Medication Adherence
Conditions
Keywords
Kidney transplant, Adherence, Electronic pill bottles
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.
Interventions
DEVICEVitality 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medication 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).
Electronic pill bottle: 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. | 40 |
| Medicaiton 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.
Electronic pill bottle: 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. | 40 |
| Usual Care With GlowCap Subject will receive electronic pill bottle that will track adherence but all reminders will be deactivated.
Electronic pill bottle: Device will remotely track adherence but reminders/alerts are deactivated. | 40 |
| Total | 120 |
Baseline characteristics
| Characteristic | Medication Dosage Reminders | Total | Usual Care With GlowCap | Medicaiton Dosage Reminders + Coordinator Support |
|---|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 12 | 50 years STANDARD_DEVIATION 11 | 49 years STANDARD_DEVIATION 11 | 50 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 48 Participants | 15 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 65 Participants | 23 Participants | 24 Participants |
| Region of Enrollment United States | 40 participants | 120 participants | 40 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 48 Participants | 16 Participants | 17 Participants |
| Sex: Female, Male Male | 25 Participants | 72 Participants | 24 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
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.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Dosage Reminders | Immunosuppression (Tacrolimus) Adherence | 78 percentage of correct tacrolimus doses | Standard Deviation 14 |
| Medicaiton Dosage Reminders + Coordinator Support | Immunosuppression (Tacrolimus) Adherence | 88 percentage of correct tacrolimus doses | Standard Deviation 13 |
| Usual Care With GlowCap | Immunosuppression (Tacrolimus) Adherence | 55 percentage of correct tacrolimus doses | Standard Deviation 17 |