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

Study Overview
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Brief Summary
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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.

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

Conditions
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Medication Adherence

Intervention / Treatment
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* Device: Vitality GlowCaps


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Dosage Reminders<br>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<br>* 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.<br>|
| Experimental: Medicaiton Dosage Reminders + Coordinator Support<br>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<br>* 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.<br>|
| Other: Usual Care with GlowCap<br>Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated. | Device: Vitality GlowCaps<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplant, Adherence, Electronic pill bottles