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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 10, 2017
Last verified: August 2017
Results First Received: July 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition: Medication Adherence
Intervention: Device: Vitality GlowCaps

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Medication Dosage Reminders   Medicaiton Dosage Reminders + Coordinator Support   Usual Care With GlowCap
STARTED   40   40   40 
COMPLETED   40   39   38 
NOT COMPLETED   0   1   2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Medication Dosage Reminders   Medicaiton Dosage Reminders + Coordinator Support   Usual Care With GlowCap   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   40   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (12)   50  (11)   49  (11)   50  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      15  37.5%      17  42.5%      16  40.0%      48  40.0% 
Male      25  62.5%      23  57.5%      24  60.0%      72  60.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      19  47.5%      14  35.0%      15  37.5%      48  40.0% 
White      18  45.0%      24  60.0%      23  57.5%      65  54.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      3   7.5%      2   5.0%      2   5.0%      7   5.8% 
Region of Enrollment 
[Units: Participants]
       
United States   40   40   40   120 


  Outcome Measures

1.  Primary:   Immunosuppression (Tacrolimus) Adherence   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study did not assess clinical end points. Participants and study coordinators were not blinded to intervention arm.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Peter Reese
Organization: University of Pennsylvania
phone: 215-898-6086
e-mail: peter.reese@uphs.upenn.edu



Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01541384     History of Changes
Other Study ID Numbers: 814788
K23DK078688 ( U.S. NIH Grant/Contract )
Study First Received: February 23, 2012
Results First Received: July 12, 2017
Last Updated: August 10, 2017