Intervention to Improve Adherence in Teen Kidney Transplant
Condition: Kidney Transplantation; Medication Adherence
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Action-focused problem-solving; Electronic pillbox monitoring, dose reminders, and feedback
Intervention type(s): Behavioral; Device
Intervention description(s): 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
Other intervention name(s): Medminder Systems; Maya; US Patent Number 5710551; Vaica Medical; SimpleMed medication reminder and dispenser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: renal; allograft; immunosuppressive; immunosuppression; adherence; medication; compliance