Leveraging Mobile Health through Innovation
Leveraging Mobile Health through Innovation
The first part of my series on mobile health (mHealth), Understanding Mobile Health Trends and Opportunities for Clinical Trials and Post-Approval Programs, focused on the basics, along with an overview of the current landscape. Now I’ll examine ways to expand the use of mobile tactics for clinical trial programs. I will share with you examples of some of the more cutting edge clinical trial technology offerings.
The Bring Your Own Device (BYOD) concept is a popular new trend, and a big one for those working in all areas of IT today. BYOD allows study participants to use personally owned mobile devices (laptops, tablets, and smart phones) to send/access privileged study information and applications. Although there are significant issues to address - security concerns, HIPAA compliance, and the uniformity of the user experience - I believe that BYOD may help patients be more compliant to study requirements, and could potentially increase patient retention because of the convenience of using their own devices.
Disease-Specific Medical Devices: Wireless health devices (such as glucose monitors or vital signs recorders) can be used to relay information to study sites. Depending on the protocol, portable hand-held devices that transmit data wirelessly might be considered, eliminating the need for some study mandated visits. With a wireless device -- for example, a spirometer for a COPD study -- the study site staff can monitor the measurements patients obtain using the device in real-time along with all other EDC device data being collected in the study. This real-time integration allows staff to view the data quickly and enables on-time analysis and decision-making regarding any patient-obtained measurement data throughout the trial.
WellDoc's BlueStar, the world's first mobile prescription therapy, is an mHealth product that created a new class of therapy for people with type 2 diabetes. BlueStar provides real-time motivational, behavioral, and educational coaching for diabetes and offers smart blood glucose testing, healthy diet and exercise choices, medication adherence, and quality standards of care such as A1c tests, foot exams, and blood pressure and lipid levels.
Study-Specific Mobile Applications: As an alternative to investigator kits to provide sites with reference material, mobile apps can provide a great deal of information in a more efficient and cost-effective way. Push alerts can also notify the sites of updates such as protocol amendments.
UBC developed a mobile app for site staff to use at the protocol level and includes an e-kit and tools for informed consent, inclusion/exclusion criteria, and patient retention. Investigators and study coordinators appreciate having ready access to study documents with updates and alerts automatically built in.
ePRO Platforms: Exco InTouch offers a validated ePRO (patient reported outcomes) platform that allows Pharma and CROs to utilize a BYOD strategy. As hardware provisioning has made ePRO expensive, utilizing a BYOD option has reduced its uptake. At EXCO, they can remotely assess a patient’s device for suitability (device type, browser, screen size) and transmit the ePRO application to that device. The program has all of the required security elements. If a patient’s device is not appropriate, a suitable device is provided. This partial provisioning not only reduces costs but allows patients to access their questionnaires on familiar devices, so it can naturally increase compliance.
Text Messaging: Omniscience Mobile developed omniCAST to provide a simple advertising response mechanism for potential study subjects, allowing people to register their interest and determine their fit with the eligibility criteria. When a prospective trial participant matches the initial screening criteria, omniCAST automatically passes that information to the sponsor for follow up. Optionally, omniCAST’s telephony component can initiate a call to the recruitment call center (or directly to the site they have been matched with), and immediately connect this prospective trial participant with a member of the study team. In previous implementations, a large majority of respondents have chosen text messaging over other response options (phone, online), and have shown a willingness to provide a large amount of information to determine their eligibility. By using omniCAST, studies are connecting with patients where they live, on their mobile phones.
Intelligence Toilet: Imagine a toilet that acts as a “sample catcher” in the bowl that can obtain urine samples directly from the study subject’s home. This could happen sooner than we think and help improve patient retention and reduce study visits. Invented by TOTO, a Japanese company, the Intelligence Toilet II includes a receptacle that collects urine samples directly from the basin, reports blood pressure and body temperature, and measures weight with an inbuilt floor scale. The readout is displayed on a wall-mounted computer screen and the data can be sent automatically to the study database.
I hope these examples spark your own creativity and lead you to incorporate these and other mHealth concepts into your next protocol design. In the third and final blog of the mHealth series, I’ll discuss important considerations when incorporating an mHealth solution in a clinical trial and provide suggestions on how to measure program effectiveness, as well as pilot and fund the program. Come on back!!