The uMotif Care Cluster Solution: Capturing Quality Data from Participants & Their Caregivers

By: Florence Mowlem, PhD, Chief Scientific Officer, uMotif 

uMotif’s Care Cluster solution supports the needs of clinical research studies collecting data from multiple reporters, facilitating the capture of high-quality, attributable data, while providing a user-centered experience.  

We sat down with our Chief Scientific Officer Dr. Flo Mowlem to discuss the problems Care Cluster solves and the opportunities it creates for participants, caregivers, and trial sponsors in their data collection.  

Tell us about the functionality of uMotif’s Care Cluster Solution. 

uMotif’s Care Cluster functionality enables sponsors to set up their data capture to support multiple people reporting on a participant, with the knowledge that they will know exactly who is completing the data entry. 

A Care Cluster is the group of people who sit around a participant and can also include the participant themselves. It’s also important to say that this does not include healthcare professionals. 

Can you provide some examples of when we would see the Care Cluster solution used and what challenges in data capture it is addressing? 

here are two primary examples where we would see this approach used. 

The first is in pediatric trials where we know there is not always a single primary caregiver with whom the child spends all of their time, and so we want to be able to support reporting from multiple caregivers for that participant, while ensuring that we also know exactly who is the one reporting.  

It can also be that a study design requires both the caregiver (observer-reported outcome/ObsRO) and the participant (patient-reported outcome/PRO) to report, or we want to get each of their potentially differing perspectives on the same concept. And in some scenarios, the child may be able to self-report about most aspects of their health and functioning but not about other elements, such as medication administration which would be supervised by the caregiver. 

The second example is in trials with individuals who have cognitive dysfunction, for indications such as Alzheimer’s disease and dementia where it can be common that the participant is not able to self-report, or they are, but it’s important to have the perspective of both the caregiver and the participant. Again, as we see with pediatric trials, it would be remiss to assume that there is only a primary caregiver, and so it may be the case that there needs to be multiple caregivers who can report on the participant’s functioning. 

We also see other therapeutic areas such as Parkinson’s disease where some of the common clinical outcome assessments include reports from both the participant and the caregiver. 

But isn’t this already happening? Why are we only just starting to hear more about it now? 

Yes, I think it’s highly likely that more than a single caregiver has already been contributing to the data within a trial without clear attributability of this. However, traditionally we have captured data on paper, so there wasn’t the ability to track this in the way that we can with electronic solutions. Electronic solutions now provide us the means to reliably capture attributability, but it can be sort of a double-edged sword because we also know that it is not ideal to have multiple people responding due to known variability between raters, as discussed by Estelle Haenel, Kayentis, and Florence Mowlem, uMotif, in the Data Collection in Clinical Trials with Multiple Caregivers blog from Applied Clinical Trials. However, you could argue that if we have already had multiple caregivers reporting, the noise that it adds to the data hasn’t been a massive issue. It’s just now that we have an electronic system, we have a way of knowing about it. 

We also have advanced statistical techniques that can deal with a lot of variability that arises. We all know how critical the data is, but we cannot ignore the reality of the lives that participants – indeed humans – are living. The key is knowing and planning for this so that it can be incorporated into statistical analyses plans.  

Ultimately, that’s why uMotif developed this Care Cluster functionality. It would be naïve to pretend this isn’t something that is happening, and if we can plan for it from the outset we have the best chance of more seamlessly integrating data collection into the lives of trial participants and their core Care Cluster, and finding an appropriate way of way to account for it in the analyses of the trial data. 

In your role as Chief Scientific Officer, how do you support clients in their decision to adopt the Care Cluster approach? 

In my role in general, I am always very clear that the ultimate decision on a study design approach lies with the sponsor, but that I will present my recommendations based on my experience in the field and supporting similar trials.  

I will have a very transparent and open discussion with the customer about both the potential risks and the benefits so that they can make an informed decision about whether to adopt this Care Cluster functionality and if it is right for their specific study design. 

That is to say that, with all technology, just because we can do it doesn’t always mean we should, and it’s about understanding the pros and cons of, and the impact that technology will have on data collection in clinical trials.  

At uMotif I would say that that’s what we really care about, having both the technology expertise and abilities, paired with the scientific and regulatory expertise, so that we can take a tailored approach based on what is required for a given customer’s clinical trial.