Clinical trial NCT01356277: Intervention to Improve Adherence in Teen Kidney Transplant
Official title: TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Medication Adherence
Keywords: renal
allograft
immunosuppressive
immunosuppression
adherence
medication
compliance
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: Children's Hospital Medical Center, Cincinnati
name: Seattle Children's Hospital
name: Washington University School of Medicine
name: British Columbia Children's Hospital
name: The Hospital for Sick Children
name: St. Justine's Hospital
name: Temple University
First posted: 2011-05-19
Enrollment: 170
Sex: ALL
Minimum age (years): 11
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Taking Adherence
timeFrame: 12 months
measure: Timing Adherence
timeFrame: 12 months
Secondary outcomes:
measure: Standard Deviation (SD) of Tacrolimus Trough Levels
timeFrame: 12 months
measure: Self-reported Taking Adherence
timeFrame: 12 months
measure: Self-reported Timing Adherence
timeFrame: 12 months
measure: Acute Rejection Rate
timeFrame: 12 months
measure: Annualized Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: University of Toronto Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: St. Justine's Hospital
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital of the MUHC
name: Bethany J Foster, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Susan L Furth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foster BJ, Pai A, Zhao H, Furth S; TAKE-IT Study Group. The TAKE-IT study: aims, design, and methods. BMC Nephrol. 2014 Aug 30;15:139. doi: 10.1186/1471-2369-15-139.
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
citation: Boucquemont J, Pai ALH, Dharnidharka VR, Hebert D, Zelikovsky N, Amaral S, Furth SL, Foster BJ. Association between day of the week and medication adherence among adolescent and young adult kidney transplant recipients. Am J Transplant. 2020 Jan;20(1):274-281. doi: 10.1111/ajt.15590. Epub 2019 Oct 12.
citation: Boucquemont J, Pai ALH, Dharnidharka VR, Hebert D, Furth SL, Foster BJ. Gender Differences in Medication Adherence Among Adolescent and Young Adult Kidney Transplant Recipients. Transplantation. 2019 Apr;103(4):798-806. doi: 10.1097/TP.0000000000002359.
citation: Foster BJ, Pai ALH, Zelikovsky N, Amaral S, Bell L, Dharnidharka VR, Hebert D, Holly C, Knauper B, Matsell D, Phan V, Rogers R, Smith JM, Zhao H, Furth SL. A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT). Am J Kidney Dis. 2018 Jul;72(1):30-41. doi: 10.1053/j.ajkd.2017.12.012. Epub 2018 Mar 27.