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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541384
• Other study ID #: 814788
• Secondary ID: K23DK078688
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: August 10, 2017
• Start date: February 2012
• Est. completion date: September 2015

Study information

• Verified date: August 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (18 years or older) kidney or kidney-pancreas transplant recipient

• Hospital of the University of Pennsylvania (HUP) kidney transplant recipient (KTR)

• Recruitment within 2 weeks of discharge date

• Living within 120 miles of HUP

Exclusion Criteria:

• Vulnerable populations

• HIV seropositive status

• Poor English communication (which might hinder necessary communication with study coordinators)

• Discharge to care facility that handles patient medications

• Demonstrates inability or unwillingness to manage own medications

Related Conditions & MeSH terms

• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunosuppression (Tacrolimus) Adherence	The primary outcome will be the percentage of tacrolimus doses taken as directed during the final 90 days of this 180 day trial as measured by the GlowCap. This includes a 14 day "wash-in" period for device acclimatization.	90 days