Digital Health Tools (DHT) are portable technologies that participants can use anywhere to capture patient- generated health data (PGHD). This portability creates participant-centric models in research These tools fall into two categories—active and passive. As the name implies, active digital health technologies require participant involvement and can provide an engaging, educational experience that motivates the participant to stay connected with researchers when new research questions arise.
An example of an active engagement DHT is an application that measures cognition, mental health and physical health through a series of tests that the trial participant performs. The Balloon Analogue Risk Task (BART), a test that measures impulsivity and risk aversion, is an example. Conversely, passive DHTs (for example, using wearable devices, like smartwatches or phones, to detect activity and movement to augment clinical data collection) don’t rely as heavily on a participant’s engagement or time commitment in order to continuously share with researchers.
Given the far-reaching nature of researcher cohorts, researchers understandably need to expand clinical trial and research recruitment (and in turn, increase the volume of data captured) in order to achieve their research outcomes. In a pandemic world of limited in-person interaction where traditional site visits are difficult, costly and limited, the role of digital health information technologies and person-generated health tools has become even more essential.
Digital Health Tools promote increased participant applicability through availability of tests
In-person testing availability, or even the use of at-home test kits, have drawbacks—their availability is often limited due to the number of tests available and ultimately determine who is applicable based on a set of screening questions. In any test, researchers should consider prioritization methodologies to determine who gets selected first and how soon the test can be delivered. Digital and mobile health (mhealth) tools can make this process more efficient.
For example, collecting health information through a DHT, such as symptom checking or condition testing, can provide screening techniques that can improve prioritization.
Case in point: During the pandemic, we see many individuals who want a test, but cannot acquire one because they are either not experiencing symptoms or are not part of a high-risk group. As they might still be infected, this presents a public health risk. DHTs can mitigate this by providing these individuals with additional guidance as to when to get tested based on location and proximity to potential risks, thus allowing for a test-early, test-often approach.
Digital health tools reduce the costs of testing by replacing physical or on-site tests
Testing cost can be expensive and cost-prohibitive for both clinical researchers and participants. When considering the size of a cohort, researchers also examine the number of participant tests needed for statistical validity. That means that the cost of offering each test plays a large role in the size of the cohort. In the case of COVID-19, many individuals could not afford the cost of testing (often $100 or higher) unless it was subsidized by health insurance or an employer.
Digital health tools, however, can help to reduce this cost by augmenting or replacing existing physical test tools. Some examples include DHTs that measure respiratory risks.
For example, an in-person six-minute walk test (6MWT) that is commonly used for COPD patients and other hypoxia risks can be replaced by a DHT and mobile phone-based testing of performance measures while using a pulse oximeter to establish both a baseline and, for later, performance degradation that could signal infectious disease.
In addition, combining better symptom screening tools as additional DHTs can provide improved certainty over other respiratory infections like Influenza and ILI(influenza-like illnesses) when symptom screening considers the participant’s location, behavior data and contextual risk indicators like the current spread of the illness in the participant’s vicinity.
Digital health tools increase accessibility for participant inclusion
Researchers also typically consider whether the participant will how up for the site visit or complete the test as scheduled (depending on demographics, income and housing reach, it can be very difficult for some participants to travel to a site or even to mail test results).
Utilizing digital health tools helps to bridge these gaps by allowing an “anytime-anywhere” approach to access. Because DHTs are always accessible on a mobile phone, it is more likely that participants can check-in wherever is convenient. Whether they are on vacation, at home, or out and about.
In closing, there are many digital health tools on the market today that you can incorporate into your clinical data management and research workflows for participant contributions. These DHTs can replace many in-person or physical tests and help to reduce costs, increase accessibility and improve the prioritization of test delivery. If you are unsure about which tools to use, or how to incorporate them into your workflow, consult a trusted digital technology partner with experience in decentralized clinical trials (DCT) and DHTs.
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