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

Not Applicable

Completed

• Conditions: Medication Adherence
• Interventions: Device: Vitality GlowCaps

• Registration Number: NCT01541384
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-29
• Primary Completion: 2014-09
• Study Completion: 2015-09
• Results First Submitted: 2017-07-12
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-10
• Last Update Submitted: 2017-08-10
• Results First Posted: 2017-08-11
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care with GlowCap	Vitality GlowCaps	Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.
Medication Dosage Reminders	Vitality GlowCaps	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).
Medicaiton Dosage Reminders + Coordinator Support	Vitality GlowCaps	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.

Primary Outcome Measures

Name	Time	Method
Immunosuppression (Tacrolimus) Adherence	90 days	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States