Intervention to Improve Adherence in Teen Kidney Transplant (TAKE-IT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by McGill University Health Center
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Seattle Children's Hospital
Washington University School of Medicine
British Columbia Children's Hospital
The Hospital for Sick Children
Information provided by (Responsible Party):
Beth Foster, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01356277
First received: May 17, 2011
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Medication Adherence
Behavioral: Action-focused problem-solving
Device: Electronic pillbox monitoring, dosage reminders, and feedback
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Taking adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Timing adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 176
Study Start Date: February 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, dosage reminders, and feedback
The Medminder is a multi-dose pillbox that is coupled, using wireless technology, to a personalized, password-protected, medication management website. When each individual 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. The SimpleMed is a similar device, with similar functionality that transmits electronic adherence data via a standard phone line. Adherence data collected with these devices 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 Medminder requires only a power supply. Neither a phone line nor an Internet connection is required. The SimpleMed requires a power supply and a standard phone line.
Other Names:
  • Medminder Systems
  • Maya
  • US Patent Number 5710551
  • SimpleMed medication reminder and dispenser
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.

Detailed Description:

Young kidney transplant recipients at 7 pediatric transplant centers in the United States and Canada will be invited to participate. Participants will be randomly assigned to either the control or intervention group. Adherence will be measured in all participants using an electronic medication monitoring multi-dose pillbox. Enrolment will be followed by a 3-month run-in period, during which group allocation will be concealed and no intervention administered. At the 3-month visit, participants assigned to the intervention group will form an Adherence Support Team including the participant, one or both parents, and a study facilitator who is not a member of the treating team. At the same visit the facilitator will provide standardized adherence education, and will initiate a novel 20-30 min. behavioural intervention, which combines problem-solving skills with implementation intentions (concrete action plans in which an individual specifies, in an if-then contingency format, when, where and how he or she will perform a behaviour, with the goal of developing habits). This intervention will focus on addressing adherence barriers identified using the validated Medication Barriers Survey 3 and selected by the participant as important to him or her. Subsequent study visits, at 3-month intervals, will include a briefer versions of the educational component, and review and updating of implementation intentions. In addition, the electronic pillbox will be configured to provide alarm, phone, or text message dose reminders to participants in the intervention group throughout the intervention interval. Control participants will also meet with the facilitator at 3-month intervals, but will simply discuss general health and life issues; they will not receive dose reminders. In between visits, the facilitator will maintain monthly contact with all participants via short phone or text-message check-ins to troubleshoot issues with the electronic pillbox. The primary outcome will be 'taking adherence' - the proportion of prescribed doses that were consumed. Appropriate timing of doses will also be evaluated, as will variability in medication levels (reflecting consistency of medication consumption), and graft outcomes. Level of adherence, patterns of change in adherence, and graft outcomes will be compared between intervention and control groups. Secondary observational analyses of collected study data will identify healthcare systems factors independently associated with adherence.

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects age 11 - 19 years
  • At least 3 months post kidney transplant

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356277

Contacts
Contact: Bethany J Foster, MD, MSCE 514-412-4400 ext 23323 beth.foster@muhc.mcgill.ca

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63130
Contact: Vikas Dharnidharka, MD       vikasd@wustl.edu   
Principal Investigator: Vikas Dharnidharka, MD, MPH         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: Ahna Pai, PhD         
Sub-Investigator: Jens Goebel, MD         
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Susan L Furth, MD, PhD    215-590-2449      
Sub-Investigator: Nataliya Zelikovsky, PhD         
Principal Investigator: Susan Furth, MD, PhD         
Sub-Investigator: Huaqing Zhao, PhD         
Sub-Investigator: Kevin Meyers, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Jodi Smith, MD         
Sub-Investigator: Ruth McDonald, MD         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Douglas Matsell, MD       dmatsell@cw.bc.ca   
Principal Investigator: Douglas Matsell, MD         
Canada, Ontario
University of Toronto Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Diane Hebert, MD       diane.hebert@sickkids.ca   
Principal Investigator: Diane Hebert, MD         
Canada, Quebec
Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H3G 1AF
Contact: Bethany J Foster, MD, MSCE    514-412-4400 ext 23323    beth.foster@muhc.mcgill.ca   
Principal Investigator: Bethany Foster, MD, MSCE         
Sub-Investigator: Barbel Knauper, PhD         
Sub-Investigator: Lorraine Bell, MD         
Sub-Investigator: Crystal Holly, PhD         
Sponsors and Collaborators
McGill University Health Center
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Seattle Children's Hospital
Washington University School of Medicine
British Columbia Children's Hospital
The Hospital for Sick Children
Investigators
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
  More Information

No publications provided

Responsible Party: Beth Foster, Associate Professor of Pediatrics, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01356277     History of Changes
Other Study ID Numbers: R01 DK92977-01
Study First Received: May 17, 2011
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by McGill University Health Center:
renal
allograft
immunosuppressive
immunosuppression
adherence
medication
compliance

ClinicalTrials.gov processed this record on August 28, 2014