Intervention to Improve Adherence in Teen Kidney Transplant (TAKE-IT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01356277|
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : June 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation Medication Adherence||Behavioral: Action-focused problem-solving Device: Electronic pillbox monitoring, dose reminders, and feedback||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Behavioral Intervention
Participants in the intervention group will form an Adherence Support Team (AST), receive standardized adherence education, and complete behavioral intervention at 3-month intervals. In between visits, the study facilitator will maintain monthly contact with participants via short phone or text-message check-ins. The electronic pillbox will collect adherence data and will be configured to provide visual cue or text message dose reminders to participants in the intervention group. Participants in the intervention group will be fed back their electronic adherence data at each study visit.
Behavioral: Action-focused problem-solving
An Adherence Support Team (AST), consisting of the patient, one or both parents (or primary caregiver), and the study facilitator, will be formed for each participant in the intervention arm. "Action-focused problem-solving" is informed by two complementary behavioral approaches: problem-solving and implementation intentions.
Implementation intentions are concrete action plans in which an individual specifies, in an if-then or when-then contingency format, when, where, and how he or she will perform a behavior (e.g. "When I come home from school, then I will place my medication on the kitchen counter next to the microwave.").
Device: Electronic pillbox monitoring, dose reminders, and feedback
The multi-dose pillbox is coupled, using wireless technology, to a personalized, password-protected, medication management website. When a compartment of the dose box is opened, a signal is sent, and a date and time "stamp" is recorded in the electronic record of the patient to whom the device is registered. Adherence data collected with the device is fed back to participants in the intervention group. The pillboxes provide one, or any combination, of the following dose reminder methods: device light flashing, email, or text messages. The reminder method may be changed any time. The devices require only a power supply. Neither a phone line nor an Internet connection is required.
No Intervention: Standard Care
Control participants will receive an electronic pillbox to measure medication adherence. They will meet with the study facilitator at 3-month intervals to discuss general health and life issues. The dose reminder functions of the electronic pillbox will not be enabled.
- Taking adherence [ Time Frame: 12 months ]Characterize and compare, over the 12-month intervention interval, adherence patterns and levels in the intervention and control groups, as quantified by daily "taking adherence", defined as the proportion of prescribed doses taken each day (by electronic monitoring).
- Timing adherence [ Time Frame: 12 months ]Characterize and compare adherence patterns and levels in the intervention and control groups, as quantified by daily "timing adherence" (by electronic monitoring, the proportion of doses taken within 2 hours of the prescribed inter-dose interval), the rate of "Drug holidays" (periods in which ≥2 consecutive doses were missed, by electronic monitoring), variability in tacrolimus trough levels (for the subset of individuals prescribed tacrolimus),taking adherence by pharmacy records, and each of taking and timing adherence as measured using the Medication Adherence Measure (MAM) self-report tool.
- Clinical outcomes [ Time Frame: 12 months ]Compare the intervention and control groups with respect to percent change eGFR, acute rejection rate, and graft failure rate during the 12-month intervention interval.
- Healthcare system factors [ Time Frame: 12 months ]Perform observational analyses to identify independent associations between the measures of adherence described for Outcome 1 and healthcare system factors, including characteristics of the treating team (dedicated pharmacist, patient:nurse ratio, etc.), insurance status, Canadian vs. American system, and accessibility to care, adjusting for potential confounders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356277
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63130|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Canada, British Columbia|
|British Columbia Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|University of Toronto Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3G 1AF|
|St. Justine's Hospital|
|Montreal, Quebec, Canada|
|Principal Investigator:||Bethany J Foster, MD, MSCE||Montreal Children's Hospital of the MUHC|
|Principal Investigator:||Susan L Furth, MD, PhD||Children's Hospital of Philadelphia|