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

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Device: Vitality GlowCaps

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medication Dosage Reminders; Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email).	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.
Experimental: Medicaiton Dosage Reminders + Coordinator Support; Subject will receive electronic pill bottle that will track adherence. They will also be able to activate available dosage reminders (text message, phone message, email). The study coordinator will also check adherence every 2 weeks and alert the transplant team when it drops below 90%. The transplant team will determine the next best course of action.	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.
Other: Usual Care with GlowCap; Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Peter P Reese, MD, MSCE, University of Pennsylvania

Publications and helpful links

General Publications

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Adherence; Kidney transplant; Electronic pill bottles
• Other Study ID Numbers: 814788; K23DK078688 (U.S. NIH Grant/Contract)