The top 3 barriers to Alzheimer’s disease patient recruitment, and how to overcome them
Like every indication, Alzheimer’ disease has its own set of unique barriers to patient recruitment for clinical trials. In addition to the typical ones that are often mentioned in patient recruitment literature, such as inclusive language, patient-centric materials, and outreach channel selection, there are 3 barriers we think are too often ignored by organizers of clinical trials.
Having supported 10+ international Alzheimer’s disease clinical trials, from early to late stage conditions, we have gained a thorough understanding of the barriers different Alzheimer’s patient populations face and have the knowledge of how to overcome these using new targeting and outreach techniques, developing more educational study materials, and additional services.
In this blog, we share the 3 biggest barriers to recruiting patients with Alzheimer’s disease and how we overcome them. These barriers include:
- The dependency of Alzheimer’s patients on caregivers
- Hesitance to stop taking known / tested medication
- The digital literacy of mature patients
1. The dependency on caregivers to participate in clinical trials
How caregiver dependency impacts trial participation
Research has shown that patients with dementia are less likely to participate in clinical trial research if their primary caregiver is not a spouse. The main issue here is not care or will, it is logistical. Often patients with Alzheimer’s disease who don’t require continuous support, are routinely cared for by family and friends.
From Clariness’ experience in Alzheimer’s disease clinical trial recruitment, we know that a number of eligible patients are unable to participate in a study due to transport issues. Patients facing these issues are typically those with caregivers who do not live close to the patient and are tied to other obligations.
How to overcome the caregiver dependency barrier
Decentralized clinical trials
Whether fully virtual or hybrid, decentralized clinical trials (DCT) reduce the number of visits to the study center a patient has to make for in-person consultations, and thus, offer a solution to the dependency on others for transportation to and from sites.
Typically the majority of Alzheimer’s patients are elderly, and so there are often concerns of digital literacy with this patient population, however Clariness has experience in delivering fully virtual dementia trials which have proven successful in implementation and recruitment, using educational materials that support digital participation, but this will be covered later in the blog. Clariness is able to support the study design of DCT should you require help in decentralizing your upcoming or current clinical trial, just contact us.
Valet service – transporting patients to sites
Fully virtual trials are not an option for some patient populations, such as those requiring positron emission tomography (PET) scans to confirm or monitor the severity of a patient’s Alzheimer’s disease. PET scans require the patient to visit the site in-person, which again places a dependency on a caregiver to transport the patient to and from sites at regular intervals.
To address this, Clariness has developed a valet service which coordinates the logistics and transport of patients, which removes the need for a caregiver to transport the patient. This service removes the burden on caregivers and the site as everything is coordinated by Clariness.
2. Hesitance to stop taking approved, prescribed medication
How medication impacts trial participation
Patients diagnosed with Alzheimer’s disease, depending on the severity of their condition, will be prescribed inhibitors and/or memantine. Typical drugs prescribed for this including donepezil, rivastigmine, and galantamine, have reportedly temporary benefits but, ultimately the condition in most cases will gradually worsen. Despite this, patients who take these medications still have hesitancy towards trying new, not yet approved, medication. Indeed, despite the downsides, many patients logically prefer the medication they know and are used to instead of medication they know little about.
If sponsors and sites put themselves into the shoes of their patients, this reluctance to trial new drugs is understandable. Approved drugs can offer a 6-12 month pause, or even an improvement to the patient’s condition, and this window can be life-changing for the patient.
How to overcome medication dependency barriers
While this issue is sensitive to address, Clariness has identified several approaches that can overcome this barrier:
Patient education and patient-centric materials
Patients who are educated on the short-term effects of well-known medications are sometimes more likely to seek something that can potentially offer longer-lasting improvements. This should be addressed in the discovery stage of the patient’s journey, as this is known to impact the early stages when patients consider to participate in a clinical trial .
Patient-centric study materials are the key to educating the patient of these short-term effects in an empathetic manner, and using patient friendly terminology. Too often clinical trial materials are loaded with medical jargon that can discourage patients from reading more.
At Clariness, we’ve surveyed and held focus groups with thousands of patients with Alzheimer’s disease across the globe, to understand the impact of different terminology and ensure we deliver this sensitive information in the most patient friendly way possible, which is one of the reasons our study websites and materials lead to higher referral rates.
Advocating patient altruism
A significant incentive for clinical trial participation is altruism, the principle and moral practice of concern for the well-being of others. Advocating this driver and highlighting that participation will benefit current and future patients with a similar condition can sometimes be powerful enough to convince a patient to try a new drug and enroll in a clinical trial.
The COVID-19 pandemic brought patient altruism in the world spotlight, showcasing how immediately beneficial clinical trials can be for the wider population. In a recent COVID-19 patient recruitment campaign run by Clariness, a patient expressly encouraged other potential patients to follow their lead. Below you can see this patient’s comment and they are not alone in advocating altruism among the world of patients:
Figure 1: A comment from a patient on one of Clariness’ COVID-19 social media advertisements
At Clariness, we document all patient feedback and use it to develop new campaigns and often share the patient’s voice with other potential patients, this is a powerful tool in convincing clinical trial participation.
3. The digital literacy of patients
How digital literacy impacts Alzheimer’s disease clinical trials
The internet and other digital channels offer powerful ways to target, reach and engage patients on a global scale, breaking down geographical barriers in patient recruitment unlike seen prior to their usage. Furthermore, it allows even truly, multinational, global campaigns still be informed by local expertise and group specific outreach materials. Unsurprisingly though, a recent survey highlighted that many older patients are more reluctant to use digital devices such as smartphones, computers, and channels such as the internet and social media. This is due to a variety of reasons, including fear of making errors, and broader worries about their social responsibilities.
In the UK, nearly half of individuals who use the internet say they needed assistance setting-up or using a new digital gadget. Further, one third of persons aged 65 and older have never accessed the internet, and half lack access at home. Even in San Francisco, which is home to some of the world’s largest tech giants such as Twitter, Facebook, and Google, 40% of older individuals lack basic digital literacy skills, and more than half of these individuals do not use the internet at all.
This demonstrates that older individuals are less skilled when it comes to utilizing online tools and that they need support when it comes to using digital technologies. This lower level of digital literacy, especially for the typical target age of patients with Alzheimer’s disease, means that it requires knowledge and data-driven methods to reach patients and let them interact with Alzheimer patient recruitment campaigns. Even if they do engage, they still may struggle with proceeding through the online patient journey, complete the pre-screener, . Let alone, find a research center in their proximity, contact the research staff. This means that non-patient centric digital patient recruitment campaigns for Alzheimer disease simply often fail as patients don’t complete the screener or abandon the journey through frustration or fear of errors. It also shows how important it is to choose a patient recruitment partner with a data-driven understanding of the local patient population and experience with global outreach campaigns for dementia studies, like Clariness.
How to overcome digital literacy barriers
Clariness has a long history of successfully reaching and recruiting patients with Alzheimer’s disease through online channels, and has overcome this barrier through 3 intertwined and data and experience driven approaches.
1. Use the right digital channels
It’s important to understand the changing demographics of online channels, especially social media channels. Trends and innovation mean that social media users migrate between channels, typically with younger audiences moving to newer channels. More so, social media is used in often very distinctive ways by different groups, making it essential for outreach campaigns to build on an in-depth understanding of the study-specific patient population. The likelihood of engaging a mature patient with Alzheimer’s disease on TikTok is a lot less likely than engaging them through more traditional online channels such as Facebook or display advertising on websites with older audience profiles. And even on Facebook, it is not as simply as just reaching out to people who have an interest in Alzheimer related pages.
Furthermore, by understanding the audience demographics and behaviors of various online channels, recruitment specialists like Clariness have insight into which channels will prove more effective in recruiting different patient populations. In previous online Alzheimer’s disease patient recruitment campaigns, we for example placed advertisements on websites known to provide mental stimulation, such as online puzzles and sudoku sites.
Knowing that patients with Alzheimer’s disease are more likely to visit sites that can potentially enhance or maintain cognitive function means we align our advertising with the channels our target patient population uses.
2. Target both patients and caregivers
While patients with Alzheimer’s disease may have a lower level of digital literacy, depending on the stage of the disease, often they are dependent on caregivers whom typically have a higher digital literacy level. For this reason it is important to adjust outreach campaigns to target both patients and caregivers. At Clariness, we do this by creating online advertisements that also speak to potential caregivers and by allowing caregivers to fill in the pre-screener. This way, caregivers can complete the study application journey behalf of the patient, or support the patient throughout each step of the process.
When developing a campaign that will also target caregivers, Clariness will adapt its materials and channel usage accordingly, providing materials that explain the role of the caregiver and educate on the process and potential benefits of such a clinical trial. Clariness has completed surveys with caregivers to gain an understanding of their needs and wishes. This way, our Study Feasibility insights for Alzheimer’s disease clinical trials are able to estimate if organizers can successfully randomize patients that were registered by caregivers.
3. Deliver a patient-centric, user-friendly experience
Understanding potential pain points within the patient’s study application journey as a result of lower digital literacy, Clariness has developed user-friendly digital steps, included more language options and implemented simpler functionality to cater for these patients.
Clariness’ patient-centric clinical trial matching platform, ClinLife®, was built in direct collaboration with patients and is continuously optimized to provide a patient-centric access to clinical trials. ClinLife® is available in over 35 languages, and uses patient-centric language developed through focus groups with thousands of patients, including patients and caregivers of Alzheimer’s disease.
In conclusion, successful recruitment is built upon patient understanding
A deep understanding of the target patient population is the key to overcoming all of the barriers described in this blog. It allows for a patient-centric digital outreach approach to the study-specific patient population and their caregivers. By understanding the common hesitancies/worries/misconceptions that stops Alzheimer patients from participating in clinical trials as well as their caregivers typical digital behaviors and information channel usage, Clariness’ has successfully supported over 30+ dementia clinical trials.
By partnering with Clariness, you get access to 17 years’ of experience with removing barriers to patient recruitment for dementia trials.
To find out more, or to discuss your upcoming or underway Alzheimer’s clinical trials, contact us now.
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