Can digital health reduce the treatment burden on patients?

Comprehensive neuropsychological testing typically takes hours to complete, which can be mentally and physically burdensome for patients. Furthermore, the travel required and overall time-commitment to undergo these procedures within a clinic can result in decreased study compliance. Together these factors can confound conclusions concerning treatment efficacy. Here we will discuss how digital health can reduce these burdens when implementing therapeutic interventions to improve patient outcomes.

Four reasons to use digital health in your clinical trials:

1. Improve the signal-to-noise ratio

2. Measure behaviour more accurately

3. Give meaning to daily activities

4. Reduce the treatment burden on patients

Comprehensive neuropsychological testing: rich data or fatigued participants?

Comprehensive neuropsychological testing batteries are conducted in order to establish a rich behavioural dataset from which the therapeutic effects of a compound can be derived. However, the collection of such data presents a substantial time-commitment for patients, caregivers and researchers. Therefore the benefits of comprehensive neuropsychological testing must be carefully balanced with the impact of such lengthy procedures upon a patient’s well-being and compliance.

The burden of lengthy cognitive testing can also be exacerbated when a full regime of cognitive tests are typically coupled with other invasive procedures, such as extracting biological samples. The consequence can be severe mental and physical fatigue, especially in patient populations who have cognitive deficits as part of their defining symptomology. Furthermore, patient fatigue and stress can dilute the sensitivity of any performance-based measures, damaging the overall integrity of the trial.

One typical method of attempting to reduce these factors is to increase the duration between assessments, sometimes on the order of a few months between each subsequent testing session. However, this approach is not ideal since it will substantially increase the overall duration of a drug trial study and, importantly, will also extend the time it takes to discover if a medication is efficacious for the patient.

All of the factors described here, and in previous posts within this series, elucidate a growing diaspora between therapeutic interventions and patients’ control over the healthcare they feel will beneficially impact their personal needs. Patients and caregivers often report feelings of not being in charge of their own medical treatment (1,2) where the perceived link between the relevance of medical tests to their own health and wellbeing are disjointed in time and applicability.

What is the cost of comprehensive neuropsychological testing?

Although in theory conducting comprehensive neuropsychological testing establishes a more complete profile of a clinical population’s impairment, this approach can result in unnecessary increases in patient burden and reduce the sensitivity of outcome measures by:

Reducing the number of longitudinal time points for data collection
Unnecessarily increasing study duration and expenditures
Reducing timely detection of medication non-responsiveness
Adversely affecting patient compliance and drug adherence
Patient fatigue minimising sensitivity to detecting positive drug effect

What are the benefits of patient-centred virtual research?

In contrast, there are several benefits associated with patient-centred virtual research, including:

High frequency brief assessments can increase patient compliance and reduce the detrimental effects of physical and mental fatigue commonly reported during full neuropsychological batteries.
Remote and ‘at-home’ cognitive testing platforms reduce the burden on patients and care-givers in regards to travel and scheduling, as well as boosting inclusivity for patients who do not have the one-on-one care support required to participate in research.
Allows the patient, and clinicians, access to their EMA relevant medical information, sharing personalised insights that can directly impact their own lives and treatment regime.

Are high-frequency clinical assessments practical in clinical trials?

With the advent of digital health, high-frequency clinical assessments have become a viable addition, and in some cases alternative, to low-frequency, face-to-face cognitive assessments.

In both outpatient clinical therapeutics and later phase drug trials, this technology has allowed researchers and clinicians to remotely monitor patients symptoms via wearable devices and smartphones that can be programmed to remotely administer frequent, brief assessments of cognition and mood.

This high-frequency trial design was found to be highly effective in a recent study conducted by Cambridge Cognition and Takeda. The study used the Apple Watch to deliver daily assessments of mood and cognition for patients with major depressive disorder. The excellent compliance rates are visualised in the figure below.

Summary

The recent upward trajectory of digital capabilities over the last decade has fostered a new field of clinical opportunities in digital health research. These novel methods of clinical research now allow us to provide sensitive measures of an individual’s behaviour that were previously unimaginable to obtain within a laboratory setting. Importantly, these clinical assessments are also personally relevant to patients’ daily lives and wellbeing since measurements can now be noninvasively collected during one’s day-to-day life, which also reduces the burden of the trial.

The novel application of digital health in clinical trials is already leading to innovative digital biomarkers and diagnostic tools that reduce healthcare and pharmaceutical costs, and improve patient outcomes.

Interested in discovering how to improve your clinical trials with patient-centric tehcnologies?

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References

http://www.mdpi.com/2227-9032/3/1/50/htm
https://www.ncbi.nlm.nih.gov/pubmed/28258049

Written by Nathan Cashdollar and Sally Jennings

Director of Digital Neuroscience, Nathan Cashdollar PhD