An Easy Tool to Keep Patients Protocol-Focused

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An Easy Tool to Keep Patients Protocol-Focused

Isn’t it great when you get really good, helpful customer service?  

It is a simple formula that works in any industry: give the customer just what they need, make it easy, and develop a relationship that benefits both parties. Amazon built an industry around this concept, as has Google, Zappos, Starbucks and others.

Meanwhile, in the clinical trial world, Sense Health has found customer success in using basic electronic data capture technology: text messages. Co-founder and CEO Stan Berkow noticed a problem getting participants to adhere to a protocol, especially for “lifestyle” tasks such as diet or exercise. If patients largely aren’t sticking to the protocol, what’s the point in doing the trial?

It has been established that patient reported data in clinical trials is more reliable, so extending the concept of patient engagement to protocol compliance is a natural step. As mobile phone ownership, the Internet of Things, and free hotspots become as normal as an electric plug, it’s also important to incorporate this technology as simply and naturally as possible into the clinical trial process.

Rather than pursue some of the clinical trials trends such as incentives, money or gamification, Berkow found that a human connection can make the difference to study participants.

By providing participants with a person to call or text with questions or feedback, the study was successful. There was a large staff and plenty of coordinators on hand to speak with patients, so the lab kept participants on track with the protocol just by providing them with a contact.

What could be more natural, patient-centric, and effective than that?

The text message system often acts as a low-budget version of using much more expensive technology. Speaking at the NYAS fall meeting, Berkow explained how his platform is being used in clinical trials in place of expensive technology such as wireless scales and glucometers. In a Bellevue trial, rather than asking a patient to come to a clinic every morning for a blood glucose reading, the Sense Health platform texts participants and asks for their morning readings which are then recorded. If a reading is too high, an alert is triggered.

It’s a simple system, but, in this case, it saved Bellevue the cost of purchasing wireless glucometers, and benefits participants by not requiring them to travel to a clinic every day.

The system holds a great deal of promise, but what types of cautions should companies be aware of before jumping into a text message platform? Berkow’s company keeps a close eye on:

  • Privacy - text messages are an unencrypted channel, and we should assume that participants may leave their phone out. Do not share protected health information.
  • Regulations - Need to prevent spamming participants with too many messages
  • Consent - The company uses a two-tiered approach to receive permission from participants before sending texts.

Berkow thinks the success of the platform is that it’s a simple method of communication that participants are already using in their daily lives.

What do you think of this system? Can you imagine a text message platform making a difference in a clinical trial you’ve run?

About Author

Ross Rothmeier

Medidata Vice President, Technology Solutions