NCT01541384

Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Novel wireless technology has created inexpensive tools that allow both accurate monitoring of adherence to pills as well as real-time interventions such as automated reminders in the event of a missed dose. In this study, the investigators will use Vitality GlowCaps, an electronic pill bottle. These pill bottles provide an unbiased assessment of pill bottle opening and a valid approach to verifying self-administered pill taking, reflecting not only daily use but also patterns of drug use and timing. At the prescribed times, bottle will electronically transmit whether a subject opened the pill cap to take the immunosuppressant medication via a built-in transmitter to the central server. The investigators will randomize participants to usual care, customized reminders, and customized reminders paired with provider notification in the event of low adherence. The investigators' aim: To improve immunosuppression (IS) medication adherence in kidney transplant recipients. The investigators' hypotheses: a) Automated reminders will improve adherence to immunosuppression compared to usual care, and b) Automated reminders, paired with provider notification about patients with poor adherence, will improve adherence to immunosuppression compared to usual care.

Conditions

• Medication Adherence

Interventions

Type	Name	Description
DEVICE	Vitality GlowCaps	The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT\&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function. Note: GlowCaps are a "Class 1" Medical Device registered with the FDA. Because of this Class 1 designation, they are not subject to FDA testing or approval.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-09-01
• Completion: 2015-09-01
• First posted: 2012-02-29
• Last updated: 2017-08-11
• Results posted: 2017-08-11

Locations

1 site across 1 country: United States