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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01541384
First received: February 23, 2012
Last updated: August 29, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Medication Adherence
Device: Vitality GlowCaps

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Adherence [ Time Frame: Final 90 days ] [ Designated as safety issue: No ]
    The primary outcome will be the number of tacrolimus doses taken as directed during the final 90 days of this 180 day trial. This includes a 14 day "wash-in" period for device accustomization.


Enrollment: 120
Study Start Date: February 2012
Study Completion Date: September 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.
Experimental: 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: 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.


  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541384

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Peter P Reese, MD, MSCE University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01541384     History of Changes
Other Study ID Numbers: 814788  K23DK078688 
Study First Received: February 23, 2012
Last Updated: August 29, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Kidney transplant
Adherence
Electronic pill bottles

ClinicalTrials.gov processed this record on December 02, 2016