Follow our fictional subject, Milo, as he uses his mobile phone to participate in a clinical trial. To learn more about how you can ClamIt in your study, reach out to firstname.lastname@example.org.
Digital technology has changed the world…the way we exercise, read, communicate, and drive…and now it has changed the way we conduct clinical trials…Welcome to ClaimIt…Real-World…Real-Evidence…Really Cool.
Motivational Pill Study
Duration: 30 Days
Interventions: 150mg Once Per Day
Study Primary End-point: # of workouts per week
Secondary End-points: BMI, Cardiovascular risk factors
Secondary Measurements: BP, Blood Glucose, Teeth Brushing, Heart Rate, Sleep Score, Nutritional Intake
A social media ad catches Milo’s interests.
Hooray for Milo! He qualifies, signs up for the study, downloads the ClaimIt app and signs the e-consent.
Milo receives a package with the study supplies and records his receipt, using ClaimIt.
During a 7-day baselining period, Milo records needed study data on the ClaimIt app.
A sleep tracker monitors Milo’s sleep and shares the data with ClaimIt. As part of the study requirements, Milo takes his medicine – a motivational pill – and it is captured by ClaimIt.
Workout skipped and off to work, Milo engages the PI regarding study-related questions via ClaimIt’s Bluetooth connection with his car.
ClaimIt notifies Milo of his first milestone reward – a $100 digital gift card!
Feeling motivated, Milo stays on target and heads to the gym where his activity tracker records his metrics into ClaimIt.
Real-world evidence shows that Milo is in the groove…taking samples…recording…and confirming.
On the final day, Milo completes a final questionnaire and receives instructions on packing up his study devices.
As Milo reported taking the motivational pill, each confirmed “take time” was cross-referenced with his sleep and activity tracking devices, to confirm no overlap. Milo’s reporting of each workout was validated by his activity tracker. Occasionally, Milo may have been asked to take a quick picture of activities that he is reporting.
Let’s say one of Milo’s blood pressure readings was elevated. Milo would be asked to repeat the measurement, and then engaged by a member of the study team to explore & document the rationale behind the increase. Depending on the severity, an in-home visit by a clinician could be scheduled. As his metrics returned to normal, Milo would have been allowed to continue participating.
Over the duration of the study, the ClaimIt app proactively monitored safety data and engaged subjects with questions & content designed to capture deviations from baseline. Subjects can be given access to a telemedicine portal to engage with clinicians as needed, 24 hours a day.
Milo’s usage of the study-provided smart toothbrush and smart plate were optional additives to evaluating the complete effect of the Motivational Pill, and were ways that subject self-reporting can intelligently built-in.
The ClaimIt GPS functionality can also monitor pollution and UV indexes. Milo had a history of skin cancer and selected to be notified about these environmental changes. He received the messages about staying indoors when UV rates were high.
As ClaimIt is GDPR compliant, Milo reviewed his progress throughout the study. Milo is glad to have contributed, seeing the important results from his participation. There is a paradigm shift in how to conduct a clinical study and its’ name is ClaimIt – brought to you by ObvioHealth.