Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification
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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 |
- 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2015 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Adam S Mussell, MA | (215) 746-4177 | adam.mussell@uphs.upenn.edu |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: Peter P Reese, MD, MSCE | |
| Principal Investigator: | Peter P Reese, MD, MSCE | University of Pennsylvania |
More Information
No publications provided
| 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: | October 26, 2012 |
| 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 May 19, 2013