Intervention to Improve Adherence in Teen Kidney Transplant

Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Age Range:11 - 24
Start Date:February 2012
End Date:June 2016

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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.

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)
We found this trial at
South 34th Street
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Cincinnati, OH
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
Seattle, WA
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Vancouver, British Columbia
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