cove it would be, Well, it would be significant for everybody, but it could be more significant for people with them. As a lot of people in our cohort, we're living on their own or we're just living with one person. Um, there are also isolating for longer. Um, so when other people, maybe we're starting to come out into the community more, um, we found that our participants weren't doing that, at least not as as early as kind of the general population. Um, what we did have to do from the trial perspective is we have to to, um, So we have gathered based on that on people, and we had to We had to gather that that again, um, to have a proper comparison, I suppose. Yeah. Yeah. So we have a new baseline. Um, and that's why we were able to look at kind of the differences between the data collected in person and the data collected online as part of one of our subsidies. Um, but yeah, the, uh for for some people, they're having been part of that group online. That was kind of one of the social interactions that they had during the week. Um and I suppose with our weight loss control group, they didn't have that because they were still in the weight loss control. So what we had kind of seen as our kind of usual care, um, was different than it would have been, Um, if we weren't in a pandemic situation. Difficult. Very upset. Thank you. Thank you. Just going forward. Would you Are you going back to the person and going for a project? A. Uh yeah, that's that's a good question. So we we've just put together an application, and we're looking at both, So we're gonna We're gonna look at usual care. We're going to look in on online version and, uh, in person delivered version. Um, and that's what we're trying to work a bit more and trying to match that online experience a bit more with what an in person experience would be like. Thank you.