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Open Access Study protocol

The TAKE-IT study: aims, design, and methods

Bethany J Foster123*, Ahna Pai4, Huaqing Zhao5, Susan Furth67 and the TAKE-IT Study Group

Author Affiliations

1 Montreal Children’s Hospital, 2300 Tupper St, E-222, Montreal, Quebec H3H 1P3, Canada

2 Department of Pediatrics, McGill University, Montreal, Quebec, Canada

3 Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada

4 Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, 240 Albert Sabin Way, MLC 7039 S.9552, Cincinnati, OH 45229, USA

5 Department of Clinical Sciences, Temple University School of Medicine, MERB 955, 3500 N. Broad St., Philadelphia, PA 19140, USA

6 Department of Pediatrics, Children’s Hospital of Philadelphia, 3401 Civic Center Boulevard, Ste 1E15, Philadelphia, PA 19104, USA

7 Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA

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BMC Nephrology 2014, 15:139  doi:10.1186/1471-2369-15-139

Published: 30 August 2014

Abstract

Background

Effective interventions to improve immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients are desperately needed. This paper describes the aims, design, and methods of the Teen Adherence in Kidney transplant, Effectiveness of Intervention Trial (TAKE-IT) study.

Design and methods

TAKE-IT is a multicentre, prospective, open-label, parallel arm randomized controlled trial that aims to determine the effectiveness of a clinic-based intervention, including educational, organizational, and behavioural components, in improving immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients. Individuals between 11 and 24 years of age who are at least 3 months post-transplant and followed in one of the eight participating pediatric kidney transplant programs, or their affiliated adult transplant programs are eligible to participate. All participating centers are tertiary care pediatric hospitals in Canada or the United States. Adherence is monitored using an electronic multi-dose pillbox for all participants during a 3-month run-in period, followed by a 12-month intervention interval. The primary outcome is ‘taking adherence’, defined as the proportion of prescribed doses of immunosuppressive medications that were taken, as measured using electronic monitoring.

All participants meet with the study ‘Coach’ at 3 month intervals. The intervention, administered by trained lay personnel, targets common adherence barriers. In addition to forming an Adherence Support Team, intervention participants identify personal barriers to adherence and use Action-focused problem-solving to address them, have their electronic adherence data fed back to them, and have the option to receive email, text message, or visual cue dose reminders. Participants in the control group meet with the coach but do not receive the other components of the intervention. The study aims to have 75 participants in each group complete the study.

Discussion

Since recruitment began in Feb. 2012, 198 adolescents have been approached to participate, of whom 130 have completed a baseline visit. As of March 31, 2014, 125 had been randomized, and 86, 68, 61, and 50 participants had completed 6-month, 9-month, 12-month, and 15-month visits respectively.

Trial registration

Clinicaltrials.gov registration NCT01356277 (May 17, 2011).

Keywords:
Adherence; Randomized trial; Adolescent; Intervention; Kidney transplantation