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

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ClinicalTrials.gov Identifier: NCT01356277
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
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
St. Justine's Hospital
Temple University
Information provided by (Responsible Party):
Beth Foster, McGill University Health Center

May 17, 2011
May 19, 2011
April 23, 2018
July 18, 2018
July 18, 2018
February 2012
June 2016   (Final data collection date for primary outcome measure)
  • Taking Adherence [ Time Frame: 12 months ]

    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.

  • Timing Adherence [ Time Frame: 12 months ]

    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.

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 in sequential 4-week intervals by "taking adherence", defined as the proportion of prescribed doses taken (by electronic monitoring).
Complete list of historical versions of study NCT01356277 on ClinicalTrials.gov Archive Site
  • Standard Deviation (SD) of Tacrolimus Trough Levels [ Time Frame: 12 months ]
    The SD of all tacrolimus trough levels done for clinical care (except during hospitalizations or illnesses) were calculated for participants with >=3 tacrolimus levels.
  • Self-reported Taking Adherence [ Time Frame: 12 months ]
    Self-reported taking adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.
  • Self-reported Timing Adherence [ Time Frame: 12 months ]
    Self-reported timing adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken up to 2 hours after the prescribed time in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.
  • Acute Rejection Rate [ Time Frame: 12 months ]
    The acute rejection rate, measured as rejections per 100 person-years of observation.
  • Annualized Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 12 months ]
    Change in estimated glomerular filtration rate, estimated using the Schwartz equation for those < 18 y. and the CKD-EPI equation for those 18y and older, standardized to a 12-month period.
  • Timing adherence [ Time Frame: 12 months ]
    Characterize and compare adherence patterns and levels in the intervention and control groups, as quantified in sequential 4-week intervals by "timing adherence" (by electronic monitoring, the proportion of doses taken within 25% 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), 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.
Not Provided
Not Provided
 
Intervention to Improve Adherence in Teen Kidney Transplant
TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial
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.
Young kidney transplant recipients at 8 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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Kidney Transplantation
  • Medication Adherence
  • Behavioral: Action-focused problem-solving
    • 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
  • Device: Electronic pillbox monitoring, dose reminders, and feedback
    • 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
    Other Names:
    • Medminder Systems
    • Maya
    • US Patent Number 5710551
    • Vaica Medical
    • SimpleMed medication reminder and dispenser
  • Experimental: Multi-component Intervention

    Multi-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
    Interventions:
    • Behavioral: Action-focused problem-solving
    • Device: Electronic pillbox monitoring, dose reminders, and feedback
  • No Intervention: Attention control
    Control 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
176
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects age 11 - 24 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)
Sexes Eligible for Study: All
11 Years to 24 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01356277
R01DK092977-01( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Beth Foster, McGill University Health Center
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
  • St. Justine's Hospital
  • Temple University
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
McGill University Health Center
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP