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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01541384
First received: February 23, 2012
Last updated: December 17, 2013
Last verified: December 2013

February 23, 2012
December 17, 2013
February 2012
July 2014   (final data collection date for primary outcome measure)
Adherence [ Time Frame: Final 12 weeks ] [ Designated as safety issue: No ]
The primary outcome will be the number of tacrolimus doses taken as directed during the final 12 weeks of this 25 week study.
Same as current
Complete list of historical versions of study NCT01541384 on ClinicalTrials.gov Archive Site
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Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification
Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Medication Adherence
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.

  • 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).
    Intervention: Device: Vitality GlowCaps
  • 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.
    Intervention: Device: Vitality GlowCaps
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
February 2015
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult (18 years or older) kidney or kidney-pancreas transplant recipient
  • Hospital of the University of Pennsylvania kidney transplant recipient
  • Recruitment within 2 weeks of discharge date
  • Living within 120 miles of Hospital

Exclusion Criteria:

  • Vulnerable populations
  • HIV seropositive status
Both
18 Years and older
No
Contact: Adam S Mussell, MA (215) 746-4177 adam.mussell@uphs.upenn.edu
United States
 
NCT01541384
814788, K23DK078688
Yes
University of Pennsylvania
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Peter P Reese, MD, MSCE University of Pennsylvania
University of Pennsylvania
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP