Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
August 11, 2017
CompletedAugust 11, 2017
August 1, 2017
2.6 years
February 23, 2012
July 12, 2017
August 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Medication Dosage Reminders
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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.
Usual Care with GlowCap
OTHERSubject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 36094829DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study did not assess clinical end points. Participants and study coordinators were not blinded to intervention arm.
Results Point of Contact
- Title
- Dr. Peter Reese
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Peter P Reese, MD, MSCE
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
February 29, 2012
Study Start
February 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2015
Last Updated
August 11, 2017
Results First Posted
August 11, 2017
Record last verified: 2017-08