Trial Outcomes & Findings for Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification (NCT NCT01541384)
NCT ID: NCT01541384
Last Updated: 2017-08-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
90 days
Results posted on
2017-08-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medication Adherence in Kidney Transplant Recipients Using Automated Reminders and Provider Notification
Baseline characteristics by cohort
| Measure |
Medication Dosage Reminders
n=40 Participants
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.
|
Medicaiton Dosage Reminders + Coordinator Support
n=40 Participants
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.
|
Usual Care With GlowCap
n=40 Participants
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.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
50 years
STANDARD_DEVIATION 11 • n=7 Participants
|
49 years
STANDARD_DEVIATION 11 • n=5 Participants
|
50 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
40 participants
n=5 Participants
|
120 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 90 daysThe 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.
Outcome measures
| Measure |
Medication Dosage Reminders
n=40 Participants
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.
|
Medicaiton Dosage Reminders + Coordinator Support
n=39 Participants
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.
|
Usual Care With GlowCap
n=38 Participants
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.
|
|---|---|---|---|
|
Immunosuppression (Tacrolimus) Adherence
|
78 percentage of correct tacrolimus doses
Standard Deviation 14
|
88 percentage of correct tacrolimus doses
Standard Deviation 13
|
55 percentage of correct tacrolimus doses
Standard Deviation 17
|
Adverse Events
Medication Dosage Reminders
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medicaiton Dosage Reminders + Coordinator Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care With GlowCap
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place