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

McGill University

Status: Completed

Conditions: Medication Adherence; Kidney Transplantation

Treatments: Device: Electronic pillbox monitoring, dose reminders, and feedback; Behavioral: Action-focused problem-solving

Study type: Interventional

Funder types: Other

Identifiers

NCT01356277

R01DK092977-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 11 to 24 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Multi-component Intervention

Experimental group

Description:

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

Treatment:

Device: Electronic pillbox monitoring, dose reminders, and feedback

Behavioral: Action-focused problem-solving

Attention control

No Intervention group

Description:

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.