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

University of Pennsylvania

Status: Completed

Conditions: Medication Adherence

Treatments: Device: Vitality GlowCaps

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01541384

814788

K23DK078688 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Medication Dosage Reminders

Experimental group

Description:

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).

Treatment:

Device: Vitality GlowCaps

Medicaiton Dosage Reminders + Coordinator Support

Experimental group

Description:

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.

Treatment:

Device: Vitality GlowCaps

Usual Care with GlowCap

Other group

Description:

Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.

Treatment:

Device: Vitality GlowCaps