Intervention to Improve Adherence in Teen Kidney Transplant
TAKE-IT
TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial
1 other identifier
interventional
170
2 countries
8
Brief Summary
The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
July 18, 2018
CompletedJuly 18, 2018
June 1, 2018
4.3 years
May 17, 2011
April 23, 2018
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Taking Adherence
Daily "taking adherence", defined as the percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize adherence for each arm, we calculated the total percentage of days of observation for which there was 100% taking adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which taking adherence was 100%, summed across all participants.
12 months
Timing Adherence
Daily "timing adherence", defined as the percentage of doses taken within 1 hour before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize timing adherence for each arm, we calculated the total percentage of days of observation for which there was 100% timing adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which timing adherence was 100%, summed across all participants.
12 months
Secondary Outcomes (5)
Standard Deviation (SD) of Tacrolimus Trough Levels
12 months
Self-reported Taking Adherence
12 months
Self-reported Timing Adherence
12 months
Acute Rejection Rate
12 months
Annualized Change in Estimated Glomerular Filtration Rate (eGFR)
12 months
Study Arms (2)
Multi-component Intervention
EXPERIMENTALMulti-component Intervention consisting of: * Adherence Support Team (patient, parent, Coach) * standardized education on immunosuppressive medications * identification of adherence barriers * Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals * 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient * text message, email, or visual cue dose reminders
Attention control
NO INTERVENTIONControl group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
Interventions
* Adherence Support Team (patient, parent, Coach) * standardized education on immunosuppressive medications * identification of adherence barriers * 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient
* Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals * text message, email, or visual cue dose reminders
Eligibility Criteria
You may qualify if:
- Subjects age 11 - 24 years
- At least 3 months post kidney transplant
You may not qualify if:
- Significant neurocognitive disabilities limiting the subject's ability to understand and participate on their own
- Unable to communicate in English or French (Montreal site)
- Unable to communicate in English (all other sites)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centrelead
- Children's Hospital of Philadelphiacollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- Seattle Children's Hospitalcollaborator
- Washington University School of Medicinecollaborator
- British Columbia Children's Hospitalcollaborator
- The Hospital for Sick Childrencollaborator
- St. Justine's Hospitalcollaborator
- Temple Universitycollaborator
Study Sites (8)
Washington University School of Medicine
St Louis, Missouri, 63130, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
University of Toronto Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Montreal Children's Hospital
Montreal, Quebec, H3G 1AF, Canada
St. Justine's Hospital
Montreal, Quebec, Canada
Related Publications (5)
Foster BJ, Pai A, Zhao H, Furth S; TAKE-IT Study Group. The TAKE-IT study: aims, design, and methods. BMC Nephrol. 2014 Aug 30;15:139. doi: 10.1186/1471-2369-15-139.
PMID: 25176317BACKGROUNDMellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PMID: 36094829DERIVEDBoucquemont J, Pai ALH, Dharnidharka VR, Hebert D, Zelikovsky N, Amaral S, Furth SL, Foster BJ. Association between day of the week and medication adherence among adolescent and young adult kidney transplant recipients. Am J Transplant. 2020 Jan;20(1):274-281. doi: 10.1111/ajt.15590. Epub 2019 Oct 12.
PMID: 31507087DERIVEDBoucquemont J, Pai ALH, Dharnidharka VR, Hebert D, Furth SL, Foster BJ. Gender Differences in Medication Adherence Among Adolescent and Young Adult Kidney Transplant Recipients. Transplantation. 2019 Apr;103(4):798-806. doi: 10.1097/TP.0000000000002359.
PMID: 29994983DERIVEDFoster BJ, Pai ALH, Zelikovsky N, Amaral S, Bell L, Dharnidharka VR, Hebert D, Holly C, Knauper B, Matsell D, Phan V, Rogers R, Smith JM, Zhao H, Furth SL. A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT). Am J Kidney Dis. 2018 Jul;72(1):30-41. doi: 10.1053/j.ajkd.2017.12.012. Epub 2018 Mar 27.
PMID: 29602631DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Patients who withdrew or ceased to use the pillbox may introduce bias if they represented patients who were more or less adherent than those who continued to use the pillbox.
Results Point of Contact
- Title
- Dr. Bethany Foster
- Organization
- McGill University Health Centre
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
May 17, 2011
First Posted
May 19, 2011
Study Start
February 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 18, 2018
Results First Posted
July 18, 2018
Record last verified: 2018-06